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RAI Center

Mar 04, 2013 9:00 AM - Mar 06, 2013 5:30 PM

Europaplein, 1078 GZ Amsterdam, Netherlands

25th Annual EuroMeeting

BIOSIMILARS: DEVELOPING A MORE THOROUGH UNDERSTANDING OF A KNOWN ACTIVE SUBSTANCE

Session Chair(s)

Virginia  Acha, PhD, MSc

Virginia Acha, PhD, MSc

AVP, Global Regulatory Policy

Merck Sharp & Dohme LLC, United Kingdom

Just when you thought you knew all you needed to know about known actives, the rapidly developing field of biosimilars is presenting new challenges and opportunities. Taken from three perspectives, this session will address how establishing biosimilarity advances our understanding of known actives. Ironically, this is done whilst biosimilars themselves are not well understood by key stakeholders, such as physicians, patients and the wider public. Each of the presenters will discuss these points, reflecting on key developments and initiatives underway in both the regulatory and policy arenas in Europe.

Speaker(s)

Christian  Schneider, DrMed

Biosimilarity: A better definition of terms and concepts

Christian Schneider, DrMed

PharmaLex, Denmark

Head of Biopharma Excellence and Chief Medical Officer (Biopharma)

Mark  McCamish, MEd, PMP

Mark McCamish, MEd, PMP

Forty Seven Inc., United States

President and Chief Executive Officer

Virginia  Acha, PhD, MSc

Trust through Engagement: Explaining biosimilarity to a wider audience

Virginia Acha, PhD, MSc

Merck Sharp & Dohme LLC, United Kingdom

AVP, Global Regulatory Policy

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