172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead

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Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products.

In this episode of Let's Combinate, host Subhi Sadeh welcomes regulatory expert Doug Mead. Doug, who brings extensive experience in regulatory affairs for medical devices and combination products, discusses the significant role of the 'Drugs at FDA' database in navigating submission strategies. They explore how AI is being used to search through this database efficiently and reveal both the benefits and limitations of AI in regulatory processes. Doug also shares insights into the evolution of FDA’s review processes, the importance of validation, and the practical application of AI in regulatory work.00:00 Welcome and Introduction00:07 Meet Doug Mead: Regulatory Expert00:58 Understanding the Drugs at FDA Database01:25 Navigating Review Memos and Regulatory Strategies04:18 Challenges and Limitations of the FDA Database07:23 Advanced Search Techniques and AI Integration10:58 Developing a Specialized AI Search Tool14:57 Practical Applications and Client Benefits33:22 Conclusion and Contact InformationDouglass(Doug) Mead is Founder of CP Pathways. He's a highly experienced combination products regulatory expert with more than 40 years of experience in large and small pharma and medical device companies. He has a diverse background in regulatory affairs for drugs and devices, including their design and testing, risk analysis, human factors testing, stability testing, and clinical trial real use patient handling assessments.www.cppathways.comSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.Artificial intelligence in Pharma, AI Pharma, AI Medical Devices, Medical Device AI