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Organisation
Netherlands
Public sector
EMA

European Medicines Agency

Domenico Scarlattilaan 6
1083 HS Amsterdam, Netherlands

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines within the EU.

Established in 1995, EMA's mission is to protect and promote human and animal health by ensuring that medicines available on the EU market are safe, effective, and of high quality.

The agency facilitates the development and authorization of medicines, monitors their safety throughout their lifecycle, and provides scientific advice to support the pharmaceutical industry and healthcare professionals.

Domenico Scarlattilaan 6

1083 HS Amsterdam

Netherlands

+31 (0)88 781 6000

Past Events (219)

EMA Information Day on submission predictability of initial marketing authori... Netherlands 3 Dec 2025
Annual open meeting of the European Network of Paediatric Research at EMA (En... Netherlands 20 Nov 2025
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course... 19 Nov 2025
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal ... 19 Nov 2025
European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and H... 19 Nov 2025
Questions and answers clinic on Product Management Service (PMS) Product User... 18 Nov 2025
EMA multi-stakeholder workshop on the clinical evaluation of therapeutic radi... Netherlands 17 Nov 2025
EMA Cancer Medicines Forum (CMF) meeting with industry stakeholders on cancer... Netherlands 14 Nov 2025
5th Veterinary Big Data Stakeholder Forum Netherlands 10 Nov 2025
First EMA/HMA multi-stakeholder forum on EudraVigilance and signal detection Netherlands 5 Nov 2025
Public webinar on shortages: putting patients first Netherlands 4 Nov 2025
Workshop on the use of external controls for evidence generation in regulator... Netherlands 3 Nov 2025
ICMRA Summit 2025 Netherlands 24 Oct 2025
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal ... 22 Oct 2025
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course... 20 Oct 2025
EMA roundtable with stakeholders on the 20th anniversary of the SME Regulation 17 Oct 2025
Unlocking PMS API potential: Edit functionality training for MAHs Netherlands 16 Oct 2025
Q&A clinic on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) s... Netherlands 14 Oct 2025
Questions and answers clinic on Product Management Service (PMS) Product User... 14 Oct 2025
Fourth European Medicines Agency (EMA)-Vaccines Europe bilateral meeting Netherlands 14 Oct 2025
Q&A clinic on Substance, Organisation, Referentials Management Services Netherlands 13 Oct 2025
Q&A clinic on web-based application form functionalities for CAPs and non-CAPs Netherlands 9 Oct 2025
HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanis... 8 Oct 2025
EMA multi-stakeholder workshop on reporting and qualification of mechanistic ... 8 Oct 2025
Industry stakeholder webinar on revised environmental risk assessment guideli... Netherlands 6 Oct 2025
PMS PUI Training: Product data submission & bulk edit made easy Netherlands 6 Oct 2025
Virtual live hands-on training course for clinical trials sponsors using Eudr... Netherlands 1 Oct 2025
Questions and answers clinic on Product Management Service (PMS) Product User... 18 Sep 2025
Questions and answers clinic on Product Management Service (PMS) Product User... 28 Aug 2025
Questions and answers clinic on Product Management Service (PMS) Product User... 22 Jul 2025
Training session for patients, consumers and healthcare professionals involve... 2 Jul 2025
EMA’s 30th anniversary scientific conference - Medicines, regulation and th... 25 Jun 2025
European shortages monitoring platform (ESMP): updates and question and answe... 24 Jun 2025
Fourteenth meeting of the industry stakeholder platform on the operation of t... 23 Jun 2025
Questions and answers clinic on Product Management Service (PMS) Product User... 17 Jun 2025
Strengthening evidence generation in the EU 10 Jun 2025
EMA workshop on primary efficacy endpoints for antivirals and monoclonal anti... 5 Jun 2025
EMA/FVE info session for veterinary practitioners : Understanding the first r... 3 Jun 2025
ADRA project - information session for veterinary pharmaceutical industry 22 May 2025
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal ... 21 May 2025
Product Management Service (PMS) information day 2025 Netherlands 21 May 2025
Questions and answers clinic on Product Management Service (PMS) Product User... 19 May 2025
Clinical Trials Information System (CTIS): Walk-in clinic - May 2025 14 May 2025
EMA Open Door Day 9 May 2025
Second EMA / Alliance for Regenerative Medicine bilateral meeting 8 May 2025
Virtual live hands-on training course for clinical trials sponsors using Eudr... Netherlands 5 May 2025
Questions and answers clinic on Product Management Service (PMS) Product User... 29 Apr 2025
Quality Innovation Group (QIG) Listen and Learn Focus Group (LLFG) meeting on... 8 Apr 2025
3Rs Working Party (3RsWP) plenary meeting - Public session on the 2025-2027 w... 2 Apr 2025
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal ... 1 Apr 2025
Twelfth Industry Standing Group (ISG) meeting 28 Mar 2025
Certificates Processing System: Demo & Q&A session for Industry stakeholders ... 27 Mar 2025
Quarterly System Demo - Q1 2025 26 Mar 2025
Questions and answers clinic on Product Management Service (PMS) Product User... 25 Mar 2025
Clinical Trials Information System (CTIS) sponsor end user training programme... Netherlands 25 Mar 2025
European Shortages Monitoring Platform (ESMP) workshop on application program... 24 Mar 2025
Product Management Service (PMS) webinar : Unlocking Integration – MAH & So... 14 Mar 2025
Certificates Processing System: Demo & Q&A session for industry stakeholders 13 Mar 2025
EMA Veterinary Innovation Day 13 Mar 2025
Q&A clinic on web-based electronic Application Form (eAF) functionalities for... 13 Mar 2025
ACT EU workshop on ICH E6 R3 (principles and Annex 1) Netherlands 19 Feb 2025
Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) a... Netherlands 18 Feb 2025
European medicines agencies network strategy (EMANS) to 2028 webinar Netherlands 13 Feb 2025
Regulation (EU) 2024/568: Questions and answers clinic for the Veterinary Ind... Netherlands 11 Feb 2025
Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) a... Netherlands 11 Feb 2025
Regulation (EU) 2024/568: Questions and answers clinic for the Human Industry... Netherlands 10 Feb 2025
Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) a... Netherlands 4 Feb 2025
Clinical Trials Information System (CTIS): Walk-in clinic - January 2025 Netherlands 29 Jan 2025
Product Management Service (PMS) webinar on Product User Interface (PUI) edit... 28 Jan 2025
Questions and answers clinic on post-authorisation procedure management in IR... 17 Jan 2025
Q&A Clinic on post-authorisation procedure management in IRIS - 17 Jan 2025 17 Jan 2025
EMA/FVE webinar on veterinary prescription: conditions for using certain anti... Netherlands 16 Jan 2025
Conversations on cancer - cervical cancer treatment innovation: a collaborati... Netherlands 14 Jan 2025
Q&A Clinic on post-authorisation procedure management in IRIS 8 Jan 2025
Q&A Clinic on post-authorisation procedure management in IRIS - 8 Jan 2025 8 Jan 2025
Q&A Clinic on post-authorisation procedure management in IRIS (2) Netherlands 19 Dec 2024
Quarterly system demo - Q4 2024 Netherlands 12 Dec 2024
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal ... 11 Dec 2024
Training session for patients, consumers and healthcare professionals involve... 5 Dec 2024
LinkedIn Live session: Improving efficiency of approval process for new medic... 5 Dec 2024
UPD refresher webinar for marketing authorisation holders on volume of sales ... 5 Dec 2024
Seventh European Medicines Agency (EMA) and EFPIA bilateral meeting Netherlands 29 Nov 2024
Fifth EMA/HMA Big Data Stakeholder Forum 28 Nov 2024
Clinical Trials Information System (CTIS) sponsor end user training programme... 25 Nov 2024
Submission of Manufacturers, Manufacturing Business Operations (MBOs) and str... Netherlands 25 Nov 2024
Third European Medicines Agency (EMA) and Vaccines Europe bilateral meeting Netherlands 25 Nov 2024
Thirteenth meeting of the industry stakeholder platform on the operation of t... 22 Nov 2024
EMA risk management information day 2024 Netherlands 21 Nov 2024
Eleventh Industry Standing Group (ISG) meeting Netherlands 21 Nov 2024
Clinical Trials Information System (CTIS): Walk-in clinic - November 2024 20 Nov 2024
European Shortages Monitoring Platform training session on routine shortage r... 20 Nov 2024
European Shortages Monitoring Platform (ESMP) training session on routine sho... Netherlands 20 Nov 2024
European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and H... 20 Nov 2024
Conversations on Cancer - Pediatric Cancers: Navigating the Challenges Together 19 Nov 2024
Fourth listen-and-learn focus group meeting of the Quality Innovation Group 19 Nov 2024
Advancing regulatory science research Netherlands 18 Nov 2024
Public event: advancing regulatory science research Netherlands 18 Nov 2024
Translating innovation into access for ATMPs: 3rd EU-Innovation network multi... 15 Nov 2024
Translating innovation to access for ATMPs: 3rd EU-Innovation network multi-s... 15 Nov 2024
19th industry stakeholder platform - operation of European Union (EU) pharmac... Netherlands 15 Nov 2024
Clinical Data Publication (Policy 0070) webinar - Step 2 Netherlands 14 Nov 2024
Q&A clinic on human variations web-based electronic application form (eAF) Netherlands 14 Nov 2024
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal ... 13 Nov 2024
Training webinar on post-authorisation procedure management in IRIS for Marke... 12 Nov 2024
Second European Medicines Agency (EMA) and IPFA - PPTA global bilateral meeting Netherlands 12 Nov 2024
Linkedin Live session: A call to action against antimicrobial resistance Netherlands 11 Nov 2024
Human variation electronic application form (eAF) training session and Q&A cl... Netherlands 8 Nov 2024
Third European Medicines Agency (EMA) and European Confederation of Pharmaceu... Netherlands 7 Nov 2024
HMA/EMA multi-stakeholder workshop on artificial intelligence (AI) - enabling... 5 Nov 2024
HMA/EMA multi-stakeholder workshop on Artificial Intelligence 5 Nov 2024
Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) a... 29 Oct 2024
New fee regulation: webinar for veterinary industry stakeholders 24 Oct 2024
Paediatric Oncology Strategy Forum: 24-25 October 2024 24 Oct 2024
Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) a... 22 Oct 2024
ACT EU multi-stakeholder platform annual meeting 22 Oct 2024
Small and medium-sized enterprises info day Netherlands 18 Oct 2024
Clinical Trials Information System (CTIS): Information day 17 Oct 2024
Union Product Database webinar for veterinary marketing authorisation holders... 17 Oct 2024
Training session on Human variations web-based electronic Application Form (e... 17 Oct 2024
Clinical Trials Information System (CTIS) bitesize talk: End of transition pe... 16 Oct 2024
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal ... 16 Oct 2024
Training webinar on Product Management Service (PMS) Product User Interface (... 16 Oct 2024
Fourth veterinary big data stakeholder forum 14 Oct 2024
SPOR and xEVMPD Stakeholder Engagement Webinars : Substance, product, organis... 14 Oct 2024
SPOR and xEVMPD Stakeholder Engagement Webinars : Product Management Service ... 11 Oct 2024
SPOR and xEVMPD Stakeholder Engagement Webinars : Product Management Service ... 10 Oct 2024
Scientific Symposium on Advanced Therapy Medicinal Products - ‘Contribution... Netherlands 10 Oct 2024
SPOR and xEVMPD Stakeholder Engagement Webinars : Organisation Management Ser... 9 Oct 2024
SPOR and xEVMPD Stakeholder Engagement Webinars : Substance Management Servic... 8 Oct 2024
SPOR and xEVMPD Stakeholder Engagement Webinars : Referentials Management Ser... 7 Oct 2024
Second European Medicines Agency and COCIR bilateral meeting Netherlands 7 Oct 2024
SPOR and xEVMPD Stakeholder Engagement Webinars : SPOR Data Governance 4 Oct 2024
2024 annual workshop of the European network of paediatric research at EMA (E... 2 Oct 2024
Sixth European Medicines Agency - EuropaBio bilateral meeting Netherlands 1 Oct 2024
Joint HMA/EMA multi-stakeholder workshop on submission predictability 25 Sep 2024
Multi-stakeholder workshop on Pharmacogenomics 24 Sep 2024
Joint HMA/EMA multi-stakeholder workshop on pharmacogenomics 24 Sep 2024
Information session on the pilot for expert panels' advice for orphan med... 23 Sep 2024
Clinical Trials Information System (CTIS) sponsor end user training programme... 23 Sep 2024
EMA Account Management, what's new? 20 Sep 2024
Clinical Trials Information System (CTIS): Walk-in clinic - September 2024 18 Sep 2024
Clinical Trials Information System (CTIS): Walk-in clinic on transitioning tr... 18 Sep 2024
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal ... 18 Sep 2024
Clinical Trials Regulation (CTR) Collaborate Stakeholder meeting, supported b... 11 Sep 2024
EMA public launch event on the guideline on good pharmacovigilance practices ... 11 Sep 2024
Info session on web-based electronic Application Form (eAF) add package 18 Jul 2024
ACT EU consolidated advice pilots: information and training webinar for Appli... Netherlands 17 Jul 2024
Consolidated advice pilots: information and training webinar for Applicants Netherlands 17 Jul 2024
Public webinar on pack size submissions: from XEVMPD to product management se... 11 Jul 2024
Clinical Trials Information System (CTIS): Walk-in clinic - July 2024 10 Jul 2024
Product Management Service (PMS) Application Programming Interface (API) trai... 8 Jul 2024
Twelfth meeting of the industry stakeholder platform on research and developm... Netherlands 4 Jul 2024
EMA workshop on the challenges in drug development, regulation and clinical p... 1 Jul 2024
First EMA-Animal Health Europe annual bilateral meeting 1 Jul 2024
Multistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) rec... 1 Jul 2024
EMA press briefing on EU actions to tackle shortages of GLP-1 receptor agonists 26 Jun 2024
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal ... 26 Jun 2024
Quarterly System Demo – Q2 2024 26 Jun 2024
European Shortages Monitoring Platform Essentials and Industry Reporting Requ... 24 Jun 2024
Q&A clinic on Product Management Service (PMS) Product User Interface - 20 Ju... 20 Jun 2024
Clinical Trials Information System (CTIS) Bitesize Talk: Revised transparency... Netherlands 20 Jun 2024
New Fee Regulation: webinar for veterinary Marketing Authorisation Holders 20 Jun 2024
12th meeting of the industry stakeholder platform on the operation of the cen... 19 Jun 2024
Network Update webinar on Regulatory Procedure Management for Product Lifecyc... 18 Jun 2024
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course 18 Jun 2024
Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) m... 14 Jun 2024
Joint HMA/EMA Big Data Steering Group workshop on RWE methods 14 Jun 2024
Q&A clinic on Product Management Service (PMS) Product User Interface - 13 Ju... 13 Jun 2024
Industry Update webinar on Regulatory Procedure Management for Product Lifecy... 13 Jun 2024
Industry Update webinar on Regulatory Procedure Management for Product Lifecy... 13 Jun 2024
Clinical Trials Information System (CTIS) sponsor end user training programme... Netherlands 10 Jun 2024
Third listen-and-learn focus group meeting of the Quality Innovation Group Netherlands 4 Jun 2024
Product Management Service (PMS) Product UI and API training (access & naviga... 3 Jun 2024
EU NTC ten year anniversary event 30 May 2024
Meeting of the Executive Steering Group on Shortages and Safety of Medicinal ... Netherlands 29 May 2024
Follow up EMA and EORTC multi-stakeholder workshop on soft tissue and bone sa... 24 May 2024
EMA/FVE info session on restrictions for the use of certain antimicrobials in... 23 May 2024
EMA/FVE info session on restrictions of certain antimicrobials 23 May 2024
Q&A Clinic for IRIS Network users for transitioned regulatory procedures 23 May 2024
Clinical Trials Information System (CTIS): Walk-in clinic - May 2024 15 May 2024
CTIS Bitesize Talk: Alternate IMPD-Q and New guidance AxMP Netherlands 24 Apr 2024
Simultaneous National Scientific Advice - information and training webinar Netherlands 19 Apr 2024
Product Management Service (PMS) Info-Day Netherlands 16 Apr 2024
EMA multi-stakeholder workshop on psychedelics – Towards an EU regulatory f... Netherlands 16 Apr 2024
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: ... 15 Apr 2024
SPOR Status Update 10 Apr 2024
Clinical Trials Information System (CTIS) sponsor end user training programme... Netherlands 8 Apr 2024
Cancer Medicines Forum workshop: April 2024 Netherlands 5 Apr 2024
Cancer Medicines Forum workshop Netherlands 5 Apr 2024
Training webinar on the use of Scientific Explorer in scientific advice regul... 3 Apr 2024
Quarterly System Demo Q1 2024 26 Mar 2024
Clinical Trials Information System Webinar: Last Year of Transition 25 Mar 2024
Eighth Industry Standing Group (ISG) meeting Netherlands 25 Mar 2024
3Rs Working Party (3RsWP) plenary meeting – Public session on the 2024 work plan 20 Mar 2024
Third European Medicines Agency (EMA) and MedTech Europe bilateral meeting Netherlands 18 Mar 2024
EMA Veterinary Medicines Info Day 2024 14 Mar 2024
Clinical Trials Information System (CTIS): Walk-in clinic - March 2024 12 Mar 2024
Multi-stakeholder webinar on the HMA-EMA Catalogues of real-world data source... Netherlands 4 Mar 2024
Multi-stakeholder workshop on Data Quality Framework for Adverse Drug Reactio... 1 Mar 2024
CTIS Bitesize Talk: How to submit a transitional trial in CTIS 29 Feb 2024
EMA and European Organisation for Research and Treatment of Cancer (EORTC) wo... Netherlands 29 Feb 2024
Orphan medicines development - ask the European regulator 29 Feb 2024
Product Management Services (PMS) deep-dive webinar 22 Feb 2024
European Medicines Agency (EMA) and Federation of Veterinarians of Europe (FV... 21 Feb 2024
Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) Multi... 12 Feb 2024
Multistakeholder workshop on Patient Registries Netherlands 12 Feb 2024
ACT EU Clinical Trials Analytics Workshops Netherlands 25 Jan 2024
ACT EU Clinical Trials Analytics Workshop - January 2024 Netherlands 25 Jan 2024
Clinical Trials Information System (CTIS) sponsor end user training programme... 11 Dec 2023
Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: ... 4 Dec 2023
Joint Heads of Medicines Agencies (HMA)/European Medicines Agency (EMA) AI wo... Netherlands 20 Nov 2023
Twelfth Paediatric Oncology Strategy Forum for Medicinal Product Development ... 26 Oct 2023
Second listen-and-learn focus group meeting of the Quality Innovation Group Netherlands 12 Oct 2023
Clinical Trials Information System (CTIS) sponsor end user training programme... 10 Oct 2023
Virtual live hands-on training course for clinical trials sponsors using Eudr... 4 Oct 2023
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course... 20 Sep 2023
Clinical Trials Information System (CTIS) sponsor end user training programme... 19 Sep 2023
European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and H... 19 Sep 2023
EMA Veterinary Awareness Day 12 Sep 2023

