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.
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Chris Musteikis
Mon, 14 Oct
1400 – 1430
Sustainability - Supply Chain Resiliency
Chris Musteikis, Gsk
How do differences in global requirements and filing timelines lead to drug shortages?
This session will compare the regulatory requirements and review timelines in several global markets spanning the US, EU and several Asia-Pacific markets, outline a case study to demonstrate true-to-life consequences, and propose regulatory solutions. Extensive requirements and long review timelines can discourage the global implementation of new technologies or process/method improvements, and can delay critical updates of suppliers or manufacturing sites that can sustain drug supply. These delays can mean new medicines aren’t available to patients globally, and that products that are already on the market are at risk of drug shortage. Looking forward, there may be reliance models that global regulatory agencies could adapt that could ease the reviewers’ burdens, accelerate review, and reduce drug shortages.
This session will compare the regulatory requirements and review timelines in several global markets spanning the US, EU and several Asia-Pacific markets, outline a case study to demonstrate true-to-life consequences, and propose regulatory solutions. Extensive requirements and long review timelines can discourage the global implementation of new technologies or process/method improvements, and can delay critical updates of suppliers or manufacturing sites that can sustain drug supply. These delays can mean new medicines aren’t available to patients globally, and that products that are already on the market are at risk of drug shortage. Looking forward, there may be reliance models that global regulatory agencies could adapt that could ease the reviewers’ burdens, accelerate review, and reduce drug shortages.
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.