Agenda

Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.

Featured Sessions

 

Lifecycle Management Considerations for C&G Therapy
Oct 14, 2024 | 1015 - 1045
Presenter: FDA
This session will illuminate the challenges and opportunities inherent in the lifecycle management of cell and gene therapy products. From initial development stages to post-market considerations, attendees will gain invaluable insights into the regulatory pathways crucial for navigating the dynamic healthcare ecosystem.
Global AI Healthcare Regulations: Trends and Future
Oct 14, 2024 | 1300 - 1330
Presenter: Attrayee Chakraborty, Northeastern University
Artificial intelligence (AI) is rapidly transforming the healthcare sector. With over 520 AI medical algorithms cleared by the FDA and a growing number of AI-enabled devices, staying ahead of regulatory trends is crucial. This session will provide in-depth insights into the regulatory landscape for AI in the medical device industry worldwide.
Regulatory Considerations on Complex APIs' Sameness
Oct 15, 2024 | 1015 - 1045
Presenter: Maotang Zhou, FDA
Navigating the regulatory landscape for complex Active Pharmaceutical Ingredients (APIs) is a significant challenge. Complex APIs, often composed of multiple components with varying molecular weights, cannot be characterized using traditional analytical techniques. The FDA recommends a comprehensive “totality-of-the-evidence” approach to assess API sameness in generic drug products.
Speakers

Selected filters:

  • Jennifer Maguire, PhD
Tue, 15 Oct
1115 – 1145

FDA Oversight of Drug Quality - Quality Surveillance

Regulatory - Compliance - Quality
Jennifer Maguire, CDER/FDA

This presentation will focus on transformative initiatives within Office of Quality Surveillance (OQS) in FDA's Center for Drug Evaluation and Research (CDER) aimed at enhancing and modernizing the agency's approach to drug quality oversight. OQS plays a pivotal role in safeguarding dug quality by leveraging various data sources and analytical methods to monitor, assess, and report on the state of drug product quality and manufacturing facilities. The OQS speaker will discuss key advancements and implementation of innovative programs that enhance FDA’s oversight of drug quality. These programs include the New Inspection Protocol Project which streamlines inspection processes; the Drug Quality Sampling and Testing Program which ensures that the drugs sold in the US meet rigorous standards; and the Quality Management Maturity Program aimed at elevating industry quality oversight. Attendees will gain insights on how these programs enhance FDA’s quality oversight and encourage continual improvement from manufacturers.

 
Jennifer Maguire
Director of the Office of Quality Surveillance
CDER/FDA

Hear From Top Industry Thought Leaders and Regulators on the Challenges and Solutions Impacting the Pharmaceutical Industry

Speaker Qualifications

Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.

Agenda Changes

Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.