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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Toni Manzano
Mon, 14 Oct
1115 – 1145
Process validation encompasses a lifecycle approach of three stages, from Process Design or Development, (Stage 1) through a Continued/On-going Process Verification (CPV), (Stage 3). Since Stage 3 is typically a long manufacturing phase, extensive data is accumulated, trended, and analysed there. While established conditions (EC), critical quality attributes (CQA), and critical process parameters (CPP) offer a good foundation in this work- they alone fail to provide a comprehensive depiction of the entire process including its extensive historical context. Therefore, to accomplish effective CPV implementation, it is highly recommended to incorporate process automation, Process Analytical Technologies (PAT), and a profound understanding of both the manufacturing process and drug product. To enrich data evaluation in Stage 3, statistical methodologies and multivariable analysis are now complemented with the integration of artificial intelligence (AI). AI-empowered CPV not only facilitates real-time release (RTR) and the adoption of continuous manufacturing, but also heightens the power of such concepts as the Golden Batch. Leveraging AI here expands the predictive, classifying, recognizing, and recommendation capabilities essential for continual improvement of the process, ultimately contributing to elevated product quality.
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.