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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)
Speaker
Deborah Collyar
Patient Advocates In Research (PAIR), United States
President
Speaker
Mark Barnes, JD, LLM
Ropes & Gray, LLP, United States
Partner
Speaker
Kelly Vaillant
Vaillant Consulting, LLC, United States
President
Speaker
Rebecca Williams, PharmD, MPH
Essex, Part of Emmes Group, United States
Senior Clinical Trials Subject Matter Expert