Regulatory Strategy in a Transforming Landscape
Webcode 26112630
Dr. Karsten Roth
Polpharma Biologics International, SWITZERLAND
Head of Clinical Development; Karsten Roth is a development professional with 30 years’ experience. For the last 6 years he leads the clinical development activities at Polpharma Biologics International overseeing the biopharmaceutical and Biosimilar development programs. In addition to his responsibilities at Polpharma Biologics, he is the Vice-Chair of the Biosimilar Medicines Group, at Medicines for Europe in Brussels, Belgium representing several global companies of the Biosimilar sector.
Dr. Axel Korth
Corporate Counsel - Commercial, Biocon Biologics, London, ENGLAND
Dr. Axel Korth is a senior life sciences lawyer with experience both as an in-house legal counsel as well as in private practice. Axel Korth is currently working as Corporate Counsel at Biocon Biologics providing legal and compliance-related advice to Biocon's EU business operations. Prior to joining Biocon Biologics, Axel worked at as Assistant General Counsel at Shionogi and Senior Legal and Regulatory Affairs Advisor at EUCOPE representing the organization at the EC, EMA, HMA, CMDh and other fora with a focus on regulatory and legal affairs. Prior thereto, Axel worked as Head Legal DACH at Biogen with a focus on market access, pricing and reimbursement, general healthcare law and compliance, antitrust and competition, public policy and government affairs. Axel also worked in commercial legal roles as Head Legal MEA and Senior Legal Counsel WEMEA at Sandoz (Novartis group) and held positions of continuing seniority at international law firms Shearman & Sterling LLP and Taylor Wessing.
26/11/2026
26/11/2026
9:00-13:00 CET
online
online
Event - 790€ plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Event - 790€ plus tax
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Jean-Marie Bayhurst
Konferenzmanager Pharma & Healthcare
+49 6221 500-685
j.bayhurst@forum-institut.de
This seminar covers the key regulatory shifts shaping the biosimilars landscape in 2026. Explore how the revised EU pharmaceutical legislation, the EU Biotech Act, and global regulatory convergence impact your biosimilar development and market entry strategy.
This online training provides a compact, practice-oriented update on the regulatory and strategic developments that shape biosimilar projects in 2026.
Using the EU Pharma Reform and the EU Biotech Act as a guiding thread, you will explore what is already clear, where uncertainties remain, and how to translate the evolving framework into robust development and market-entry planning.
By the end of the seminar, you will be able to adapt your current regulatory strategy, identify the most relevant risk drivers for timelines and evidence generation, and derive concrete next steps for your biosimilar portfolio and global planning.
09:00 Introduction and technical warm-up
09:15
Dr. Axel Korth, Dr. Karsten Roth
10:30 Coffee break
10:45
Dr. Axel Korth, Dr. Karsten Roth
11:45 Coffee break
12:00
Dr. Axel Korth, Dr. Karsten Roth
12:45 Final discussion & wrap-up
13:00 End of the seminar
Are you interested in broadening your regulatory horizon? This seminar can be booked as part of the qualification course 'Regulatory Affairs Manager', which provides a structured introduction to regulatory affairs while allowing you to set your own focus areas. It combines guided self-study with interactive online seminars to build a solid understanding of regulatory requirements for human medicinal products. Core principles of EU marketing authorisation form the foundation, with the option to deepen your knowledge through additional online trainings.
Search for the webcode 60012501 on our website for more information and registration or simply click on the link below:
Qualification Course Regulatory Affairs Manager
By booking the qualification course you will save up to 30% compared to individual bookings.
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
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