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

EXPERT FORUM

Your registration was successful, so you can now watch and attend the on-demand presentation.

If you know a colleague who would benefit from this presentation, use the form to invite them.

After watching the presentation(s), please take a moment to share your extremely valuable insights. It will only take a few minutes.

Start the Survey

ICH Q2 Revision 2 and Method Development and Validation Objectives (Analytical Target Profile)Presentation by Dr. Joachim Ermer

Part 1: Understanding the ICH Q2 GuidelineExpert Forum Panel Discussion

Practical Examples and Regulatory Expectations for the Validation of Biotechnological Analytical Methods - Linearity Testing, Total Error ApproachPresentation by Dr. Pierre Lebrun

Part 2: Key Challenges and Solutions in Adapting to ICH Q2(R2)Expert Forum Panel Discussion

Presenters / Panellists

Dr. Joachim Ermer Founder & Owner Ermer Quality Consulting (Germany) Since December 2020, Dr. Ermer has provided consulting and training on pharmaceutical analysis and Quality Control topics. He studied biochemistry and has 30 years of experience in pharmaceutical analytics, including global responsibilities as Director of Analytical Processes and Technology, Head of Quality Control, and Head of QC Lifecycle Management (Sanofi, Frankfurt), as well as Sanofi Global Reference Standard Coordinator. He is a member of the USP Expert Committee “Measurement and Data Quality" and the Ph. Eur. Chromatographic Separation Techniques Working Party. Dr. Ermer frequently speaks at national and international conferences, with over 200 presentations, courses, and workshops. He has authored more than 70 publications on analytical topics. He is the editor and author of three editions of the book “Method Validation in Pharmaceutical Analysis: A Guide to Best Practice” (Wiley-VCH, 2005, 2015, and 2025).

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

Moderators

Prof. Dr. Cari Sänger-van de Griend Scientific Director BioQC 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 Scientific Director BioQC 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.

Brought to you by:

Ask a Question

Join the conversation (or start a discussion) on the BioQC User Community.

Contact Us

If you have any questions about the event, don’t hesitate to get in touch with the BioQC Team: Feedback & General Enquiry