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Monday, June 19 • 11:00am - 12:15pm
#119: Designing and Implementing a Robust Pharmacovigilance System for Vaccines

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-539-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will provide insights into the distinct challenges in vaccine pharmacovigilance. Vaccine postmarketing surveillance is critical to mitigating risks, aiding in a response to vaccine safety concerns, and building public trust. The session will present the common need around the globe to manage public concerns about events related to vaccine safety. It will also discuss the differences in safety reporting requirements in vaccines in the US versus EU and the specific points to be taken into account in safety management and signal evaluation of vaccines both from the US and EU perspective.

Learning Objectives

Discuss differences in safety reporting requirements in vaccines in the US versus EU; Recognize special considerations in safety management and signal evaluation of vaccines.

Chair

Sanjeev Miglani, MD

Speaker

Special Safety Considerations in Vaccines: US Perspective
Sanjeev Miglani, MD

Active Vaccine Safety Surveillance in Low- and Middle-Income Countries
Walter Straus

GVP Module for Vaccine Pharmacovigilance
Seema Jaitly, DrMed


Moderators
avatar for Sanjeev Miglani

Sanjeev Miglani

Vice President-PV and Clinical Safety North America and Global Medical Affairs, APCER Life Sciences
Sanjeev is an MD in Internal Medicine and has more than 16 years’ experience in the field of Medicine, Pharmacovigilance and Clinical Research. He has held executive leadership positions in pharmaceutical companies and business process outsourcing firms with responsibilities fo... Read More →

Speakers
avatar for Seema Jaitly

Seema Jaitly

Managing Director, Essjay Solutions Ltd
Dr Seema Jaitly qualified in Medicine from Charing Cross and Westminster Medical School in 1992 and worked in general medicine and psychiatry for four years. She has worked in the pharmaceutical industry for over 20 years at CROs, large and small companies spanning clinical resea... Read More →
avatar for Sanjeev Miglani

Sanjeev Miglani

Vice President-PV and Clinical Safety North America and Global Medical Affairs, APCER Life Sciences
Sanjeev is an MD in Internal Medicine and has more than 16 years’ experience in the field of Medicine, Pharmacovigilance and Clinical Research. He has held executive leadership positions in pharmaceutical companies and business process outsourcing firms with responsibilities fo... Read More →
avatar for Walter Straus

Walter Straus

Associate Vice President, Therapeutic Area Head, Clinical Safety and Risk Mgmt, Merck & Co., Inc.
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologis... Read More →

Monday June 19, 2017 11:00am - 12:15pm
S401bc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  06: Safety-PV, Session