Videos (797)

EU Big Data Stakeholder Forum 17 Mar 2021 1615971302
Industry Webinar - Introduction to RMS services and activities 17 Mar 2021 1615971302
Industry Webinar Introduction to OMS services and activities 17 Mar 2021 1615971302
CTIS - M02 CTIS Common Functionalities Part A 17 Mar 2021 1615971302
CTIS - M02 CTIS Common Functionalities Part B 17 Mar 2021 1615971302
CTIS - M02 CTIS Specific Functionalities 17 Mar 2021 1615971302
CTIS - M02 CTIS Public Website 17 Mar 2021 1615971302
CTIS - M02 CTIS Technical Environment 17 Mar 2021 1615971302
CTIS - M12 Data Protection in CTIS 17 Mar 2021 1615971302
CTIS - M11 How to respond to RFI considerations and submit a... 17 Mar 2021 1615971302
CTIS – M11 How to change a Clinical Trial Application as p... 17 Mar 2021 1615971302
CTIS – M11 How to access and view an RFI in CTIS (Sponsors) 17 Mar 2021 1615971302
CTIS - M06 How to access an initial CTA in CTIS – RMS selection 17 Mar 2021 1615971302
CTIS - M06 How to access an initial CTA in CTIS – Validati... 17 Mar 2021 1615971302
CTIS - M06 How to access an initial CTA in CTIS – Validati... 17 Mar 2021 1615971302
CTIS – M07 How to create a CT: Clinical Trial centric appr... 17 Mar 2021 1615971302
CTIS – M07 How to amend and revoke roles of registered users in CTIS 17 Mar 2021 1615971302
CTIS – M07 How to request roles and how to assign roles to... 17 Mar 2021 1615971302
CTIS - M04 How to manage the workload in CTIS - Tasks tab (Authority) 17 Mar 2021 1615971302
CTIS - M04 How to manage the workload in CTIS - Timetable 17 Mar 2021 1615971302
CTIS - M04 How to manage the workload in CTIS - RFI tab (Sponsor) 17 Mar 2021 1615971302
EMA press conference 18 Mar 2021 1616104816
EMA Public stakeholder meeting on approval, safety monitorin... 26 Mar 2021 1616796019
EMA Public stakeholder meeting on assessment, approval and r... 26 Mar 2021 1616796019
EMA Public stakeholder meeting: Expected impact of COVID-19 ... 29 Mar 2021 1617048020
EMA Public stakeholder meeting: Vaccines safety monitoring u... 29 Mar 2021 1617048020
EMA Public stakeholder meeting: Transparency and publication... 29 Mar 2021 1617048020
EMA Public stakeholder meeting: Update on approved and candi... 29 Mar 2021 1617048020
CTIS - M03 CTIS password recovery and User profile functionalities 31 Mar 2021 1617220820
CTIS - M03 Registration of a new organisation in CTIS 31 Mar 2021 1617220820
CTIS - M03 Registration of a new CTIS user 31 Mar 2021 1617220820
EMA press conference 7th April 7 Apr 2021 1617825619
Webinar on ENCePP 8 Apr 2021 1617912017
Press conference 20 Apr 2021 1618948817
Press conference 23 April 23 Apr 2021 1619208017
CTIS - M14 How to submit, update and revert a Corrective Measure (Authority) 11 May 2021 1620763218
CTIS - M14 How to create and cancel a Corrective Measure (Authority) 11 May 2021 1620763218
Press Conference 12 May 12 May 2021 1620849617
Webinar on reporting suspected side effects following admini... 20 May 2021 1621540818
SME and academia 2 part training webinar: Day 2 26 May 2021 1622059215
Veterinary Stakeholders Focus Group meeting on Limited Marke... 27 May 2021 1622145617
Press Conference 28 May 28 May 2021 1622232019
SME and academia 2 part training webinar: Day 1 31 May 2021 1622491218
EMA press briefing 17 June 2021 17 Jun 2021 1623960020
IPA programme – 2nd training – day 3 22 Jun 2021 1624392020
IPA programme – 2nd training – day 2 22 Jun 2021 1624392020
IPA programme – 2nd training – day 1 22 Jun 2021 1624392020
IPA programme – 1st training – Veterinary products parallel session 22 Jun 2021 1624392020
IPA programme – 1st training – Human products parallel session 22 Jun 2021 1624392020
IPA programme – 1st training – day 1 22 Jun 2021 1624392020
CTIS - M16 How to populate the overall inspection outcome an... 30 Jun 2021 1625083220
CTIS - M16 How to populate the Inspections section 30 Jun 2021 1625083220
CTIS - M16 How to create an inspection record and how to pop... 30 Jun 2021 1625083220
CTIS - M15 How to view and download CTs in the authority workspace 30 Jun 2021 1625083220
CTIS - M15 How to search for a CT in the authority workspace 30 Jun 2021 1625083220
CTIS - M07 How to approve requests for CTIS Administrator ro... 30 Jun 2021 1625083220
CTIS - M07 How to request the CTIS high level Administrator role via IAM 30 Jun 2021 1625083220
EMA press briefing 1July 2021 1 Jul 2021 1625169619
Joint HMA EMA Workshop on Artificial Intelligence in Medicines Regulation Day 2 2 Jul 2021 1625256017
Vet Big Data Stakeholder Forum Day 1 5 Jul 2021 1625515219
Joint HMA EMA Workshop on Artificial Intelligence in Medicines Regulation Day 1 5 Jul 2021 1625515219
Veterinary Big Data Stakeholder Forum Day 2 6 Jul 2021 1625601619
CTIS - M17 How to update and complete an ad hoc assessment 7 Jul 2021 1625688018
CTIS - M17 How to create an Ad hoc assessment – Discussion... 7 Jul 2021 1625688018
CTIS - M17 How to create an Ad hoc assessment – CT selecti... 7 Jul 2021 1625688018
The EMA Traineeship experience 8 Jul 2021 1625774422
CTIS - M18 How to search and view an ASR, and respond to RFI... 12 Jul 2021 1626120018
CTIS - M18 How to create, cancel or clear, and submit an Annual Safety Report 12 Jul 2021 1626120018
EMA press briefing 15 July 2021 15 Jul 2021 1626379221
EMA / FVE Webinar on AMEG categorisation 15 Jul 2021 1626379222
EMA press briefing 15 July 2021 20 Jul 2021 1626811218
Clinical Trials Information System (CTIS) webinar 6 Aug 2021 1628280021
Information Workshop on electronic Product Information (ePI) 10 Aug 2021 1628625618
Data Standards Strategy workshop 18 Aug 2021 1629316819
Technical workshop on real world metadata for regulatory purposes 18 Aug 2021 1629316819
6. How the EMA works with Healthcare Professionals 19 Aug 2021 1629403222
EMA press briefing 9 September 2021 9 Sep 2021 1631217619
EMA press briefing 23/09/2021 23 Sep 2021 1632427218
Introduction to Union Product Database 23 Sep 2021 1632427220
IPA Advanced Training RMP and GMP sessions 1 Oct 2021 1633118419
EMA IRIS Inspections Industry training on GMP & GCP 4 Oct 2021 1633377621
CTIS - M20 Submit ASR RFIs, assess RFI responses, and finalise ASR assessment 5 Oct 2021 1633464019
CTIS - M20 Circulate draft ASR - AR, create and consolidate considerations 5 Oct 2021 1633464019
CTIS - M20 Search and view an ASR and saMS selection 5 Oct 2021 1633464019
EMA press briefing 5 October 2021 5 Oct 2021 1633464019
EMA press briefing 21 October 2021 21 Oct 2021 1634846418
Integration of EudraGMDP and OMS Webinar for industry 26 Oct 2021 1635278419
EMA press briefing 04/11/2021 4 Nov 2021 1636063220
EMA press briefing 18 November 2021 18 Nov 2021 1637272820
EMA public stakeholder meeting on vaccines and therapeutics in the EU 25 Nov 2021 1637877624
EMA public stakeholder meeting: COVID-19 surveillance and va... 26 Nov 2021 1637964021
EMA public stakeholder meeting: Update on vaccine safety monitoring 26 Nov 2021 1637964021
EMA public stakeholder meeting: Update on approved and candi... 26 Nov 2021 1637964021
EMA public stakeholder meeting on COVID 19 vaccines and therapeutics in the EU 26 Nov 2021 1637964021
Civil society members in EMA scientific committees: an overview 2 Dec 2021 1638482420
Medicine repurposing pilot project 2 Dec 2021 1638482420
Implementation of the clinical trials regulation 2 Dec 2021 1638482420
ICH E8 Guideline on general considerations for clinical studies 2 Dec 2021 1638482420
European collaboration between regulators and Health Technol... 2 Dec 2021 1638482420
Medicamentos biossimilares na UE 8 Dec 2021 1639000822
Leki biopodobne w Unii Europejskiej 8 Dec 2021 1639000822
Biosimilar geneesmiddelen in de EU 8 Dec 2021 1639000822
Medicinali biosimilari nell'UE 8 Dec 2021 1639000822
Médicaments biosimilaires en Europe 8 Dec 2021 1639000822
Medicamentos biosimilares en la UE 8 Dec 2021 1639000822
Biosimilars in der EU 8 Dec 2021 1639000822
Clinical Trials Information System (CTIS): Virtual information day 8 Dec 2021 1639000822
EMA press briefing 9 December 2021 9 Dec 2021 1639087220
How authorised COVID-19 vaccines are monitored for safety in the EU? 9 Dec 2021 1639087220
Oto jak gwarantuje sie bezpieczeństwo szczepionek przeciwko... 10 Dec 2021 1639173623
Šādi tiek nodrošināta ES atļauto COVID-19 vakcīnu drošība. 10 Dec 2021 1639173623
Štai kaip patvirtintos vakcinos nuo COVID-19 išlieka saugios ES. 10 Dec 2021 1639173623
Így maradnak az engedélyezett COVID-19 vakcinák biztonságosak az EU-ban. 10 Dec 2021 1639173623
Ovo je način na koji odobrena cjepiva za COVID-19 ostaju sigurna u EU. 10 Dec 2021 1639173623
Voici comment est assurée la sécurité des vaccins contre ... 10 Dec 2021 1639173623
Sedasi püsivad COVID-19 vaktsiinid ELis turvalised. 10 Dec 2021 1639173623
Αυτός είναι ο τρόπος με τον οποίο... 10 Dec 2021 1639173623
So bleiben zugelassene COVID-19-Impfstoffe in der EU sicher 10 Dec 2021 1639173623
Takto je zachována bezpečnost schválených vakcín proti nemoci COVID-19 v EU. 10 Dec 2021 1639173623
Ето как одобрените ваксини срещу COVID-19 в ЕС остават безопасни. 10 Dec 2021 1639173623
Na ta način ostajajo odobrena COVID-19 cepiva varna v EU 10 Dec 2021 1639173623
Takto zostávajú autorizované vakcíny proti COVID-19 bezpečné v EÚ 10 Dec 2021 1639173623
Iată cum se menţine siguranţa vaccinurilor împotriva COVID-19 10 Dec 2021 1639173623
Webinar for SMEs and Academia on CTR/CTIS 10 Dec 2021 1639173623
Union Pharmacovigilance Database: webinar on Adverse Event Reporting 16 Dec 2021 1639692022
SME Vet Info Day 20 Dec 2021 1640037618
EMA press briefing 21 December 2021 21 Dec 2021 1640124019
EMA press briefing 11 January 2022 11 Jan 2022 1641938418
