Expert Forum
Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B
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Part 1: Overview of ICH Q6B guideline and current practice on specification settings
Overview of the ICH Q6B Guideline - Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics by Dr. Patanachai “Kong” Limpikirati
Part 1: Overview of ICH Q6B guideline and current practice on specification settings
Expert Forum Panel Discussion
Part 2: ICH Q6B & challenges in setting patient-centric specifications
Patient-Centric Commercial Specificaons for Biotherapeutic Products, Strategies and Case studies by Dr. Eric Rozet
Part 2: ICH Q6B & challenges in setting patient-centric specifications
Insights on specification setting challenges and opportunities by Dr. Simona Cianetti
Part 2: ICH Q6B & challenges in setting patient-centric specifications
Expert Forum Panel Discussion
Presenters / Panellists
Dr. Patanachai “Kong” Limpikirati
Lecturer, Department of Food and Pharmaceutical Chemistry
Faculty of Pharmaceutical Sciences, Chulalongkorn University (Thailand)
Dr. Eric Rozet
Lead Statistician
GSK (Belgium)
Dr. Simona Cianetti
Senior Director, Head CMC Analytical Projects, Portfolio and Technology Delivery
GSK (Italy)
Carmilia Jiménez Ramírez, Ph.D.
President & Chief Consultant
Miliar Biopharma Solutions (USA)
Moderators
Prof. Dr. Cari Sänger-van de Griend
Expert in (bio)pharmaceutical analytical chemistry with 30 years of industrial and academic experience in method development and control strategies, including Analytical Quality by Design (AQbD), and focused on best practices and knowledge sharing.
Dr. Ewoud van Tricht
Expert in (bio)pharmaceutical analysis with over 18 years of industrial experience in analytical development, Quality Control, and Analytical Quality by Design (AQbD). He has contributed to diverse therapeutic modalities, including small molecules, viruses, and cells, at leading companies such as Janssen Vaccines and Sanofi Cell Therapy.
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Resources
[GUIDELINE]
Specifications: Test Procedures And Acceptance Criteria For Biotechnological/Biological Products Q6b
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