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Session 7: Non-interventional Studies: The Next Wave of Disclosure Requirements
Session Chair(s)
Erik Lakes, MS, MSc
Senior Director and Head, Data Disclosure & Transparency
Beigene, United States
This session will discuss non-interventional studies (NIS), current international disclosure requirements and the EU pharmacovigilance directive. Hear from a member of the DIA NIS Working Group and their ongoing analysis of non-interventional study requirements and posting on clinicaltrials.gov and other databases. Special focus on EU PV law and other unique disclosure requirements involving RMPs, PSURs and other related topics round out the discussion
Speaker(s)
Non-interventional Study Design and Types
Ahmed R. Saleh, PhD, MS
University of Maryland, United States
Director, Clinical Trials; Laboratory of Viral Diagnostics
Overview of International NIS Disclosure Laws and PASS Studies
Erik Lakes, MS, MSc
Beigene, United States
Senior Director and Head, Data Disclosure & Transparency
DIA NIS Working Group and ClinicalTrials.gov Database
Shannon Tyson
Pfizer Inc., United States
Manager, Clinical Trial Disclosure Group
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