4. Session 4: Testing with EMA new process and Q&A session 12 Jan 2022 1642024817
3. Session 3: ISO ICSR implementation Technical Aspects - Pa... 12 Jan 2022 1642024817
2. Session 2: ISO ICSR implementation Technical Aspects - Part 1 12 Jan 2022 1642024817
1. Session 1: Documentation, Resources & Implementation milestones 12 Jan 2022 1642024817
Union Pharmacovigilance Database webinar on signal detection... 12 Jan 2022 1642024817
Union Pharmacovigilance Database webinar on signal detection... 12 Jan 2022 1642024817
EMA press briefing 18 January 2022 18 Jan 2022 1642543219
CTR / CTIS go-live press briefing 25 January 2022 25 Jan 2022 1643148020
EMA Veterinary Medicines Info Day 2021 - II 26 Jan 2022 1643234424
Learnings Initiative for Optimal Use of Big Data for Regulatory Purpose 27 Jan 2022 1643320823
Clinical Trials in the EU - short version 31 Jan 2022 1643666427
Clinical Trials in the EU 31 Jan 2022 1643666428
Webinar on data collection on sales and use of antimicrobials 1 Feb 2022 1643752822
EMA press briefing 3 February 2022 3 Feb 2022 1643925622
Union Product Database: how to download List of Packages (MAHs) 4 Feb 2022 1644012021
Union Product Database: search functionality (NCAs, MAHs) 4 Feb 2022 1644012022
Union Product Database: how to submit volume of sales (MAHs) 4 Feb 2022 1644012022
Union Product Database: how to submit VNRAs (MAHs) 4 Feb 2022 1644012022
Union Product Database: how to view VNRAs submissions (NCAs) 4 Feb 2022 1644012022
Union Product Database: how to view volume of sales (NCAs) 4 Feb 2022 1644012022
Union Product Database: how to create a national authorisation/procedure (NCAs) 4 Feb 2022 1644012022
Union Product Database: how to fill “Regulatory entitlemen... 4 Feb 2022 1644012022
EMA Sponsored IPA Project - advanced training on Risk Management Plans 7 Feb 2022 1644271221
Clinical Trials Information System Demonstration for CTIS stakeholders – part 1 8 Feb 2022 1644357621
Clinical Trials Information System Demonstration for CTIS stakeholders – part 2 8 Feb 2022 1644357621
prj220118b Introducing DADI Webinar on the digital applica... 10 Feb 2022 1644530418
Regulatory science research needs launch event 10 Feb 2022 1644530418
Webinar on pharmacovigilance (PhV) inspections, their qualit... 11 Feb 2022 1644616819
SPOR webinar – How to access and use the SPOR API 14 Feb 2022 1644876018
EMA press briefing 17 February 2022 17 Feb 2022 1645135221
Union Pharmacovigilance Database: webinar on signal detectio... 18 Feb 2022 1645221623
Union Pharmacovigilance Database: follow up webinar on colle... 21 Feb 2022 1645480823
CTIS - M12 Data protection in CTIS 22 Feb 2022 1645567223
Introducing DADI: webinar on the Digital Application Dataset... 22 Feb 2022 1645567223
Training recording: how to submit an application for orphan ... 1 Mar 2022 1646172021
EMA press briefing 3 March 2022 3 Mar 2022 1646344821
Union Product Database: how to fill “Veterinary medicinal ... 4 Mar 2022 1646431222
Union Product Database: how to fill “Regulatory entitlement” for a NAP (NCAs) 4 Mar 2022 1646431222
Union Product Database: how to view VNRAs submissions (MAH) 4 Mar 2022 1646431222
Union Product Database: how to fill "pharmaceutical product" section for a NAP 4 Mar 2022 1646431222
Union Product Database: how to view volume of sales (NCAs) 4 Mar 2022 1646431222
Union Product Database: how to view VNRAs submissions (NCAs) 4 Mar 2022 1646431222
Union Product Database: how to submit VNRAs (MAHs) 4 Mar 2022 1646431222
Union Product Database: how to submit volume of sales (MAHs) 4 Mar 2022 1646431222
Union Product Database: search functionality (NCAs, MAHs) 4 Mar 2022 1646431222
Union Product Database: how to download lists of packages (MAHs) 4 Mar 2022 1646431222
EU Big Data Stakeholder Forum 9 Mar 2022 1646863221
EMA press briefing 3 March 2022 10 Mar 2022 1646949621
CTIS – M10 How to submit a single substantial modification... 14 Mar 2022 1647295221
EMA press briefing 17 March 2022 17 Mar 2022 1647554421
DADI - Common factors in the FHIR data standard for Art. 57(2) and eAF 22 Mar 2022 1647986420
Union Product Database - Follow up webinar for Marketing Authorisation Holders 22 Mar 2022 1647986420
Clinical Trials Information System (CTIS) bitesize talk: Use... 25 Mar 2022 1648245618
DARWIN EU: multi stakeholder information webinar 30 Mar 2022 1648670418
System Demo DADI & PMS 7 Apr 2022 1649361617
Union Product Database: how to add a new CMS (NCAs) 11 Apr 2022 1649707219
Union Product Database: how to update product data (NCAs) 11 Apr 2022 1649707219
Union Product Database: how to view product data (NCAs, MAHs) 11 Apr 2022 1649707219
Union Product Database: how to search for notifications (NCAs, MAHs) 11 Apr 2022 1649707219
Union Product Database: how to fill “Manufactured item” ... 11 Apr 2022 1649707219
Multistakeholder Workshop on EMA’s extended mandate session 3 19 Apr 2022 1650398416
Multistakeholder Workshop on EMA’s extended mandate session 2 19 Apr 2022 1650398416
Multistakeholder Workshop on EMA’s extended mandate session 1 19 Apr 2022 1650398416
Multistakeholder Workshop on EMA’s extended mandate introduction 19 Apr 2022 1650398416
Multistakeholder Workshop on EMA’s extended mandate 19 Apr 2022 1650398416
European Immunization Week 2022 - #LongLifeForAll 28 Apr 2022 1651176020
EMA press briefing 5 May 2022 5 May 2022 1651780817
Clinical Trials Information System CTIS Walk in Clinic 5 May 2022 1651780818
Clinical Trials Information System CTIS bitesize talk: Initi... 10 May 2022 1652212822
Big Data Steering Group (BDSG) by J Kaejr (BDSG) 12 May 2022 1652385616
Engagement and Communication Plan by I. Abed (EMA) 12 May 2022 1652385616
Electronic product information (ePI) by E. Scanlan (EMA) 12 May 2022 1652385616
Data Analysis and Real World Interrogation Network (DARWIN-EU) by A. Segec (EMA) 12 May 2022 1652385616
Accelerating clinical trials in the EU (ACT-EU) by I. Den Rooijen (EMA) 12 May 2022 1652385616
Safety surveillance on vaccines and therapeutics by P. Bahri (EMA) 12 May 2022 1652385616
Update on vaccines and therapeutics by M. Cavaleri (EMA) 12 May 2022 1652385616
Clinical Trials in the EU - BG version 16 May 2022 1652731219
Clinical Trials in the EU - CZ version 16 May 2022 1652731219
Clinical Trials in the EU - DE version 16 May 2022 1652731219
Clinical Trials in the EU - DK version 16 May 2022 1652731219
Clinical Trials in the EU - EE version 16 May 2022 1652731219
Clinical Trials in the EU - EL version 16 May 2022 1652731219
Clinical Trials in the EU - EL version 16 May 2022 1652731219
Clinical Trials in the EU - ES version 16 May 2022 1652731219
Clinical Trials in the EU - FI version 16 May 2022 1652731219
Clinical Trials in the EU - FR version 16 May 2022 1652731219
Clinical Trials in the EU - GA version 16 May 2022 1652731219
Clinical Trials in the EU - HU version 16 May 2022 1652731219
Clinical Trials in the EU - IT version 16 May 2022 1652731219
Clinical Trials in the EU - LT version 16 May 2022 1652731219
Clinical Trials in the EU - LV version 16 May 2022 1652731219
Clinical Trials in the EU - MT version 16 May 2022 1652731219
Clinical Trials in the EU - NL version 16 May 2022 1652731220
Clinical Trials in the EU - PL version 16 May 2022 1652731220
Clinical Trials in the EU - PT version 16 May 2022 1652731220
Clinical Trials in the EU - RO version 16 May 2022 1652731220
Clinical Trials in the EU - SE version 16 May 2022 1652731220
Clinical Trials in the EU - SK version 16 May 2022 1652731220
Clinical Trials in the EU - SI version 16 May 2022 1652731220
Clinical Trials in the EU - EN version 16 May 2022 1652731220
Awareness raising on the development and evaluation of ATMPs vid 20 May 2022 1653076817
Engagement and Communication Plan by I. Abed (EMA) 20 May 2022 1653076817
Nitrosamines impurities by M. Filancia (EMA) 30 May 2022 1653940817
EMA press briefing 2 June 2022 30 May 2022 1653940817
Webinar for fact checkers 22 March 2022 - Questions & Answers 8 Jun 2022 1654718419
Webinar for fact checkers 22 March 22 - How to search for an... 8 Jun 2022 1654718419
Webinar for fact checkers 22 March 2022 - COVID-19 vaccines safety monitoring 8 Jun 2022 1654718419
Webinar for fact checkers 22 March 2022 - EMA’s role in th... 8 Jun 2022 1654718419
Clinical Trials Information System CTIS bitesize talk Requests for information 13 Jun 2022 1655150418
PCWP/ HCPWP joint meeting: Safety surveillance on vaccines and therapeutics 20 Jun 2022 1655755218
PCWP/ HCPWP joint meeting: Update on vaccines and therapeutics 20 Jun 2022 1655755218
PCWP/ HCPWP joint meeting: Big Data DARWIN EU® 20 Jun 2022 1655755218
PCWP/ HCPWP joint meeting: Big Data Pilot on raw data analysis 20 Jun 2022 1655755218
PCWP/ HCPWP joint meeting: Big Data General update 20 Jun 2022 1655755218
PCWP/ HCPWP joint meeting: Opening our Procedures at EMA to ... 20 Jun 2022 1655755218
Information websites on veterinary medicines in the EU - EN version 20 Jun 2022 1655755218
RMS Webinar - Introduction to RMS Activities: IAM 24 Jun 2022 1656100818
RMS Webinar - Introduction to RMS Activities 24 Jun 2022 1656100818
Quarterly system demo - 2022 27 Jun 2022 1656360021
Data Quality Framework multi-stakeholder workshop 28 Jun 2022 1656446419
i-SPOC Registration 28 Jun 2022 1656446419
Information websites on veterinary medicines in the EU - EN version 30 Jun 2022 1656619221
SPOR Webinar Process to request access to SPOR API 30 Jun 2022 1656619221
CTIS Walk in Clinic 1 Jul 2022 1656705620
How to check the authenticity of electronic certificates iss... 1 Jul 2022 1656705620
EMA press briefing 7 July 2022 5 Jul 2022 1657051219
CTIS Walk in Clinic 11 Jul 2022 1657569617
Human variations form: what will happen at go-live? 11 Jul 2022 1657569617
