Best Practices for Updating Analytical Procedures in Drug Development and Manufacturing
On-Demand Presentation
Quality Control in the (Bio)Pharmaceutical Industry: Safeguarding Medicines for Global Health
Industry Primer
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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)
Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices
Expert Insight & Answers
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
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