AGENDA 2nd MEETING

March 9, 2017 in Alexandria

  • Welcome
    Marta Sokolowska, Depomed & Karsten Lindhardt, Egalet Corp.
  • Challenges in Standardization of Cat 1 studies – Perspectives and Discussion from Last Meeting
    Karsten Lindhardt, Egalet Corp
  • Abuse Deterrent Product sameness with in vitro studies: Opportunities and challenges with FDA guidances
    Mansoor A. Khan, Texas A&M Health Science Center
  • Outcome of Hearing in Oct/Nov 2016 (How to proceed with standardization)
    Alison Fleming, Collegium and Penny Levin, Teva
  • Audience Discussion. Areas of standardization and forming working groups for a coming standardization meeting
    Panel: James Tolliver, Mansoor A. Khan, Alison Fleming, Torben Elhauge, Bob Bianchi, Sebastian Schwier, Chris Altomare
  • Can AD “equivalence” be established from Cat 1 data? Review of methods and risks
    Beatrice Setnik, INC
  • Opportunities and limits of Cat 1 data in interpretation of Human Abuse Potential Studies
    Ryan Turncliff, PRA International
  • Audience Discussion. Can “abuse deterrent Equivalence” be established in a meaningful way from in vitro data alone?
    Panel: James Tolliver, Karsten Lindhardt, Ryan Turncliff, Beatrice Setnik, Penny Levin, Ed Cone, Marta Sokolowska
  • Future Development of Abuse Deterrent Products
    Marta Sokolowska, Depome

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