OMS/ RMS Webinar - Introduction to OMS/ RMS Services 13 Jul 2022 1657742420
OMS Introduction to CMDh 20 Jul 2022 1658347217
Clinical Trials Information System CTIS: Walk in clinic 22 Jul 2022 1658520018
CTIS Walk in Clinic 25 Jul 2022 1658779219
Webinar on Submissions of Parallel Distribution Notifications for CAP 27 Jul 2022 1658952018
Recording of EMA Veterinary Info Day on 12 May 2022 27 Jul 2022 1658952018
Clinical Trials Information System CTIS bitesize talk: Modifications 27 Jul 2022 1658952018
EMA Veterinary Info Day on 13 May 2022 28 Jul 2022 1659038419
Clinical Trials Information System CTIS Walk in clinic 28 Jul 2022 1659038419
1st DADI Access Management Troubleshooting Session’ 29 Jul 2022 1659124820
System Demo 28 June 2022 2 Aug 2022 1659470420
EMA and FVE webinar on the Union Product Database website 2 Aug 2022 1659470420
CTIS bitesize talk: Transitional trials and additional MSC application 2 Aug 2022 1659470420
Veterinary medicines in the EU - EE version 25 Aug 2022 1661457622
Veterinary medicines in the EU - ES version 25 Aug 2022 1661457622
Veterinary medicines in the EU - GR version 25 Aug 2022 1661457622
Veterinary medicines in the EU - DE version 25 Aug 2022 1661457622
Veterinary medicines in the EU - DK version 25 Aug 2022 1661457622
Veterinary medicines in the EU - CZ version 25 Aug 2022 1661457622
Veterinary medicines in the EU - SE version 25 Aug 2022 1661457622
Veterinary medicines in the EU - SL version 25 Aug 2022 1661457622
Veterinary medicines in the EU - SK version 25 Aug 2022 1661457622
Veterinary medicines in the EU - RO version 25 Aug 2022 1661457622
Veterinary medicines in the EU - PT version 25 Aug 2022 1661457622
Veterinary medicines in the EU - PL version 25 Aug 2022 1661457622
Veterinary medicines in the EU - NO version 25 Aug 2022 1661457622
Veterinary medicines in the EU - NL version 25 Aug 2022 1661457622
Veterinary medicines in the EU - MT version 25 Aug 2022 1661457622
Veterinary medicines in the EU - LV version 25 Aug 2022 1661457622
Veterinary medicines in the EU - LT version 25 Aug 2022 1661457622
Veterinary medicines in the EU - BG version 25 Aug 2022 1661457622
Veterinary medicines in the EU - FI version 25 Aug 2022 1661457622
Veterinary medicines in the EU - FR version 25 Aug 2022 1661457622
Veterinary medicines in the EU - IE version 25 Aug 2022 1661457622
Veterinary medicines in the EU - HR version 25 Aug 2022 1661457622
Veterinary medicines in the EU - HU version 25 Aug 2022 1661457622
Veterinary medicines in the EU - IS version 25 Aug 2022 1661457622
Veterinary medicines in the EU - IT version 25 Aug 2022 1661457622
Clinical Trials Information System CTIS webinar: Six months ... 30 Aug 2022 1661889619
EMA press briefing 2 September 2022 31 Aug 2022 1661976020
CTIS Bitesize talk: Deferral rules and Public website 1 Sep 2022 1662062422
DADI Go-Live - Q&A Webinar 7 Sep 2022 1662580822
EMA Press briefing on Tuesday, 20 September 13 Sep 2022 1663099221
Clinical Trials Information System (CTIS): Walk-in clinic 14 Sep 2022 1663185622
1st DADI eAF Training Webinar 15 Sep 2022 1663272021
NCA Training for GVP Inspections 16 Sep 2022 1663358427
Industry Training for GVP Inspections 17 Sep 2022 1663444822
2nd DADI eAF Training Webinar’ 19 Sep 2022 1663617622
Organisation Management Service (OMS) Trouble Shooting Sessions for CTIS users 20 Sep 2022 1663704022
Organisation Management System (OMS) for CTIS users 20 Sep 2022 1663704022
Submit A1a VNRA-automation(MAH) 21 Sep 2022 1663790422
View A1a VNRA Approve Reject for NCA 21 Sep 2022 1663790422
EMA workshop on patient experience data in medicines develop... 23 Sep 2022 1663963221
System Demo Q3-2022 23 Sep 2022 1663963221
XEVMPD Information session: Industry Webinar 12 Oct 2022 1665604822
Podobna biološka zdravila v Evropski uniji 13 Oct 2022 1665691221
EMA press briefing 26 October 2022 24 Oct 2022 1666641622
Clinical Trials Information System (CTIS) bitesize talk: Notifications - Part 1 25 Oct 2022 1666728044
EMA Account Management training webinar 25 Oct 2022 1666728044
Clinical Trials Information System (CTIS): Walk-in clinic 25 Oct 2022 1666728044
Introduction to Referential Management Service (RMS): Industry Webinar 26 Oct 2022 1666814425
UPD: webinar on variations not requiring assessment (VNRAs) ... 26 Oct 2022 1666814425
UPD Webinar on variations not requiring assessment VNRAs 28 Oct 2022 1666987222
ACT EU multi stakeholder workshop on Decentralised Clinical Trials 31 Oct 2022 1667253621
Webinar introducing the Data Quality Framework for EU medici... 3 Nov 2022 1667512825
How to fill in the “Finalisation” section of the eAF on the PLM Portal 4 Nov 2022 1667599222
How to fill in the “Additional Information” section of the eAF on the PLM Portal 4 Nov 2022 1667599222
How to fill in the “Procedural Information” section of the eAF on the PLM Portal 4 Nov 2022 1667599222
How to select the scope of the variation application on the PLM Portal 4 Nov 2022 1667599222
How to monitor Application Forms Status on the PLM Portal 4 Nov 2022 1667599222
EMA System Demo Q4-2022 14 Nov 2022 1668463223
Introduction to Health Technology Assessment (HTA) 17 Nov 2022 1668722434
What EMA does to tackle #AntimicrobialResistance 18 Nov 2022 1668808821
Human Variations eAF (DADI) go-live Q&A session 21 Nov 2022 1669037629
EMA press briefing 24 November 2022 21 Nov 2022 1669037629
Organisation Management System (OMS) Trouble Shooting Sessio... 22 Nov 2022 1669154420
How to fill in the "Product selection" section of the eAF on the PLM Portal 28 Nov 2022 1669672820
Human Variations eAF (DADI) training session 28 Nov 2022 1669672820
General overview of the PLM Portal 28 Nov 2022 1669672821
How to create a new application form on the PLM Portal 28 Nov 2022 1669672821
How to fill in the "Proposed changes" section of the eAF on the PLM Portal 28 Nov 2022 1669672821
Requesting access to and using EMA's substance, product, org... 2 Dec 2022 1670018422
Industry Webinar – Introduction to OMS services and activi... 2 Dec 2022 1670018422
EMA Press Briefing 16 December 2022 12 Dec 2022 1670882420
System Demo Q3 2022 19 Dec 2022 1671487221
Human Variations eAF Q&A Clinic #1 20 Dec 2022 1671573621
How to submit VNRAs related to the ATCvet code (MAHs) 20 Dec 2022 1671573621
How to approve/reject VNRAs related with changes to QPPV and... 20 Dec 2022 1671573621
How to submit VNRAs related to PSMF information (MAHs) 20 Dec 2022 1671573621
How to submit VNRAs related to QPPV information (MAHs) 20 Dec 2022 1671573621
prj221122 Human Variations eAF Q&A Clinic #2 11 Jan 2023 1673474420
CTIS Bitesize talk 23 Nov 22 11 Jan 2023 1673474420
Lessons learnt from COVID 19 13 Jan 2023 1673647222
The delivery under the EMA:EUnetHTA 21 work plan focus on en... 13 Jan 2023 1673647223
Implementation of Regulation EU 2021:2282 on Health Technology Assessment 13 Jan 2023 1673647223
Update on EU guidance on shortage prevention and communication to the public 13 Jan 2023 1673647223
Preparation for multistakeholder workshop in 2023 13 Jan 2023 1673647223
Reporting of shortages by organisations 13 Jan 2023 1673647223
Report from EMA Multistakeholder Workshop on Patient Experience Data 13 Jan 2023 1673647224
Update on the TF AAM activities 13 Jan 2023 1673647224
CIOMS report on ‘Patient involvement in the development, r... 13 Jan 2023 1673647224
Bioloogiliselt sarnased ravimid Euroopa Liidus 13 Jan 2023 1673647224
Biosimilární léky v Evropské unii 13 Jan 2023 1673647224
Human Variations eAF Q&A Clinic #3 16 Jan 2023 1673906420
Union Pharmacovigilance Database: refresher webinar on signa... 19 Jan 2023 1674165622
CTIS Walk in Clinic 25 Jan 2023 1674684022
Technical briefing on RNA technology 3 Feb 2023 1675461620
Human Variations eAF Q&A Clinic #5 3 Feb 2023 1675461620
Human Variations eAF Training 6 Feb 2023 1675720820
eAF Q&A Clinic #6 6 Feb 2023 1675720820
eAF Q&A Clinic #4 6 Feb 2023 1675720820
Second Veterinary Big Data Stakeholder Forum 8 Feb 2023 1675893621
Regulatory & scientific conference on RNA based medicines 9 Feb 2023 1675980021
EMA/HMA Big Data Stakeholder Forum 2022 10 Feb 2023 1676066422
eAF Human Variations Training 13 Feb 2023 1676325620
EMA press briefing 15 February 2023 13 Feb 2023 1676325620
How to download a PDF file with VNRA submission 14 Feb 2023 1676412020
eAF Human Variations Training 22 Feb 2023 1677103218
Academic Pilot for ATMPs webinar 23 Feb 2023 1677189619
eAF Q&A Clinic #7 24 Feb 2023 1677276018
Session 4: Permanent withdrawals from the market 8 Mar 2023 1678312818
Session 6: Work ahead to 2025 8 Mar 2023 1678312818
Session 5: Communication and transparency 8 Mar 2023 1678312818
Session 3: Prevention of shortages 8 Mar 2023 1678312818
Welcome and summary of day 1 8 Mar 2023 1678312818
Breakout session 2B: Biosimilars 8 Mar 2023 1678312818
Session 1: Setting the scene 8 Mar 2023 1678312818
Breakout session 2C: Medicines for veterinary use 8 Mar 2023 1678312818
Breakout session 2A: Immunoglobulins 8 Mar 2023 1678312818
EMA Veterinary Medicines Info Day 2023 Day II 9 Mar 2023 1678399217
EMA Veterinary Medicines Info Day 2023 Day I 9 Mar 2023 1678399217
Product Management Service (PMS) Webinar on Data Migration 10 Mar 2023 1678485618
Quarterly System Demo - Q1 2023 13 Mar 2023 1678744819
How to Submit VNRAs (MAHs) 15 Mar 2023 1678917618
Approve and reject VNRA code A.4 (NCAs) 15 Mar 2023 1678917618
Extended automatic logout (MAHs and NCAs) 15 Mar 2023 1678917618
How to run a search by VNRA submission (MAHs and NCAs) 15 Mar 2023 1678917618
What is EU-M4all? - Video Explainer 16 Mar 2023 1679004019
Interchangeability of Biosimilars - Video Explainer 16 Mar 2023 1679004019
