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Wednesday, June 21 • 4:00pm - 5:15pm
#376: Changing Environments Within Pharmacovigilance

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-538-L04-P; CME 1.25; IACET 1.25; RN 1.25

Updates in pharmacovigilance and safety in various markets with changing regulatory environments. Speakers will include: FDA, EMA, as well as other key regions such as Japan, China, and emerging markets like Africa.

Learning Objectives

Discuss changes in regional and global regulations and how they impact one's pharmacovigilance organization.

Chair

Stella C.F. Blackburn

Speaker

Navigating Through the World of Combination Product Safety
Khaudeja Bano, MD, MS

Regulatory Scientific Significance of Japan’s Postmarketing Adverse Event Relief System
Toshiyoshi Tominaga, PhD

Overview of Changes to the FDA Pharmacovigilance Regulatory Landscape
LaShanda Long, MS


Moderators
avatar for Stella Blackburn

Stella Blackburn

Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of... Read More →

Speakers
avatar for Khaudeja Bano

Khaudeja Bano

Senior Medical Director, Medical Affairs, Diagnostics, Abbott Laboratories
Khaudeja is a Physician with Masters in Clinical Research, Pharmaceutical Engineering Certification, a DBA, and a certified Project Management Professional. She is an avid Toastmaster and a certified coach. Khaudeja has 25 years of professional experience, including clinical practice... Read More →
LL

LaShanda Long

Supervisor, Office of Scientific Investigations, OC, CDER, FDA
LaShanda Long is the branch chief of the Postmarketing Safety Branch (PSB) in the Office of Scientific Investigations, CDER, FDA. PSB monitors adherence to regulations and statutes governing postmarketing adverse drug experience reporting requirements, Risk Evaluation and Mitigation... Read More →
avatar for Toshiyoshi Tominaga

Toshiyoshi Tominaga

Associate Executive Director (for International Programs), Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he... Read More →

Wednesday June 21, 2017 4:00pm - 5:15pm
S404d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  06: Safety-PV, Session