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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.
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Maotang Zhou
Tue, 15 Oct
1015 – 1045
Regulatory - Compliance - Quality
Maotang Zhou, FDA
As part of the abbreviated new drug application (ANDA) evaluation, FDA recommends applicants fully understand the potential for changes in or to the active ingredient during the manufacturing process. Complex APIs are often mixtures of different components and can contain a distribution of molecular weight. Due to their complexity in both composition and structure, complex APIs cannot be characterized by typical analytical techniques. To demonstrate the sameness of a complex API in a generic drug product, a “totality-of-the-evidence” approach is generally employed during regulatory assessment. This approach includes three key components: manufacturing process understanding, orthogonal characterization, and comparative biological activity analysis, if necessary. Unlike well-defined small molecule APIs, manufacturing processes are especially critical in ensuring the consistency of composition and properties for complex APIs. This presentation will provide an overview of key regulatory considerations on demonstrating complex API sameness. We will focus on unique aspects of complex API manufacturing processes and facility inspection data, including data obtained through remote regulatory assessments (RRAs). Additionally, we will present regulatory resources that are available to facilitate the development of complex generic drug products containing complex APIs.
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.