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Monday, June 28 • 4:00pm - 5:00pm
#143 SL: A Journey of Interdisciplinary Collaboration to Improve Safety Evaluation in Drug Development

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-547-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the outputs from the DIA-ASA joint scientific working group which include an aggregate safety assessment planning tool, benefit risk assessment planning, and open source interactive graphical tools, and how to implement them.

Learning Objectives

Describe the importance of multidisciplinary collaboration; Evaluate the aggregate safety assessment planning tool; Discuss the status of benefit risk evaluation planning and how pre-marketing safety monitoring interconnects with benefit-risk evaluation; Identify open source interactive safety graphics tools with pragmatic guidance that can be easily applied to routine safety evaluation.

Chair

Mengchun Li, MD, MPA

Speaker

Aggregated Safety Assessment Planning
Barbara Hendrickson, MD

Benefit-Risk Planning Across the Industry and Best Practice Sharing
Brian Edwards, DrMed

Interactive Safety Graphics
James Buchanan, PharmD

Panelist
Lothar Tremmel, PhD


Speakers
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group, United Kingdom
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
avatar for James Buchanan

James Buchanan

President, Covilance LLC, United States
Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and... Read More →
avatar for Barbara Hendrickson

Barbara Hendrickson

Immunology Therapeutic Area Head, Pharmacovigilance and Patient Safety, AbbVie, Inc., United States
Dr. Barbara Hendrickson is the Immunology Therapeutic Area Head in Pharmacovigilance and Patient Safety. She is a physician with subspecialty training in pediatrics and infectious diseases and has 18 years of pharmaceutical industry experience. Dr. Hendrickson has been involved in... Read More →
avatar for Mengchun Li

Mengchun Li

Senior Director, Clinical Research, Infectious Disease, Merck & Co., Inc., United States
Dr. Mengchun Li is the Director of Pharmacovigilance at TB Alliance. In this position, Dr. Li chairs the multidisciplinary safety management team for all compounds and is responsible for clinical safety and pharmacovigilance. Prior to this, Dr. Li worked at Janssen Pharmaceutical... Read More →
avatar for Lothar Tremmel

Lothar Tremmel

VP, Quantitative Clinical Sciences and Reporting, CSL Behring, United States
Dr. Tremmel worked in the pharmaceutical industry for over 25 years, where he built and led highly effective groups of statisticians, programmers, and data managers. He is currently the VP of Quantitative Clinical Sciences and Reporting at CSL Behring. Recent appointments include... Read More →

Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  11: Statistics, Session |   01: ClinSafety-PV, Session