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Biologicals and Biosimilars – Science versus Regulation
Session Chair(s)
Helga Gardarsdottir, PhD
Associate Professor
Utrecht University, Netherlands
Christine Hallgreen, DrSc, PhD
Associate Professor
University of Copenhagen, Denmark
This session will explore the interplay between science and regulation in the field of biologicals and biosimilars. What are the different perceptions on scientific requirements for regulatory decision-making on biosimilars? How do biological guidelines influence scientific publication of quality attributes for similarity? Are there any differences between scientific and regulatory reporting on biological safety? Three young regulatory scientists will present their most recent findings, followed by reflections from industry and academia on ways forward. The audience is encouraged to fuel the debate.
Learning Objective : Participants will be able to: - Describe the current regulatory framework for biosimilars in the EU - Differentiate different perceptions on the EU requirement for comparability clinical trials as part of establishing biosimilarity - Share their thoughts on and propose their inputs on the way forward for the EU requirement for comparability clinical trials for biosimilars
Speaker(s)
Can we go for less? Assessing perceptions of EU requirements for comparability clinical trials for biosimilars
Louise C. Druedahl, PhD, MPharm
Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), Denmark
Faculty of Law
Reporting of quality attributes in similarity assessments of (intended) biosimilars in scientific publications
Ali Mohammed Alsamil, MSc
Utrecht University, Netherlands
PhD Candidate
Safety Information of Biologicals for Multiple Sclerosis: A Comparison between Information Originating from Regulators and Scientific Safety Publications
Lotte Minnema, MPharm
Utrecht University/Medicines Evaluation Board, Netherlands
PhD candidate/pharmacovigilance assessor
Panelist
Virginia Acha, PhD, MSc
Merck Sharp & Dohme LLC, United Kingdom
AVP, Global Regulatory Policy
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