This event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry. This comprehensive overview will help attendees understand the changing global market and the challenges faced within the industry.
This year’s agenda includes the following:
New digital technology trends and evaluation of connectivity.
- Regulatory Processes and Challenges, including home-based administration and compliance within a fast-changing landscape.
- 21st century cures act and evaluation of article 117
- Innovative designs and drug delivery systems including device combination product challenges.
- The future of PFS, next generation syringes, biologics and addressing the emerging challenges of chemical compatibility.
- Interactive panel discussions led by industry experts.
- Development within injectables translated into device management.
SPEAKERS INCLUDE:
CHAIRS:
Dhairya Mehta, Director Device and Combination Products, Shire
Darin Oppenheimer, Executive Director, Head Drug Device Centre of Excellence, Merck
SPEAKERS:
Molly Story, Head of Global Usability Engineering and Risk Management, Sanofi
Linda Ricci, Associate Director for Digital Health, Office of Device Evaluation, FDA
Nicholas Zampa, Senior Engineer, Human Factors and Risk Management, Biogen
John Schalago, Head Devices, EMD Serono
Cedric Gysel, Health Care Solutions Design Manager, Johnson & Johnson Design
Joyce Y Zhao, Device Lead, Combination Product Development, Takeda
Michael Song, Sr. Manager, Drug Delivery and Device Development, MedImmune
Amit Khanolkar, Director, New Product Development Quality Engineering, Janssen
Ramin Samadani, Senior Scientist in Dosage, Form, Design and Development, MedImmune
Hemal Mehta, Associate Director Global CMC RA, Medical Devices and Combination Products, Janssen
Ling Lu, Sr. Principal Scientist, Pfizer
Brian Frank Lewis, Senior Consultant Engineer, Eli Lilly
Tina Kiang, Acting Division Director, CDRH/ODE/DAGRID, FDA
EARLY-BIRD RATES:
BOOK BY 28 FEBRUARY AND SAVE $100
8 Apr 2019 @ 08:30 am
9 Apr 2019 @ 05:50 pm
Duration: 1 days, 9 hours
Sheraton Boston Hotel
39 Dalton Street
MA 02199 Boston
United States
English en