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Session 8 Track 2B: Brave New World: Planning for Global Submissions in a Post-Disclosure World
Session Chair(s)
Robert Paarlberg, MS
Principal, Paarlberg & Associates LLC, United States
Learning Objective : At the conclusion of this session, participants should be able to:- Identify key areas within a company impacted by the ClinicalTrials.gov Final Rule and EMA Policy 0070
- Describe how disclosure/transparency requirements are impacting approaches to protocol and clinical study report writing
- Discuss potential legal implications that disclosure is having in the US and EU
- Describe how disclosure/transparency is impacting orphan/rare disease community
Speaker(s)
Deborah Collyar
President, Patient Advocates In Research (PAIR), United States
Speaker
Mark Barnes, JD, LLM
Partner, Ropes & Gray, LLP, United States
Speaker
Kelly Vaillant
President, Vaillant Consulting, LLC, United States
Speaker
Rebecca Williams, PharmD, MPH
Senior Clinical Trials Subject Matter Expert, Essex Management, Part of Emmes Group, United States
Speaker
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