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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Attrayee Chakraborty
Mon, 14 Oct
1300 – 1330
Regulatory - Compliance - Quality
Attrayee Chakraborty, Northeastern University
Artificial intelligence (AI) has disrupted almost every sector, including that of healthcare. As of December 2023, the FDA has cleared more than 520 artificial intelligence (AI) medical algorithms since 1995, with 171 AI-enabled medical devices added to the list in 2023. However, international harmonization on AI is far from achievable currently.
I will delve into the regulatory landscape surrounding the utilization of AI in the medical device industry across the globe, offering insights into the diverse philosophies shaping such regulations. The primary emphasis is on examining international initiatives, notably the WHO's comprehensive principles governing ethical AI and its regulatory frameworks and also conduct an in-depth exploration of country-specific regulations, spotlighting the regulatory approaches of the EU, UK, China, India and Saudi Arabia while also providing an overview of emerging regulations in Japan and Italy. I will also focus on how to validate and build reliance on AI systems used internally within companies through risk-based methodologies to effectively use AI solutions in the workplace.
I will delve into the regulatory landscape surrounding the utilization of AI in the medical device industry across the globe, offering insights into the diverse philosophies shaping such regulations. The primary emphasis is on examining international initiatives, notably the WHO's comprehensive principles governing ethical AI and its regulatory frameworks and also conduct an in-depth exploration of country-specific regulations, spotlighting the regulatory approaches of the EU, UK, China, India and Saudi Arabia while also providing an overview of emerging regulations in Japan and Italy. I will also focus on how to validate and build reliance on AI systems used internally within companies through risk-based methodologies to effectively use AI solutions in the workplace.
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.