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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.


Susan M. Rosencrance, PhD


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

avatar for Isabelle Colmagne-Poulard

Isabelle Colmagne-Poulard

Senior Director, Regulatory CMC, GRA and Quality Assurance, Merck Serono
Isabelle has joined Merck Serono since 2005 where she held growing managerial roles in RA and RA CMC as Head of Department. She is actively involved in regulatory CMC intelligence as member of IFPMA Biotherapeutics WG and IFPMA Regulatory Strategy Committee since 2015. She takes part... Read More →
avatar for Susan Rosencrance

Susan Rosencrance

Director, Office of Lifecycle Drug Products, OPQ, CDER, FDA
Dr. Susan Rosencrance presently heads FDA's Office of Lifecycle Drug Products within the Office of Pharmaceutical Quality (OPQ). She provides executive leadership by overseeing and directing scientific review programs and activities related to evaluating drug product quality throughout... 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 of Division of Post-Marketing Activities I, OLDP, OPQ, CDER, FDA
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. Dr. Patel has extensive technical, regulatory and managerial experience. His... 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