Here's your quick look at what's coming in August 2024.

August 6, 2024: ?FDA Public Virtual Workshop to Consider Artificial Intelligence in Drug and Biological Product Development

This public workshop will convene AI experts, including drug sponsors, academia, and technology organizations, to discuss guiding principles that innovators apply to promote AI's responsible use in developing safe and effective drugs. Topics for Discussion at the Workshop

At this public workshop, the FDA plans to convene experts in AI to discuss topics including but not limited to:

• Optimizing model design through multidisciplinary expertise.
• Exploring strategies for overcoming common data-related challenges
• Balancing model performance, explainability, and transparency of AI models.
• Identify key gaps and challenges hindering the use of AI in drug and biological product development. And explore potential strategies, collaborations, and initiatives to address these challenges.

https://www.federalregister.gov/documents/2024/07/10/2024-15125/workshop-to-consider-artificial-intelligence-in-drug-and-biological-product-development-public

August 7, 2024: Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A

This is the tenth townhall in the sterilization series.? During this town hall, the FDA will host topics including bioburden, bacterial endotoxin, and packaging integrity testing for sterile medical devices.

https://www.fda.gov/medical-devices/medical-devices-news-and-events/medical-device-sterilization-town-hall-sterilization-short-topics-and-open-qa-08072024

August 21, 2024: 11th Annual UGA-FDA Medical Device Regulations Virtual Conference

Conference Objectives

To share knowledge and exchange information about the concepts of regulatory compliance to advance product quality and efficacy by assuring patient benefit.

Enable participants to gain insights into emerging regulatory trends and requirements shaping the medical device industry.

Educate attendees on navigating regulatory compliance requirements essential for medical devices in the market.

Conference Topics:

• Current medical device industry inspections and trends
• Risk-based decisions for life-cycle management medical device products
• Understanding the purpose of CAPA
• Final rule that aligns with ISO 13485 and ISO14971
• Preparing management for quality system changes
• Communicating effectively with FDA

https://www.fda.gov/about-fda/office-medical-device-and-radiological-health-operations-omdrho/ugafda-11th-annual-medical-device-regulations-conference-08212024

August 22, 2024: Webinar - In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements

This webinar is intended for laboratory manufacturers and other interested stakeholders to discuss how to comply with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files beginning May 6, 2025 (Stage 1 of the phaseout policy).

https://mdr-con.com/