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Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices
Expert Insight & Answers
Patient-Centric Specification Setting: Beyond Batch Data
On-Demand Presentation by Dr. Simona Cianetti (GSK)
Regulatory science behind drug substance & drug product specifications of monoclonal antibodies
On-Demand Presentation by Dr. Patanachai “Kong” Limpikirati (Chulalongkorn University)
Synthetic-Biologics Fusion Cuisine: Innovation in Analytical Characterisation of Novel Drug Modalities
On-Demand Presentation by Dr. Bingchuan Wei, MBA (Genentech)
Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B
On-demand Presentation
Translating small-molecule development to complex generics and biosimilars
On-Demand Presentation by Dr. Joseph Glajch (JLG AP Consulting)
An Overview of Key Differences of the CMC Processes in Small-Molecule Drugs and Biotherapeutics
On-Demand Presentation by by Dr Michael Dong (MWD Consulting)
An Overview of Key Differences of Small-Molecule Drugs and Biotherapeutics: Perspectives and Quality Attributes
On-Demand Presentation by Dr. Michael Dong (MWD Consulting)
Quality Control in the (Bio)Pharmaceutical Industry: Safeguarding Medicines for Global Health
Industry Primer
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