EXPERT FORUM

Addressing Challenges in Analytical Validation: Understanding ICH Q2(R2) and Integration with ICH Q14

Part 1:  Understanding the ICH Q2 Guideline (21 May, 2025)
Part 2: Key Challenges and Solutions in Adapting to ICH Q2(R2) (28 May, 2025)  

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Presenters / Panellists

Dr. Joachim Ermer

Dr. Joachim Ermer
Founder & Owner
Ermer Quality Consulting (Germany)

Dr. Pierre Lebrun

Dr. Pierre Lebrun
Director, Principal Consultant, Data Strategy and Quantitative Sciences
Cencora – PharmaLex (Belgium)

Moderators

Prof. Dr. Cari Sänger-van de Griend

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

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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