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Thursday, June 27 • 9:00am - 10:15am
#403: Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-718-L04-P; CME 1.25; IACET 1.25; RN 1.25

With the advent of biosimilars on a global scale and thus the introduction of multi-source biological products, the importance of accurate pharmacovigilance and unique product traceability cannot be understated. Not only do these efforts support detection of adverse drug reactions, they give confidence to providers and patients in the safe and appropriate use of these medicines. Various approaches have been taken in attempts to facilitate unique product traceability and improve risk minimization.

This session will focus on some of these approaches and their effectiveness and will highlight the role of National Regulatory Authorities and evolving technology infrastructure to improve traceability and enable global harmonization in these approaches.

Learning Objectives

Describe the current state of pharmacovigilance efforts for biological products in various regions; Identify different approaches to unique product traceability and determine their effectiveness; Discuss how to help to identify opportunities for global harmonization to facilitate unique product identification.


Brad Jordan, PhD


Analysis of Biosimilars Approved in EU and US: Insights into Risk Minimization Strategies
Kalindi Hapani, MPharm

Biosimilars: Should They Have a ‘Similar’ System to the Originator?
Brian Edwards, DrMed

FDA Perspective
Lubna Merchant, PharmD, MS

Biologic and Biosimilar Nomenclature: How Important is Distinguishability and International Harmonization?
Philip J Schneider, MS, RPh

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 Kalindi Hapani

Kalindi Hapani

Assistant Manager, Pharmacovigilance, APCER Life Sciences
Kalindi is a Registered Pharmacist, having done Masters in Pharmacy. With stint as Lecturer for initial years (4 years in academics), she pursued Post Graduate Diploma in Clinical Research and Pharmacovigilance. She has 10 years of global experience with 6 years concentrated in pharmacovigilance... Read More →
avatar for Brad Jordan

Brad Jordan

Director, Global Regulatory and R&D Policy, Amgen
Dr. Brad Jordan is a Director of Global Regulatory and R&D Policy at Amgen where his role focuses on global technical regulatory policy relating to biologics and biosimilars. Dr. Jordan joined Amgen in 2006, and prior to his role in Policy, spent 10 years in the Discovery Research... Read More →
avatar for Lubna Merchant

Lubna Merchant

Deputy Office Director, OMEPRM, OSE, CDER, FDA
Dr. Merchant currently serves as the acting Director of the Division of Medication Error Prevention and Analysis. She is also the Deputy Director of the Office of Medication Error Prevention and Risk Management in FDA’s Center for Drug Evaluation and Research’s (CDER) where she... Read More →
avatar for Philip Schneider

Philip Schneider

Chair, Advisory Board, Alliance for Safe Biologic Medicines, United States
Philip J. Schneider is founder and principal of MediHealthInsight, which provides consultation to the industry and others on matters related to improving the use of medicines including the application of new technologies in healthcare. He is also Chair of the International Advisory... Read More →

Thursday June 27, 2019 9:00am - 10:15am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session