Documents ⇽ 2023 PDA Asia Pacific Regulatory Conference | Parenteral Drug Association on Glue Up

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download Day 1-Opening Plenary: National CGT Manufacturing Blueprint | Marguerite Evans Galea
download Day 1-Session 1: Feedback from the Industry on the Implementation of Annex 1 | Richard Denk
download Day 1-Session 2: EU Medical Device Regulation (MDR) vs US FDA Requirements for Devices in Sterile Combination Products | Daniel Flewellen
download Day 1-Session 2: Current GMP Requirements for Combination Products | Peter Qiu
download Day 1-Session 2: Case Study: Regulatory Challenges and Opportunities in Developing a Novel Microarray Patch Delivery System | Kerrie Way
download Day 1-Session 3: Points to Consider for the Commercial Manufacturing of ATMPs | Richard Denk
download Day 1-Session 3: Cell and Gene Therapy Market and Regulatory Trends | Juliana Gutierrez
download Day 2-Session 4: Quality Management Maturity (QMM) | Peter Qiu
download Day 2-Session 4: Points to Consider for the Implementation of ICHQ12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management | Bruce Loxley
download Day 2-Session 5: AI and Parenteral Products - What Does This Look Like and How is PDA Supporting Industry | Lisa Bennett
download Day 2-Session 5: AI in the Regulatory Space | Ben Stevens
download Day 2-Session 5: Case Study: Artificial Intelligence for Environmental Monitoring | Julie Winson
download Day 2-Session 5: The Impact of Large Language Models (LLMs) on Quality Management Systems in Biotech, Medtech and Pharma Industries | Piper O’Keeffe, Connor White
download Day 2-Session 6: Considerations and Challenges Associated with Developing Phase-Appropriate Stability Programs for Investigational Medicinal Products | Dean Whelan
download Day 2-Session 6: Case Study: Phase I Drug Product through Analytical Testing | Patrick James
download Day 2-Session 7: Updates on FDA/CDER’s Inspection Program Post-Pandemic | Peter Qiu
download Day 2-Session 7: CDMO Compliance: A Case Study from Samsung Bioepis | Chris KwangYong Nam
download Day 1-Keynote Speech: Update from PIC/S | Jenny Burnett

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