The 2024 ISPE Annual Meeting & Expo, taking place 13-16 October in Orlando, Florida, USA, and virtually, provides a unique opportunity to hear how experts are leveraging AI/ML in the pharmaceutical industry. Learn about AI/ML resources available to help streamline workflows, optimize efforts, engage in strategic planning around these nascent/emerging technological advancements, and more. This event is crafted to equip industry professionals with insights and techniques that can help them explore and begin to plan for the effective management of digital tools, including AI and ML.
Explore AI and Digital Tools-Focused Sessions
The 2024 ISPE Annual Meeting & Expo features a variety of sessions that explore digital tools, including AI/ML, offering attendees a chance to learn more about these cutting-edge advancements:
Explore a Wide Array of AI/ML-Related Sessions
ISPE has prepared 16 AI-focused sessions for the 2024 ISPE Annual Meeting & Expo. Some key sessions are outlined below.
Delve into Digital Tools-Focused Sessions
- Uncover the possibilities: “Introduction to Digital Tools” will offer valuable insights on digital validation tools, automated testing and monitoring tools, innovative virtual reality training tools, and more
- Discover new opportunities to accelerate quality insights: In “Quality Insights from Digital Tools,” exports will outline the practical applications, benefits, and challenges of applying various digital tools to quality assurance/management in the pharmaceutical industry
- These sessions are designed to provide attendees with a foundational understanding of digital tools available for us in the pharmaceutical industry—attendees can engage with expert panels and explore real-world applications, as well as learn how to effectively navigate potential challenges
Regulatory Guidance on AI/ML Initiatives
Regulators are developing policies on AI/ML as use cases and potential applications for these new capabilities continue to evolve. Representatives from across the industry and regulatory bodies around the world, including the US Food and Drug Administration (US FDA), will be available to share insights, answer questions, and provide guidance at the 2024 ISPE Annual Meeting & Expo.
- “Responsible Use of AI in a Regulated Environment:” Secure a helpful framework for assessing AI-related risks as more formalized regulatory guidance continues to be explored and developed. Understand how to implement appropriate controls for AI/ML utilization in a pragmatic way to enable the innovative and responsible use of AI in a regulated environment
- Evolving AI Regulations on an International Scale: “Global AI Healthcare Regulations: Trends and Future” will discuss the regulatory landscape surrounding the utilization of AI in the medical device industry around the world with a focus on international initiatives—the presentation will include a discussion around the World Health Organization’s comprehensive principles governing ethical AI and will look at country-specific regulations spotlighting regulatory approaches of the EU, UK, China, India, Saudi Arabia, and more
- Engage in discussions on AI algorithms with experts and regulators: ISPE’s “Global Regulatory Town Hall: Future is Now” will address a variety of evolving topics, including AI algorithms, with questions like, “How can the industry and regulators ensure the quality, reliability, and validity of the artificial intelligence (AI) algorithms and systems that are increasingly used in the pharmaceutical sector, such as for drug discovery, clinical trials, pharmacovigilance, and manufacturing?”
ISPE Guidance on Risk Management for AI/ML Initiatives
ISPE also provides resources on effective AI/ML risk management. Digital tools and AI/ML technologies promise significant advancements. However, they also come with new challenges, highlighting the need for robust risk management frameworks. The “Machine Learning Risk and Control Framework” offers essential guidance for identifying, assessing, and mitigating AI-related risks in GxP environments, ensuring adherence to quality and regulatory standards.
Why AI and ML Risk Management Matters
Digitalization initiatives that incorporate AI and ML require a balanced approach: they are worthy of exploration but also must be approached with caution. ISPE’s Machine Learning Risk and Control Framework supports this balance by offering a dynamic approach to risk management, ensuring product integrity, patient safety, regulatory compliance, and more are upheld as AI/ML advancements are incorporated into various projects/explored as use cases.
Secure Participation
Stay at the forefront of digitalization with AI/ML and other digital tools in the pharmaceutical sector. The 2024 ISPE Annual Meeting & Expo is not just an event—it provides a platform to learn more about emerging technologies and explore potential use cases, as well as strategic approaches for implementation with experts and peers.
Register now to gain a deeper understanding of AI and ML in GxP environments. Join ISPE in Orlando, Florida, USA, or virtually to explore the future of pharmaceutical excellence through AI innovation.
ISPE members: Review the “Machine Learning Risk and Control Framework” today. ISPE also recently launched an Artificial Intelligence Community of Practice, which all ISPE members are encouraged to join.
To those who have not yet joined ISPE: Consider joining ISPE today to access resources and engage with peers on the latest insights on digitalization to drive businesses forward.
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