2026 AQbD Symposium - Day 1 - Pharma Small Molecules
2026 AQbD Symposium Day 1 - Pharma Small Molecules
Staying ahead of regulatory change is a challenge. Evolving guidelines like ICH Q14, Q2(R2), USP <1220>, and the upcoming ICH M4Q(R2) and USP <1225> are reshaping expectations for analytical methods. Risk management and fit-for-purpose principles are now critical for compliance. Join us to explore how Analytical Quality by Design (AQbD) can help you design robust methods, streamline transfers, and meet today’s stringent small molecule and biopharmaceutical requirements.
Why Attend:
- Learn how to apply AQbD principles to the development of robust, risk-based analytical procedures.
- Use DoE tools to identify risks during method transfer and migration.
- Gain practical insights from industry experts on case studies to improve analytical testing reliability.
Session 1:
Pharma Small Molecules Presentations Practical elements from ICHQ14, Q2R2 and USP Enhanced Approach » and Practical Tools to Reduce Analytical Risks
- Gérald de Fontenay, Scientific Director, CEBIPHAR
AQbD and DOE Across Pharma Analytical Development
- Davide Messini, Analytical Development Senior/Scientist, F.I.S. - Fabbrica Italiana Sintetici S.p.A.
AQbD Approaches for GLP-1 RA Impurity Profiling
- Pawel Bigos, Senior Scientist, Waters Corporation
Presenter: Gérald de Fontenay (Directeur Scientifique et Technique, CEBIPHAR)
For more than 25 years, Gérald has held key positions within service companies (analytical CROs and CDMOs). He is currently Scientific and Technical Director at CEBIPHAR, where he ensures the highest possible reliability of the results generated both in CEBIPHAR’s laboratories and in those of its clients.
He provides his expertise in the validation, verification, and transfer of analytical methods to support CEBIPHAR’s project managers and clients, helping to accelerate the implementation of new projects at production sites and to ensure the compliance of reports.
Presenter: Davide Messini (Analytical Development Senior/Scientist, F.I.S. - Fabbrica Italiana Sintetici S.p.A.)
Degree in Chemistry (Padova). He has more than 20 years of experience in analytical chemistry in active pharmaceutical ingredients (API) manufacturing environment. He started in cGMP quality control as a QC analyst and then as R&D analyst in analytical development department. Since 2010 he is responsible for the analytical development related to the manufacturing of API (small molecules) from lab to commercial scale developing and testing all analytical methods suitable for the quality assessment of the substance. Expertise in all common instrumentation used in pharma environment, he ensures the quality of the analytical methods, analytical development strategy, robustness tests and all related cGMP aspects.
Presenter: Pawel Bigos (Senior Scientist, Waters Corporation)
Pawel Bigos is a Senior Scientist at Waters Corporation in the QA/QC Biologics group in Milford, Massachusetts. He holds a Bachelor of Science degree in Chemistry from the University of South Florida. Prior to Waters, Pawel gained valuable experience at Frequency Therapeutics, Novartis, and Symbiotic Research. Since joining Waters in 2022, he has concentrated on biomolecule separations and plays a critical role in providing analytical support in the development, commercialization, and application of Waters innovative products.
