Quality Control in the (Bio)Pharmaceutical Industry: Safeguarding Medicines for Global Health
18 June 2025
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30 May 2025
Practical Examples and Regulatory Expectations for the Validation of Biotechnological Analytical Methods – Linearity Testing, Total Error Approach
On-Demand Presentation by Dr. Pierre Lebrun (Cencora – PharmaLex)
Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14
On-Demand Presentation
ICH Q2 Revision 2 and Method Development and Validation Objectives (Analytical Target Profile)
On-Demand Presentation by Dr. Joachim Ermer (Ermer Quality Consulting)
Insights on specification setting challenges and opportunities
On-Demand Presentation by Dr. Simona Cianetti (GSK)
Patient-Centric Commercial Specifications for Biotherapeutic Products, Strategies and Case studies
On-Demand Presentation by Dr Eric Rozet (GSK)
Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B
On-demand Presentation
Basic regulatory science behind drug substance & drug product specifications of monoclonal antibodies
On-Demand Presentation by Dr. Patanachai “Kong” Limpikirati (Chulalongkorn University)
Analytical Quality by Design: from Quality Target Product Profile to the Analytical Target Profile
On-Demand Presentation by Prof. Sandra Furlanetto (University of Florence)
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