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Event
30 Sep 2015
Science

Biosimilars and Biobetters

Receive updates on recent developments in the biosimilar guideline framework and the cohesion in legislation between Europe and the US.

With Europe leading the way in the field of Biosimilar development and accounting for 80% of global spending on these molecules, the 2015 agenda will feature sessions on all areas including of product lifecycle from early stage developments, protein characterisation and analytical comparability to patent litigation, market access, pricing and reimbursement through to emerging markets and global developments.Benefits of attending:• Hear the latest on the evolving regulatory biosimilar landscape and review the guidelines • Gain understanding on the barriers being faced for market access and commercialisation of products through case-study led presentations • Focus on the global market developments with case studies on the emerging markets of biosimilars and assessing the trends we are currently seeing • Assess and review in-depth protein characterisation and analytical comparability to efficiently and effectively collect dataSpeaker Panel includes: • Chairperson: Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc • Shahin Kauser, Senior Scientific Assessor, MHRA• Chris Teale, Vice President Europe, GfK NOP Ltd• Bracha Timan, Director, Israel Site Head, Global Bioassays & Technology, Global R&D, Teva• Takashi Kei Kishimoto, Chief Scientific Officer, Selecta Biosciences• Karsten Roth, Director Clinical Operations, Cinfa Biotech GmbH• Alan Sheppard, Principal, Global Generics and Biosimilars, IMS Health• Steinar Madsen, Medical Director, Norwegian Medicines AgencyPLUS TWO HALF-DAY CONFERENCE WORKSHOPS:Assessing the Regulatory Framework for Europe and the US – Developing Future Biologics Workshop leaders: Lincoln Tsung and Daniel Kracov, Arnold & Porter (UK) LLPTuesday 29th September 2015, 1.30pm - 5.30pmBiosimilars – Understanding the Regulatory Processes and the Commercial Realities Workshop Leader: Peter Wittner, Senior Consultant, Interpharm ConsultancyFriday 2nd October 2015, 8.30am - 12.30pm

When

30 Sep 2015 @ 08:30 am

1 Oct 2015 @ 04:45 pm

Duration: 1 days, 8 hours


Where

Holiday Inn Kensington Forum

97 Cromwell Road

United Kingdom


Language

English en


Organised by

SMi Group Ltd.

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