5th FDA/PQRI Conference on Advancing Product Quality: Advancing Quality & Technology of Future Pharmaceuticals
Conference Overview
On December 1 – 3, 2021, FDA and PQRI hosted a virtual public Conference, the 5th FDA/PQRI Conference on Advancing Product Quality: Advancing Quality & Technology of Future Pharmaceuticals. This Conference brought together leaders from regulatory agencies, industry experts, and academia to discuss key, critical topics in drug product delivery. Input from attendees will aid in future FDA guidance development. Each day focused on a different theme and included a Hot Topic discussion:
Day 1: Biopharmaceutics: Biopharmaceutical Considerations for Product Design and Development
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- Development of robust pharmaceutical products requires comprehensive/orthogonal evaluation of the link between critical quality attributes (e.g., dissolution, release) and absorption properties along with the use of computational tools to predict in vivo performance. The judicious use of physiological based pharmacokinetic modelling and simulation (PBPK) along with patient-centric approaches for drug product development is essential to the delivery of transformative therapies. Hot Topic: Biopharmaceutics for mRNA and Nano-Drug Delivery.
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Day 2: Development— New Horizons for Pharmaceutical Development
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- The future direction of pharmaceutical development for small and large molecule drug products has been profoundly influenced by recent events and technological advances. Prominent on the horizon are emerging modalities for novel therapeutics, and innovative approaches for applying knowledge and data to expedite meaningful decision-making. This track will explore opportunities and challenges represented by these areas, superimposed on a landscape of rapidly evolving industry practice and regulatory expectations. Hot Topic: Experience with Emergency Use Authorizations and Accelerated Development
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Day 3: Product Quality— Innovation in Quality & Technology Beyond the Pandemic
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- In a post-pandemic world, developing agile and innovative solutions that adapt to the pace of change is critical for all aspects of the pharmaceutical product lifecycle including regulatory, manufacturing, and quality. This Track will explore current developments in modernization of regulatory submissions, in advanced manufacturing, and in remote site evaluations which are each evolving in real-time to address these future challenges. Hot Topic: Remote Interactive Evaluations (RIEs)
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Conference Materials
The Final Program can be downloaded by clicking on the icon below.
Thank you to our Sponsors! |
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QUESTIONS
Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5607 or PQRISecretariat@pqri.org.