Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D1 – Part 4

This symposium, held every two years, explored topics related to pharmaceutical quality regulation, supply chains, and advanced manufacturing technologies.

Timestamps

00:01 – Overview of Policy Document Options, Development, and Oversight

17:28 – International Harmonization: Ensuring Availability of Quality Medicine

27:57 – ICH Q12 Implementation: What Does Industry Need to Know

01:10:04 – Nitrosamine Research Studies Inform FDA on Potential Strategies and BE Approaches

01:25:32 – USP & FDA: A Symbiotic Relationship to Ensure Quality

01:42:01 – Not So Complex? Product-Specific Guidance Updates

01:53:53 – Q&A Discussion Panel

02:14:19 – Day One Closing

Speakers | Panelists:

Leila Wieser
Director | Editorial and Project Management Staff
Office of Policy for Pharmaceutical Quality (OPPQ)
Office of Pharmaceutical Quality (OPQ) | CDER

Theresa Mullin, PhD
Associate Director for Strategic Initiatives
CDER

Mahesh Ramanadham, PharmD, MBA
CDR | USPHS
Deputy Director
OPPQ | OPQ | CDER

Dongmei Lu, PhD
Pharmacologist
OPPQ | OPQ | CDER

Pallavi Nithyanandan, PhD
Director
OPPQ | OPQ | CDER

Xiaoming Xu, PhD
Division Director
Office of Testing and Research (OTR)
OPQ | CDER

Adam Fisher, PhD
Director of Science Staff
OPQ | CDER

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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