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Omni Rancho Las Palmas Resort & Spa

Mar 19, 2018 1:00 PM - Mar 21, 2018 4:00 PM

41000 Bob Hope Drive, Rancho Mirage, CA 92270

Medical Affairs and Scientific Communications Forum

Medical Communication, MSL, and Medical Writing.

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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

Robert Paarlberg, MS

Principal

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

Speaker(s)

Deborah Collyar

Speaker

Deborah Collyar

Patient Advocates In Research (PAIR), United States

President

Mark Barnes, JD, LLM

Speaker

Mark Barnes, JD, LLM

Ropes & Gray, LLP, United States

Partner

Kelly Vaillant

Speaker

Kelly Vaillant

Vaillant Consulting, LLC, United States

President

Rebecca Williams, PharmD, MPH

Speaker

Rebecca Williams, PharmD, MPH

Essex, Part of Emmes Group, United States

Senior Clinical Trials Subject Matter Expert

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