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Session 7: Challenges and Opportunities in Post Marketing Pharmacovigilance and Lifecycle Management for Complex Generic Drug-Device Combination Products
Session Chair(s)
Karen Feibus, DrMed, MD
Lead Medical Officer, Drug-Device Combination Team, Division of Therapeutic Perf
FDA, United States
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States
Complex generic drug/device combination products offer new therapeutic access and opportunity but also bring new challenges. Issues related to lifecycle management of product safety and therapeutic equivalence affect drug developers, drug regulators, healthcare providers, and patients. During this session, CDER representatives will discuss methods to monitor combination generic drug pharmacovigilance and to identify post-market safety issues through evaluation of medication errors and human factors considerations. The Office of Combination Products will discuss implementation of recent regulatory changes in post-marketing safety reporting requirements for combination products. Post-marketing changes to the drug or device constituent parts or manufacturing processes can pose unique review challenges. A generic drug industry representative will explore the importance of promoting a culture of safety reporting compliance and building a product safety lifecycle management infrastructure. Time is included for open discussion and dialogue.
Learning Objective : At the conclusion of this session, participants should be able to:
- Differentiate among the roles played by OGD, OCP, and OSE’s Division of Medication Errors and Prevention Analysis in evaluating post-marketing safety concerns
- Describe human factors and medication error considerations in evaluating post-market safety issues throughout the product lifecycle
- Explain how FDA determines whether post-marketing changes impacts quality attributes
Speaker(s)
Combination Product Post-marketing Safety Reporting Requirements and Implementation Update
Melissa Burns, MS
FDA, United States
Senior Program Manager, Office of Combination Products, OCPP, OC
Complex Generic Drug-Device Product Safety Surveillance and Data Analytics
Jung Lee, MPH, RPh
FDA, United States
Data Scientist, Division of Clinical Safety and Surveillance, OGD, CDER, FDA
Human Factors and Medication Error Considerations in Evaluating Post-Market Safety Issues for Generic
Millie B. Shah, PharmD
FDA, United States
Human Factors Team Leader, DMEPA, OSE, CDER
Post-market ANDA Quality Supplement Review for Drug-Device Combination Products
Jianxin (Jason) Yang, PhD
FDA, United States
Chemist/Quality Assessor, Office of Life Cycle Drug Products, OPQ, CDER
Industry Collaboration to Ensure Lifecycle Management Best Practices for Complex Generic Combination Products
Karthik Balasubramanian, PhD, MS
Verrica Pharmaceuticals, United States
VIce President, CMC & Technical Operations
Industry Collaboration to Ensure Lifecycle Management Best Practices for Complex Generic Combination Products
James Wabby, MHS
AbbVie, United States
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
Panel Discussion
All Session Speakers, United States
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