What is a Biosimilar? - Video Explainer 16 Mar 2023 1679004019
How to approve/reject VNRA code A.4 (ATCvet code) 21 Mar 2023 1679436026
How to run a search by submissions 21 Mar 2023 1679436026
Extended automatic logout (MAHs and NCAs) 21 Mar 2023 1679436026
PCWP and HCPWP joint meeting - 3 March 2023 23 Mar 2023 1679608819
Feedback on mini campaigns 30 Mar 2023 1680206419
Multilingualism on the EMA website and in externa communications – a new policy 30 Mar 2023 1680206419
EMA’s statement on interchangeability of biosimilars 30 Mar 2023 1680206419
Update and report from Shortage workshop breakout session 30 Mar 2023 1680206419
ACT EU Multistakeholder platform: concept paper consultation... 30 Mar 2023 1680206419
Medical Device Regulation 30 Mar 2023 1680206419
PDCO Feedback 30 Mar 2023 1680206419
HMPC Feedback 30 Mar 2023 1680206419
COMP Feedback 30 Mar 2023 1680206419
CHMP Feedback 30 Mar 2023 1680206419
CAT Feedback 30 Mar 2023 1680206419
3 Rs Working Party 30 Mar 2023 1680206419
Methodology Working Party 30 Mar 2023 1680206419
SAWP – interaction with other WPs 30 Mar 2023 1680206419
Reorganisation of EMA Working Parties 30 Mar 2023 1680206419
EMA Working for every patient in Europe - (multi-language) 13 Apr 2023 1681416018
EMA Keeping medicines safe - (multi-language) 13 Apr 2023 1681416018
EMA From lab to patient - (multi-language) 13 Apr 2023 1681416018
Biosimilars - (multi-language) 13 Apr 2023 1681416018
Why we need to protect our children from vaccine-preventable diseases 24 Apr 2023 1682366420
Referentials Management Services 26 Apr 2023 1682539217
Organisation Management Service (OMS) 26 Apr 2023 1682539217
Why vaccination against HPV is important for children and teenagers 26 Apr 2023 1682539217
Why starting a conversation with your patients about vaccination? 28 Apr 2023 1682712018
Why vaccination against HPV protects boys and girls when they are adults 28 Apr 2023 1682712018
Why is important for doctors, pharmacists and nurses to disc... 28 Apr 2023 1682712018
Union Product Database: Submission of volume of sales data 2 May 2023 1683057618
Early contact by CHMP 4 May 2023 1683230418
What are Orphan Medicines? - Video explainer 5 May 2023 1683316818
SPOR and XEVMP Governance 10 May 2023 1683748819
Product Management Services (XEVMPD) 10 May 2023 1683748819
EMA multi stakeholder workshop on Qualification of novel methodologies - DAY I 16 May 2023 1684267220
EMA multi stakeholder workshop on Qualification of novel methodologies - DAY II 16 May 2023 1684267221
Substance, product, organisation and referential application... 16 May 2023 1684267221
EMA Account Management 16 May 2023 1684267221
Substance Management Service (SMS) 16 May 2023 1684267221
Service Desk for SPOR and XEVMPD 16 May 2023 1684267221
Clinical Data Publication (Policy 0070) re-launch - EMA webinar 25 May 2023 1685044820
EMA press briefing 6 June 2023 31 May 2023 1685563219
Navigating the age of pandemics with Peter Piot 2 Jun 2023 1685736020
Union Product Database: How to upload documents via UI (NCA) 7 Jun 2023 1686168020
Union Product Database: Create/ update product – Ingredient section (NCA) 7 Jun 2023 1686168020
Union Product Database: Upload document (NCA) 7 Jun 2023 1686168020
Product Management Service progress webinar 12 Jun 2023 1686600020
Quarterly System Demo - Q2 2023 19 Jun 2023 1687204820
eAF-PMS Q&A Clinic - Session 1 23 Jun 2023 1687550420
Focus Group meeting on bacteriophages 23 Jun 2023 1687550420
ACT EU multi-stakeholder platform kick-off workshop 22 June 2023 30 Jun 2023 1688155218
ACT EU multi-stakeholder platform kick-off workshop 23 June 2023 30 Jun 2023 1688155218
Webinar on revision of the pharmaceutical legislation 3 Jul 2023 1688414421
Identifying pending VNRA submission (CAs) 5 Jul 2023 1688587218
Product grouping (MAHs) 5 Jul 2023 1688587218
Addressing mis- and disinformation 6 Jul 2023 1688673619
EMA communication perception survey to PCWP 6 Jul 2023 1688673619
Follow up on suggestion for new mandate proposed by PCWP members 6 Jul 2023 1688673619
Feedback from the satisfaction survey 6 Jul 2023 1688673619
Introduction to the revamp of the Human Medicines Highlights... 6 Jul 2023 1688673619
Decentralised clinical trials 6 Jul 2023 1688673619
ACT EU – feedback from kick off meeting of multi-stakeholder platform (MSP) 6 Jul 2023 1688673619
Report on PhV tasks from EU Member States and EMA 2019 - 2022 6 Jul 2023 1688673619
Patient Experience Data update 6 Jul 2023 1688673619
Update on activities linked to presence of N-nitrosamines in human medicines 6 Jul 2023 1688673619
Implementation of the Good practice guide on prevention and ... 6 Jul 2023 1688673619
Feedback on the pilot on collecting information on shortages... 6 Jul 2023 1688673619
Monitoring of events and preparedness PCWP HCPWP 6 Jul 2023 1688673619
Piloting creation of electronic product information (ePI) for EU medicines 6 Jul 2023 1688673619
Update on RWE including DARWIN EU® 6 Jul 2023 1688673619
IPA Training on Quality and Inspections - Seminar 7 11 Jul 2023 1689105618
IPA Training on Quality and Inspections - Seminar 6 11 Jul 2023 1689105618
IPA Training on Quality and Inspections - Seminar 4 11 Jul 2023 1689105618
IPA Training on Quality and Inspections - Seminar 3 11 Jul 2023 1689105618
IPA Training on Quality and Inspections - Seminar 2 11 Jul 2023 1689105618
IPA Training on Quality and Inspections - Seminar 1 11 Jul 2023 1689105618
Human variations electronic Application Form PMS Q&A clinics – Session 2 11 Jul 2023 1689105618
Looking ahead 12 Jul 2023 1689192018
Where we are today 12 Jul 2023 1689192018
Opening remarks and beginning of our journey 12 Jul 2023 1689192018
What is the CHMP? 25 Jul 2023 1690315217
What are the PCWP and HCPWP? 18 Aug 2023 1692388820
Multi stakeholder workshop on Real World Data RWD 8 Sep 2023 1694203221
Quarterly System Demo Q3-2023 11 Sep 2023 1694462422
How to validate csv files for VoS (MAHs) 15 Sep 2023 1694808023
Informative Webinar on Regulatory Procedure Management for P... 19 Sep 2023 1695153622
Accelerating Clinical Trials in the EU (ACT EU) 19 Sep 2023 1695153622
EMA Press Briefing 19 Sep 2023 1695153622
Informative Webinar on Regulatory Procedure Management for P... 21 Sep 2023 1695326422
How to save and resume draft submissions 22 Sep 2023 1695412822
How to create a pet product 29 Sep 2023 1696017621
How to manage third country product names 29 Sep 2023 1696017621
Webinar on transparency rules for the EU Clinical Trials Information System CTIS 6 Oct 2023 1696622421
Organisation Management Service (OMS) 10 Oct 2023 1696968021
‘Communication of anticancer drug benefits and related unc... 11 Oct 2023 1697054421
Mis- and disinformation 11 Oct 2023 1697054421
Social media strategy 11 Oct 2023 1697054421
ACT EU Multi-stakeholder platform (MSP) advisory group update 11 Oct 2023 1697054421
ICH E21 Concept paper on inclusion of pregnant and breastfee... 11 Oct 2023 1697054421
Update on preparedness activities 11 Oct 2023 1697054421
Revision of QRD template for package leaflet (PL) improvement 11 Oct 2023 1697054421
EU list of critical medicines 11 Oct 2023 1697054421
Results from surveys on medicine shortages 11 Oct 2023 1697054421
Big Data Steering Group updates 11 Oct 2023 1697054421
Clinical trials in emergency situations 11 Oct 2023 1697054421
Medicines Shortages Steering Group (MSSG) 11 Oct 2023 1697054421
Emergency Task Force (ETF) 11 Oct 2023 1697054421
Referentials Management Service (RMS) 17 Oct 2023 1697572821
Substance Management Service (SMS) 18 Oct 2023 1697659221
SPOR Data Governance 19 Oct 2023 1697745621
Substance, product, organisation and referential (SPOR) appl... 23 Oct 2023 1698091222
Service Desk for SPOR and XEVMPD 23 Oct 2023 1698091222
Product Management Service (XEVMPD)​ 23 Oct 2023 1698091222
How does EMA ensure the safety of medicines in the EU 23 Oct 2023 1698091222
EMA Account Management 24 Oct 2023 1698177621
What EMA does for public and animal health 31 Oct 2023 1698789623
Session 6: Contribution of EMA and the EU network to veterinary medicines 31 Oct 2023 1698789623
Session 5: Feedback from breakout sessions 31 Oct 2023 1698789623
Breakout session 4.2: Collaboration with Academia 31 Oct 2023 1698789623
Breakout session 4.1: Animal Welfare 31 Oct 2023 1698789623
Breakout session 3.2: The impact of animals in society 31 Oct 2023 1698789623
Breakout session 3.1: Veterinary Medicines and the Environment 31 Oct 2023 1698789623
Session 2: Combatting the emergence of antimicrobial resistance 31 Oct 2023 1698789623
Session 1: A new veterinary medicines regulation - one year in operation 31 Oct 2023 1698789623
10 years of Global Collaboration in Medicine Regulation! 9 Nov 2023 1699567220
10 years of Global Collaboration in Medicine Regulation! 9 Nov 2023 1699567220
Update on H Variations web based eAF implementation on PLM Portal 10 Nov 2023 1699653620
What Europe is doing to fight Antibiotic Resistance 20 Nov 2023 1700517621
How do we fight antibiotic resistance in Europe? 20 Nov 2023 1700517621
Academia Info Day 20 Nov 2023 1700517621
Quarterly System Demo Q4 - 2023 28 Nov 2023 1701208820
COVID-19 key facts 1 Dec 2023 1701468021
Awarenes session for SMEs on the revision of the pharmaceutical legislation 6 Dec 2023 1701900039
COVID-19 key facts 8 Dec 2023 1702072822
Searching for products via Procedure number 11 Dec 2023 1702332022
Upload document (bulk upload functionality) 11 Dec 2023 1702332022
Joint Heads of Medicines Agencies (HMA)/ (EMA) AI workshop ... 13 Dec 2023 1702504821
Joint Heads of Medicines Agencies (HMA)/ (EMA) AI workshop ... 13 Dec 2023 1702504821
