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Omni Shoreham Hotel

22 ene 2018 7:00 a.m. - 24 ene 2018 5:00 p.m.

2500 Calvert Street NW, , Washington, DC 20008 , USA

Pharmacovigilance and Risk Management Strategies Conference

Session 6: Clinical Trial Issues

Session Chair(s)

Annette  Stemhagen, DrPH, PhD, FISPE

Annette Stemhagen, DrPH, PhD, FISPE

Chief Science Officer

UBC, United States

The current regulatory framework and expectations for good pharmacovigilance practices are changing in key markets, which create new challenges for all stakeholders. This session will examine the expanding importance of patient perspectives on tolerability as the safety profile of an investigational product is developed. In addition, progress on global harmonization of pragmatic safety requirements will be addressed, and the impact of changes in clinical trial regulations on design of Post Authorization Safety Studies (PASS).

Speaker(s)

Sandra  Mitchell, PhD

Use of Common Toxicity AE Terminology and Patient-Reported Outcomes in Clinical Trials

Sandra Mitchell, PhD

Division of Cancer Control and Population Sciences National Cancer Institute, United States

Research Scientist & Program Director, Outcomes Research Branch

Robert M Baker

Global Harmonization of Pragmatic Safety Requirements, with Information from the Transcelerate Project

Robert M Baker

Eli Lilly and Company, United States

Deputy Chief Medical Officer

Sadiqa  Mian, MD, MPH

Speaker

Sadiqa Mian, MD, MPH

Amgen Inc., United States

Executive Medical Director, Head Safety Management

Michelle  Bulliard, BSN

Implications of the Upcoming New EU Clinical Trials Regulation on Post-Authorization Safety Studies (PASS)

Michelle Bulliard, BSN

IQVIA, Switzerland

Vice President, Global Head Real-World Evidence Strategy Unit

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