"Navigating the EU Biosimilar Development Pathway"

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

WEBINAR STARTS IN

Days
Hours
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Experience,
knowledge & practice

FREE Webinar – June 6th, 2024

"Navigating the EU Biosimilar Development Pathway"

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.

Our webinar will cover

1

The definition and key characteristics of Biosimilars

2

Biosimilar
safety and interchangeability

3

The growing importance of PK/BE studies in regulatory approvals

4

Practical strategies for cost-effective and time-efficient Biosimilar development

Speakers

Anton Franken MD PhD

Anton A.M. Franken MD, PhD

SPEAKER

Consulting Physician Internal Medicine and Clinical Expert in
Drug (Biosimilar) Development, Netherlands

Michal Nowicki MD

Michal Nowicki MD, MPharm

 SPEAKER

Medical Officer and Consultant at Biokinetica
Early Phase Institute, Poland

Moderators

Ronald Koening

Ronald Koning MD, NP

MODERATOR

Chief Strategic Advisor at Biokinetica

Agnieszka Kulesza

Agnieszka Kulesza

HOST & MODERATOR

Chief Operations Officer at Biokinetica

Frequently asked questions

What is the purpose of our webinar?

Our main goal is to collect vast experience and knowledge about early phase clinical trials and share it with a broad international audience.

Our seminars are dedicated to professionals with a broad range of experience and lay audience as well. Even if you have years of experience, you will find something interesting, as we would like to focus on sharing the experience of our presenters based on real-life cases.

BIOKINETICA (EPI) is a connecting point for sponsors, CROs and Investigators. Our mission is to do Phase 1 trials, but our ambition is to deliver knowledge and experience to the public and our clients.

A discussion with the presenter is foreseen after most panels – please see the agenda.

Events

Nov 2019
Nov 2021
Apr 2024
Jun 2024
Training on early drug development
Challenges in conducting phase 1 trials in pandemic time
Are you ready for the FDA?
Navigating the EU Biosimilar Development Pathway

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