Product Lifecycle Management (PLM) Value Stream Deep-Dive Webinar 15 Dec 2023 1702677622
Quarterly System Demo Q4-2023 10 Jan 2024 1704924021
4th HMA/EMA Big Data Stakeholder Forum 10 Jan 2024 1704924021
EMA press briefing 16 January 2024 11 Jan 2024 1705010422
Third Veterinary Big Data Stakeholder Forum 18 Jan 2024 1705615221
Approve/reject VNRA codes A1a C10a C10c 19 Jan 2024 1705701623
Network users training for Regulatory Procedure Management 1st roll-out on IRIS 24 Jan 2024 1706133621
EMA and EORTC soft tissue and bone sarcoma workshop 6 Feb 2024 1707256820
Update webinar on Regulatory Procedure Management for PLM on IRIS 16 Feb 2024 1708120821
ASU video 5 - How to upload an ASU use template 27 Feb 2024 1709071223
ASU video 4 - How to download an ASU use template 27 Feb 2024 1709071223
ASU video 3 - How to upload, validate and submit an ASU dataset 27 Feb 2024 1709071223
ASU video 2 - How to download an ASU template 27 Feb 2024 1709071223
ASU video 1 - How to login to the ASU Platform and navigate ... 27 Feb 2024 1709071223
Product Management Services (PMS) deep-dive webinar 4 Mar 2024 1709589620
HMA/EMA Workshop on Patient Registries 5 Mar 2024 1709676020
Technical Webinar: Regulatory Procedure Management for PLM i... 7 Mar 2024 1709848821
EMA/EORTC workshop: How can PRO and HRQoL data inform regulatory decisions? 12 Mar 2024 1710280822
Video 49: How to view and approve/reject VNRA Supergrouping submissions (NCAs) 12 Mar 2024 1710280822
Video 48: How to submit VNRA Supergrouping (MAHs) 12 Mar 2024 1710280822
Video 47: Identifying pending VNRA submissions 12 Mar 2024 1710280822
Orphan Medicines Development - ask the European Regulator 13 Mar 2024 1710367221
Multi-stakeholder workshop on data quality framework for Adv... 14 Mar 2024 1710453620
EMA/FVE info session on the UPD public portal 19 Mar 2024 1710885621
System Demo 24Q1 - Public Broadcast 22 Mar 2024 1711144821
Multi-stakeholder webinar on HMA-EMA Catalogues of real-worl... 1 Apr 2024 1712001620
Multi-stakeholder webinar on HMA-EMA Catalogues of real-worl... 1 Apr 2024 1712001620
Multi-stakeholder webinar on HMA-EMA Catalogues of real-worl... 1 Apr 2024 1712001620
Multi-stakeholder webinar on HMA-EMA Catalogues of real-worl... 1 Apr 2024 1712001620
3Rs Working Party (3RsWP) plenary meeting – Public session on the 2024 work plan 2 Apr 2024 1712088021
Cancer Medicines Forum workshop 10 Apr 2024 1712779221
Learn about Traineeship Opportunities at EMA 12 Apr 2024 1712952021
SPOR Data Update 12 Apr 2024 1712952021
Use Facts and Science when Deciding on Vaccination 22 Apr 2024 1713816021
Relying on Facts and Science is an Act of Self-Care 22 Apr 2024 1713816021
Patient Experience Data Webinar (PED) 23 Apr 2024 1713902421
SNSA information & training Webinar 24 Apr 2024 1713988820
Session 3: Ensuring safe and effective real world use – Q&A and Panel discussion 30 Apr 2024 1714507220
Session 3: Ensuring safe and effective real world use - Presentations 30 Apr 2024 1714507220
Session 2: Trial design for psychedelic assisted therapies ... 30 Apr 2024 1714507220
Session 2: Trial design for psychedelic assisted therapies – Presentation 30 Apr 2024 1714507220
Session 1: From development to patient use: opportunities & ... 30 Apr 2024 1714507220
Session 1: From development to patient use: opportunities & ... 30 Apr 2024 1714507220
CTIS Bitesize Talk: Alternate IMPD-Q and New guidance AxMP 30 Apr 2024 1714507220
RMP publication process update 3 May 2024 1714766420
Act Now: Transition Your Clinical Trials to CTIS | Important... 3 May 2024 1714766420
Product Management Service Info-Day 6 May 2024 1715025620
One Health in Action: How EU Agencies are Tackling Environme... 8 May 2024 1715198420
One Health in Action: How EU Agencies are Tackling Environme... 8 May 2024 1715198420
Updated CAPs in web-based eAF information and Q&A session 15 May 2024 1715803222
EMA LinkedIn Live session on psychedelics and their therapeutic use 15 May 2024 1715803222
Transition Your Clinical Trials to CTIS 23 May 2024 1716494424
Cancer Medicines Forum workshop 28 May 2024 1716926423
ESMP Essentials and Industry Reporting Requirements 29 May 2024 1717012821
Cancer Medicines Forum workshop - video of the Belgian Health minister 30 May 2024 1717099223
Video 50: How to save and resume a draft VNRA submission 5 Jun 2024 1717617621
Joint EMA EORTC follow up workshop on soft tissue and bone sarcoma workshop 7 Jun 2024 1717790421
Webinar Pilot to provide Scientific Advice to manufactures o... 10 Jun 2024 1718049622
Joint EMA EORTC follow up workshop on soft tissue and bone sarcoma workshop 10 Jun 2024 1718049622
Public System Demo Q2/2024 10 Jun 2024 1718049622
Product Management Service (PMS) Product UI training (access & navigation) 11 Jun 2024 1718136022
prj240611 S3 Efficacy endpoints in oncology 18 Jun 2024 1718740821
prj240611 S1 Overview of EMA-approved anti-cancer products 18 Jun 2024 1718740821
prj240611 G6 Case studies 18 Jun 2024 1718740821
prj240611 G5 Input CTD application, Output regulators’ assessment report 18 Jun 2024 1718740821
prj240611 G4 Propaedeutic for benefit-risk assessment 18 Jun 2024 1718740821
prj240611 G3 How do centralised procedures work 18 Jun 2024 1718740821
prj240611 G2 How does scientific advice work? 18 Jun 2024 1718740821
prj240611 G1 Introduction: Overview of the regulation of medicines in Europe 18 Jun 2024 1718740821
prj240611 S2 Overview of guidelines 19 Jun 2024 1718827222
prj240611 EMA HMA Pilot Educational Program Oncology G4 19 Jun 2024 1718827222
EMA press briefing 26 June 2024 26 Jun 2024 1719432021
S4 Biomarkers and companion diagnostics 27 Jun 2024 1719518421
Joint HMA/EMA Big Data Steering Group Workshop on RWE Methods 28 Jun 2024 1719604821
CTIS Bitesize talks 1 Jul 2024 1719864022
Industry Update webinar on Regulatory Procedure Management f... 4 Jul 2024 1720123221
New Fee Regulation: webinar for veterinary Marketing Authorisation Holders 4 Jul 2024 1720123221
PMS Product UI Q&A Clinic (1) - 6 June 2024 9 Jul 2024 1720555221
PMS Product UI Q&A Clinic (2) - 13 June 2024 9 Jul 2024 1720555221
PMS Product UI Q&A Clinic (3) - 20 June 2024 9 Jul 2024 1720555221
PMS Product UI Q&A Clinic (3) - 20 June 2024 10 Jul 2024 1720641625
EMA workshop on haemoglobinopathies 12 Jul 2024 1720814422
SPOR Status Update 16 Jul 2024 1721160023
ACT EU consolidated advice pilots: information and training ... 19 Jul 2024 1721419222
ESMP Essentials and Industry Reporting Requirements Webinar - 24 June 2024 19 Jul 2024 1721419222
LinkedIn live on ACT EU 24 Jul 2024 1721851223
Pack size submissions: from XEVMPD to PMS - 11 July 2024 25 Jul 2024 1721937622
PMS API Training - 8 July 2024 25 Jul 2024 1721937622
PMS Product UI and API Q&A Clinic - 23 July 2024 30 Jul 2024 1722369622
PMS Product UI & API Q&A Clinic - 16 July 30 Jul 2024 1722369622
Share Science, Achieve Breakthroughs: A Conversation with No... 31 Jul 2024 1722456023
Exploring GLP-1 receptor agonists with Dr Bart van der Schueren 8 Aug 2024 1723147222
Public System Demo Q3/2024 9 Aug 2024 1723233622
You’ve been prescribed a GLP-1. What now? Watch the full interview. 12 Aug 2024 1723492821
What should you consider as a doctor when you prescribe GLP-... 13 Aug 2024 1723579224
Is obesity a disease and what does it mean for using GLP-1s?... 20 Aug 2024 1724184022
Do you ever wonder how medicines get their name? 21 Aug 2024 1724270424
Risk Assessment Phase II - Sediment 30 Aug 2024 1725048023
Risk Assessment Phase II - Surface Water (Tier A+B) 30 Aug 2024 1725048023
Search and Evaluation of data 30 Aug 2024 1725048023
Risk Assessment Phase II: Groundwater 30 Aug 2024 1725048023
Secondary Poisoning 30 Aug 2024 1725048023
Tailored Testing Strategy 30 Aug 2024 1725048023
PBT/vPvB Assessment 30 Aug 2024 1725048023
Labelling and Risk Mitigation 30 Aug 2024 1725048023
Introduction – Scope - General Structure 30 Aug 2024 1725048023
Risk Assessment Phase I - Decision Tree 30 Aug 2024 1725048023
Risk Assessment Phase I - Decision Tree Q3 – Q7 30 Aug 2024 1725048023
Risk Assessment Phase II Sewage treatment Tier A&B 30 Aug 2024 1725048023
Risk Assessment Phase II New trigger for the soil assessment 30 Aug 2024 1725048023
Risk Assessment Phase II - Soil Exposure and Effect 30 Aug 2024 1725048023
Video 51. MRP after SPC harmonisation 19 Sep 2024 1726776021
Information session on the pilot for expert panels' advice f... 26 Sep 2024 1727380822
EMA Account Management, what's new? 30 Sep 2024 1727726422
SPOR Data Governance 11 Oct 2024 1728676824
Substance Management Service (SMS) 14 Oct 2024 1728936023
Organization Management Service (OMS) 14 Oct 2024 1728936023
Product Management Service (XEVMPD)​ for MAH 15 Oct 2024 1729022422
Product Management Service (XEVMPD)​ for Sponsors 16 Oct 2024 1729108823
Referentials Management Service (RMS) 16 Oct 2024 1729108823
How to use add package - One existing pack size 18 Oct 2024 1729281624
How to use add package - Multiple existing pack sizes 18 Oct 2024 1729281624
CAT Symposium 21 Oct 2024 1729540822
Substance, product, organization and referential (SPOR) appl... 21 Oct 2024 1729540822
One Health in Action: How EU Agencies are Tackling Environme... 22 Oct 2024 1729627224
SME Info Day 23 Oct 2024 1729713622
Training session on Human variations web-based electronic Ap... 23 Oct 2024 1729713622
L'EMA soutient l’Agence Africaine des Médicaments: améli... 25 Oct 2024 1729886423
Apoio da EMA à Agência Africana de Medicamentos: para um m... 25 Oct 2024 1729886423
EMA's support to the African Medicines Agency: improving acc... 25 Oct 2024 1729886423
EMA's support to the #AfricanMedicinesAgency: improving acce... 28 Oct 2024 1730152825
SME Info Day 30 Oct 2024 1730325626
