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Wednesday, June 26 • 2:00pm - 3:15pm
#370: Challenges and Opportunities in Product Quality: Lifecycle Management

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-699-L04-P; CME 1.25; IACET 1.25; RN 1.25

The efficacy and safety of a drug product are linked to its quality. Assuring product quality across the product lifecycle is challenging due to the numerous changes made to maintain or enhance product quality and manufacturing efficiency. Regulatory and industry speakers in this session will describe current thinking on product quality lifecycle management.

Learning Objectives

Describe FDA's current thinking on drug product quality lifecycle management, from brand name drugs to generics; Discuss specific tools and mechanisms in efficiently managing product lifecycle: Identify existing and upcoming regulatory tools to ease post approval changes.

Chair

Susan M. Rosencrance, PhD

Speaker

Lifecycle Management Challenges for Accelerated Program and Possible Innovative Solutions
Lucy Chang, PhD

Opportunities for Streamlining Postapproval Lifecycle Management Under ICH Q12
Isabelle Colmagne-Poulard, PharmD, MBA, MSc

Challenges and Opportunities in Lifecycle Management of Product Quality
Hasmukh B. Patel, PhD


Speakers
avatar for Isabelle Colmagne-Poulard

Isabelle Colmagne-Poulard

Head, International Global Regulatory Affairs & Scientific Policy, Merck KGaA, Switzerland
Isabelle has joined Merck Serono since 2005 where she has held growing managerial roles in RA and RA CMC as Head of Department. She is actively engaged in international regulatory policy as member of IFPMA Biotherapeutics WG and IFPMA Regulatory Strategy Committee since 2015. She... Read More →
avatar for Susan Rosencrance

Susan Rosencrance

Acting Director, Office of Generic Drugs, CDER, FDA, United States
Susan Rosencrance, Ph.D., serves as the Acting Director of the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER). From 2015 to 2022, Dr. Rosencrance served as the Director of the Office of Lifecycle Drug Products within CDER’s Office of Pharmaceutical... Read More →
avatar for Lucy Chang

Lucy Chang

Exceutive Director, Merck & Co., Inc.
Dr. Chang received her Ph.D. from University of Connecticut and has worked in various biopharm companies including Sanofi, GSK, Pfizer and Teva. She is currently the Executive Director of Global Regulatory CMC, providing regulatory leadership, oversight and strategy to a team of Regulatory... Read More →
avatar for Hasmukh Patel

Hasmukh Patel

Director, OLDP, OPQ, CDER, FDA, United States
Dr. Hasmukh Patel is the Division Director in the Division of Post-Marketing Activities 1 (for NDAs) in the Office of Lifecycle Drug Products (OLDP), OPQ, CDER. He is with the FDA for more than 20 years. Pharmaceutical Science (OPS). Dr. Patel has extensive technical, regulatory and... Read More →

Wednesday June 26, 2019 2:00pm - 3:15pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session