Zapraszamy na bezpłatny Webinar pt. "Navigating the EU Biosimilar Development Pathway".

Eksperci leków biopodobnych – Anton A.M. Franken MD, PhD oraz Michal Nowicki MD, MPharm

- przybliżą podstawy naukowe, bezpieczeństwo, wymienność i najnowsze trendy w środowisku regulacyjnym.

Szerokie spojrzenie na temat podczas godzinnego spotkania na żywo.

Zarezerwujcie czas w czwartek 6 czerwca o 16:00.

Rejestracja https://biokinetica.com/en/current-event/

"Navigating the EU Biosimilar Development Pathway" [FREE WEBINAR]

The changing regulatory landscape, its impact on clinical development, and practical strategies for success in a Phase I unit.

June 6th, 2024, 4:00-5:00 PM CET

This webinar will provide an in-depth overview of biosimilars, including their scientific background, safety, interchangeability, and the latest views on the rapidly changing regulatory landscape.

We will explore how to prepare for the future regulatory focus on PK bioequivalence studies, rather than patient comparative efficacy studies, as the core of the regulatory dossier. What are the clinical implications of this shift?

How can we support future biosimilar development in a cost-effective and time-efficient manner?

This free webinar, sponsored by Biokinetica Early Phase Institute, will combine science, regulatory updates and practical clinical implications. It is designed for anyone involved in biosimilar drug development, including professionals in pharmaceutical/biotech companies and CROs, or those who are looking to start their journey in this area.

Join our free webinar to learn about the latest developments in biosimilars.

This webinar will provide you with a clear overview of biosimilars, including their scientific background, safety, interchangeability, and the current regulatory landscape. You’ll learn the key issues driving this important area of drug development.

SPEAKER

Anton A.M. Franken MD, PhD

Consulting Physician Internal Medicine and Clinical Expert in

Drug (Biosimilar) Development, Netherlands

SPEAKER

Michal Nowicki MD, MPharm

Medical Officer and Consultant at Biokinetica

Early Phase Institute, Poland