Training webinar on Product Management Service (PMS) Product... 5 Nov 2024 1730844026
Union Product Database: how to search for notifications (NCAs, MAHs) 6 Nov 2024 1730930423
Q&A clinic on PMS Product UI and API - 22 October 2024 7 Nov 2024 1731016823
New fee regulation: webinar for industry stakeholders (human) 11 Nov 2024 1731362425
Public System Demo Q4/2024 11 Nov 2024 1731362425
New fee regulation: webinar for veterinary industry stakeholders 13 Nov 2024 1731535224
Informative webinar on PMS PUI use and key actions for Marke... 13 Nov 2024 1731535224
Q&A clinic Human variations web-based electronic Application... 13 Nov 2024 1731535224
Training on post-authorisation procedure management in IRIS ... 15 Nov 2024 1731708022
Human Variation electronic Application Form (eAF) Training a... 20 Nov 2024 1732140022
Translating Innovation into access for ATMPs 20 Nov 2024 1732140022
4th Veterinary Big Data Stakeholder Forum 20 Nov 2024 1732140022
European Shortages Monitoring Platform (ESMP) training on CA... 20 Nov 2024 1732140022
PMS Q&A Clinic - 5 Nov 2024 22 Nov 2024 1732312823
Q&A Clinic on Human Variations electronic Application Form (eAF) 22 Nov 2024 1732312823
Training on post-authorisation procedure management in IRIS ... 22 Nov 2024 1732312823
Clinical Data Publication (Policy 0070) webinar - Step 2 22 Nov 2024 1732312823
Walk in Clinic 26 Nov 2024 1732658423
EMA LinkedIn Live session on submission predictability 13 Dec 2024 1734051623
EAAD Linkedin Live recording 13 Dec 2024 1734051623
A Call to Action Against Antimicrobial Resistance - LinkedIn... 14 Dec 2024 1734138023
Q&A Clinic on Product Management Service PMS Product UI & API- 22 Nov 2024 14 Dec 2024 1734138023
PMS webinar: Submission of Manufacturers, Manufacturing Busi... 19 Dec 2024 1734570024
Q&A Clinic on post authorisation procedure management in IRIS Rec 7 Jan 2025 1736211622
EMA press briefing 16 January 2025 11 Jan 2025 1736557224
Advancing Regulatory Science Research 15 Jan 2025 1736902824
📣 #EMA has recommended two new vaccines to protect agains... 18 Jan 2025 1737162022
EMA Press Briefing: 2024 Medicine Approvals and Future Trends 21 Jan 2025 1737421224
ESMP training on crisis and MSSG-led preparedness reporting for MAHs 25 Jan 2025 1737766824
SPOR Status Update 25 Jan 2025 1737766824
European Medicines Agency's 30th Anniversary 28 Jan 2025 1738026023
What is the CVMP? 30 Jan 2025 1738198824
EMA/FVE webinar on conditions for the use certain antimicrob... 1 Feb 2025 1738371623
Q&A Clinic on post authorisation procedure management transition to IRIS 5 Feb 2025 1738717220
What's the Cancer Medicines Forum? 5 Feb 2025 1738717220
Q&A Clinic on post authorisation procedure management transi... 6 Feb 2025 1738803623
Product Management Service (PMS) webinar on Product User Interface (PUI) 7 Feb 2025 1738890024
What are Medicine Shortages? – Video Explainer 7 Feb 2025 1738890024
Q&A clinic on PMS UI & API - 4 Feb 2025 8 Feb 2025 1738976422
A Look at Medicines in 2024 | EMA Press Briefing (16 January 2025) 8 Feb 2025 1738976422
European medicines agencies network strategy (EMANS) to 2028 webinar 19 Feb 2025 1739926822
NFR Human industry Q&A clinic 20 Feb 2025 1740013220
How does DARWIN EU make health data count? - Video Explainer 21 Feb 2025 1740099622
Q&A clinic on PMS User Interface and API - 18 Feb 22 Feb 2025 1740186022
Q&A clinic on PMS User Interface and API - 13 Feb 22 Feb 2025 1740186022
NFR Veterinary Q&A clinic 25 Feb 2025 1740445222
ACT EU workshop on ICH E6 R3 - DAY 1 26 Feb 2025 1740531621
ACT EU workshop on ICH E6 R3 - DAY 2 26 Feb 2025 1740531621
Union Product Database webinar on a veterinary Industry-dedicated read-only API 6 Mar 2025 1741222826
CTIS - Bitesize talk 7 Mar 2025 1741309230
Q&A clinic for marketing authorisation holders on shortage reporting via ESMP 12 Mar 2025 1741741224
Q&A clinic on PMS User Interface and API - 25 Feb 15 Mar 2025 1742000421
On #RareDiseaseDay, a race can remind us that every step mak... 18 Mar 2025 1742259620
PMS project made easy: Summary of activities and practical t... 18 Mar 2025 1742259620
Unlocking Integration – MAH & Software Developers to explo... 20 Mar 2025 1742432420
Certificates Processing System: 1st Demo & Q&A session for industry stakeholders 20 Mar 2025 1742432420
Workshop on the challenges in drug development, regulation a... 21 Mar 2025 1742518820
EMA Veterinay Innovation Day - 14 March 2025 22 Mar 2025 1742605219
EMA Veterinay Innovation Day - 13 March 2025 22 Mar 2025 1742605219
Non mutagenic Impurities Reflection Paper Webinar 22 Mar 2025 1742605219
Public System Demo Q1/2025 22 Mar 2025 1742605219
What are Orphan Medicines? - Video explainer 25 Mar 2025 1742864419
How does EMA ensure the safety of medicines in the EU? 25 Mar 2025 1742864419
What is the CHMP? 25 Mar 2025 1742864419
EMA/FVE info session on restrictions for the use of certain ... 26 Mar 2025 1742950819
Public System Demo Q1/2025 27 Mar 2025 1743037220
Q&A clinic on PMS User Interface and API - 25 March 2 Apr 2025 1743548420
European Shortages Monitoring Platform (ESMP)- Application P... 3 Apr 2025 1743634821
3Rs Working Party 3RsWP plenary meeting - Public session on ... 9 Apr 2025 1744189216
SPOR Status Update 09/04/2025 22 Apr 2025 1745308817
Certificated Processing System 2nd Demo & Q&A session for Industry stakeholders 24 Apr 2025 1745470811
Certificates Processing System 3rd Demo & Q&A session for Industry stakeholders 25 Apr 2025 1745557211
Do you know about vaccine-preventable diseases? Stay informe... 28 Apr 2025 1745827217
EMA recommends measures to minimise risk of suicidal thought... 9 May 2025 1746766816
PMS info Day 14 May 2025 1747206016
CTIS Walk in Clinic - 14 May 2025 15 May 2025 1747306819
Măsuri pentru a reduce riscul de idei suicidare asociate cu... 28 May 2025 1748422818
PMS info Day 21 May 25 28 May 2025 1748426417
Q&A clinic on Product Management Service, User Interface and... 11 Jun 2025 1749628818
Q&A clinic on Product Management Service, User Interface and... 11 Jun 2025 1749628818
ADRA project - information session for veterinary pharmaceutical industry 17 Jun 2025 1750136419
EMA’s 30th anniversary scientific conference - Medicines, ... 17 Jun 2025 1750150817
Strengthening evidence generation in the EU 18 Jun 2025 1750248017
Public System Demo - Q2 2025 19 Jun 2025 1750316416
Q&A clinic on PMS Product User Interface (PUI) and Applicati... 1 Jul 2025 1751349619
03 Emergence of regulatory science in EU 30 years ago 4 Jul 2025 1751619618
04 A patient's perspective 30 years of regulatory and scient... 4 Jul 2025 1751619618
05 Leading the Agency through difficult times 4 Jul 2025 1751619618
06 Imagining the future of science and regulation 4 Jul 2025 1751619618
07 Are we prepared for the science of tomorrow? 4 Jul 2025 1751619618
08 How do we embrace One Health? 4 Jul 2025 1751619618
09 30 years of development in biotechnology, what's next? 4 Jul 2025 1751619618
10 From lab rats to organoids alternatives to animal testing including AI 4 Jul 2025 1751619618
11 Gender equality – women's health – the forgotten priority? 4 Jul 2025 1751619618
12 Tackling the next pandemic – yes, we can! 4 Jul 2025 1751619618
13 Final remarks 4 Jul 2025 1751619618
01 EMA's role to meet the goals of the new European Commission 4 Jul 2025 1751619618
02 From basic science to new therapies The discovery of GLP ... 4 Jul 2025 1751619618
Official opening of scientific conference 4 Jul 2025 1751626818
What were the attendees of #EMA 's 30th Anniversary Scientif... 4 Jul 2025 1751626818
Training session on Human variations web-based electronic Ap... 9 Jul 2025 1752040820
CTIS Bitesize talk 15 Jul 2025 1752577217
EU Medicines Assessment - Opportunities for expert involvement. 16 Jul 2025 1752649215
SPOR Status Update - 9 July 2025 18 Jul 2025 1752836417
ESMP updates and Q&A clinic for marketing authorisation holders (MAHs) 21 Jul 2025 1753099217
Q&A on web-based electronic Application Form (eAF) functiona... 22 Jul 2025 1753167617
Q&A clinic on Product Management Service, User Interface and... 6 Aug 2025 1754470817
Public System Demo Q3 2025 8 Aug 2025 1754629216
Darwin EU: Processing real-world health data 20 Aug 2025 1755676817
Medicine shortages in Europe 20 Aug 2025 1755676817
eAF Training Demo July 2025 2 Sep 2025 1756789220
Q&A clinic on PMS product user interface and API, 28 August 2025 2 Sep 2025 1756807218
CAT workshop on gene editing - 16 September 2025 10 Sep 2025 1757487618
Training session on Human variations web based electronic Ap... 11 Sep 2025 1757588419
Training session on Human variations web based electronic Ap... 17 Sep 2025 1758096017
Q&A Clinic on web based electronic Application Form eAF func... 7 Oct 2025 1759813219
SPOR Status Update - 8 October 2025 12 Oct 2025 1760245212
Medicine shortages and EU patients 4 Nov 2025 1762246818
Medicine shortages: how they affect nuclear medicine 4 Nov 2025 1762246818
Medicine shortages and GPs 4 Nov 2025 1762246818
Medicine shortages: what we do at EU level 4 Nov 2025 1762246818
Medicine shortages and hospital pharmacists 4 Nov 2025 1762246818
Medicine shortages and community pharmacists 4 Nov 2025 1762246818
One Health, One Planet: Our Shared Responsibility 4 Nov 2025 1762250418
Public webinar on shortages - Putting patients first 17 Nov 2025 1763366417
5th Veterinary Big Data Stakeholder Forum 18 Nov 2025 1763463618
Inside EMA – Episode 1: The drugs don’t work: Addressing... 18 Nov 2025 1763470822
Multilingual clinical trial map for EU patients 4 Dec 2025 1764831620
Clinical trial map available in all EU languages 4 Dec 2025 1764831620
Public System Demo 25Q4 4 Dec 2025 1764853220

