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Mandarin Oriental Washington D.C.

Jan 23, 2017 7:30 AM - Jan 25, 2017 3:15 PM

1330 Maryland Avenue, SW, Washington, DC 20024

Pharmacovigilance and Risk Management Strategies Conference

Round Table Luncheon Discussions

Session Chair(s)

Round Table  Discussions

Round Table Discussions

United States

There will be a 30 minute session for a limited number of participants to join roundtable discussions during the lunch break. Key thought leaders will help facilitate the discussions.

Speaker(s)

Michelle  Bulliard, BSN

Moderator: Topic #1 - PASS (Post-Authorisation Safety Studies) in Europe

Michelle Bulliard, BSN

IQVIA, Switzerland

Vice President, Global Head Real-World Evidence Strategy Unit

Keith K. Burkhart, MD

Moderator: Topic #2 - Informatic Insights into Drug Safety

Keith K. Burkhart, MD

FDA, United States

Senior Advisor for Medical Toxicology, DARS, OCP, OTS

Marsha  Millikan, RPh

Moderator: Topic #3 - Implementing the IND Safety Reporting Rule in a Global Environment

Marsha Millikan, RPh

Eli Lilly and Company, United States

Advisor, Expedited Reporting Global Patient Safety

Elizabeth E. Garrard, PharmD

Moderator: Topic #4 - Benefit-Risk: Finding the Optimal Balance

Elizabeth E. Garrard, PharmD

Clinipace Worldwide, United States

Executive Vice President, Global Safety Operations

Saad  Shakir, DrMed, MD, FFPM, FISPE, FRCP

Moderator: Topic #5 - Has the EU Pharmacovigilance Legislation Resulted in Improved Patient Safety Outcomes?

Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Drug Safety Research Unit, United Kingdom

Director

James A. Seaton

Moderator: Topic #6 - Building Better Foundations for Patient Decision-Making

James A. Seaton

Seaton Associates, LLC, United States

Executive Consultant

Mariette  Boerstoel-Streefland, MD, MBA, MS

Moderator: Topic #7 - Using the EMA Designated Medical Events List to Identify Suspected Adverse Events

Mariette Boerstoel-Streefland, MD, MBA, MS

Bristol-Myers Squibb Company, United States

Senior Vice President, Worldwide Safety Officer

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