Medical Affairs and Scientific Communications Forum
Medical Communication, MSL, and Medical Writing.
Session 8 Track 2B: Brave New World: Planning for Global Submissions in a Post-Disclosure World
Robert Paarlberg, MS
Paarlberg & Associates LLC, United States
Clinical trial disclosure requirements of the ClinicalTrials.gov Final Rule and EMA’s proactive publication of clinical data under Policy 0070 are having a significant impact on company processes and strategies. This session will be a panel discussion on hot topics in clinical trial disclosure/transparency and how they are impacting company processes and strategies as well as impact on the orphan/rare disease community. Topics to be addressed include: how disclosure requirements are impacting clinical development strategies; commercial confidential information; individual personal data; potential legal implications to patients and companies; and impact on the orphan/rare disease community.
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
Deborah E. Collyar
Patient Advocates In Research (PAIR), United States
Mark Barnes, JD
Ropes & Gray, LLP, United States
Global Head, Clinical Trial Disclosures & Data Transparency