OrBiTo Open Science Day July 1 2015

In connection with the 2015 annual OrBiTo meeting in Chilly Mazarin France, an Open Science Day is planned for the 1st of July. The Open Science Day will have a regulatory focus: “Beyond the BCS based biowaivers” and the agenda will shortly be avialable at http://www.apgi.org/


Confirmed speakers include:

Anders Lindahl (Swedish MPA), Achiel Van Peer (Janssen) et al.: Survey results from the current biopharm issues from EFPIA

Robert Lionberger (U.S. Food and Drug Administration): Impact of Modeling and Simulation on Generic Drug Development and Review

Anna Nordmark (Swedish MPA): The European regulatory perspective on the use of PBPK

Yamashita Shinji (Setsunan University, Japan): IVIVC or Quality Control?  Japanese status

Lawrence Yu (U.S. Food and Drug Administration): Title tbc.

Gordon Amidon (University of Michigan): FDA funded initiative for biorelevant dissolution – An Update

Volker Fischer: (AbbeVie, IQ Member) The Growing Impact of PBPK on Pharmaceutical Drug Development: Recipe for Success