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.
Filters
Selected filters:
-
Eric. Staib
Mon, 14 Oct
1015 – 1045
Digital Transformation
Brandi Stockton, The Triality Group, LLC
Eric. Staib, Syneos Health
Integration of AI brings inherent challenges that must be understood for effective digital innovation. The inherent challenges range from availability and governance of data to the need for agile development processes and organizational change management. In response to such challenges, identification of strategies and best practices is essential and should include such things as data governance frameworks, promoting diversity in both training data and development teams, adopting flexible methodologies to accommodate the iterative nature of AI. Learning to effectively implement AI involves not only technical expertise but also an organizational culture that supports experimentation and continuous improvement. This includes a cross-disciplinary approach leveraging insights from data scientists, IT, business stakeholders, and the quality organization to ensure the AI enabled technologies are aligned with objectives of the business, are ethically and responsibly integrated into operations.
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.