News (46)

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2... 31 Oct 2025
ICMRA Summit 2025: EMA concludes its two mandates as chair 24 Oct 2025
EMA partners with content creators to promote safe and responsible use of GLP-1 ... 21 Oct 2025
First treatment for serious chronic lung disease 17 Oct 2025
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP... 17 Oct 2025
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 7... 10 Oct 2025
EMA Management Board: highlights of October 2025 meeting 3 Oct 2025
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2... 3 Oct 2025
Advice on end-of-year submission dates for type I variations in 2025 2 Oct 2025
A path to better include patients’ perspectives in the regulation of medicines 29 Sep 2025
New co-chairs elected for working parties for healthcare professionals and for p... 24 Sep 2025
New targets for clinical trials in Europe 23 Sep 2025
Use of paracetamol during pregnancy unchanged in the EU 23 Sep 2025
New variations guidelines to streamline lifecycle management of medicines 22 Sep 2025
First treatment recommended for rare immunoglobulin-related autoimmune disease 19 Sep 2025
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP... 19 Sep 2025
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 9... 12 Sep 2025
Management Board formally approves renewal of Executive Director’s mandate 10 Sep 2025
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1... 5 Sep 2025
Warning about sharp rise in illegal medicines sold in the EU 3 Sep 2025
EMA and WHO mark ten years of collaboration to advance global access to medicines 1 Sep 2025
EMA closed on 15 August for Assumption Day 13 Aug 2025
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP... 25 Jul 2025
First reformulation of an inhaled medicine with environmentally friendly gas pro... 25 Jul 2025
New injection for easier prevention of HIV infection in the EU and worldwide 25 Jul 2025
New treatment for Niemann-Pick type C disease 25 Jul 2025
EMA Paediatric Committee elects Sabine Scherer as its new chair 24 Jul 2025
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 1... 18 Jul 2025
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7... 11 Jul 2025
Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted 11 Jul 2025
Strengthening supply chain of anti-D immunoglobulins 4 Jul 2025
EMA starts review of sodium oxybate in alcohol dependence 20 Jun 2025
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP... 20 Jun 2025
First treatment against liver scarring caused by a type of ‘fatty liver disease’ 20 Jun 2025
EMA Management Board: highlights of June 2025 meeting 13 Jun 2025
First vaccine against swine dysentery disease recommended for approval 13 Jun 2025
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PRAC concludes eye condition NAION is a very rare side effect of semaglutide med... 13 Jun 2025

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