Current status, anticipated changes and what to prepare for now
Webcode 26112471
Lene Grejs Petersen
Lægemiddelstyrelsen - Danish Medicines Agency, Copenhagen, DENMARK
Quality Assessor
Lene is member of the Clinical Trials Coordinating and Facilitation Group (CTCG) member since 2008 and is the Danish representative of the EU Commission's Advisory Group concerning clinical trials (CTAG) since 2022. Lene has been an employee at the Danish Medicines Agency since 2000 and she has been involved in the implementation of the EU Clinical Trials Regulation into Danish legislation and EU guidance.
More information please click here.
Michael Kahnert
Miltenyi Biotec B.V. & Co. KG, Bergisch Gladbach, GERMANY
Acting Manager Governmental Affairs
Michael holds the position as Acting Manager Governmental Affairs at Miltenyi since October 2022 and has leading experience in different association (e. g. Managing director of European Association of Pharma Biotechnology).
Michael is a lawyer with proven expertise in the life sciences. He advises on all issues relating to the research and development of innovative therapies. He is a certified pharma lawyer with many years of experience in the biotechnology sector.
At the German Biotechnology Association (BIO Deutschland), he led the business fields health policy, diagnostics and regulatory affairs for over 14 years. As managing director and board member of the European Association of Pharma Biotechnology (EAPB), he has been actively involved in technology transfer for several years.
More information please click here.
24/11/2026
24/11/2026
from 9:00 am - 12:30 pm CET
You may dial in 30 minutes before the lecture starts
online
online
Event - 690€ plus tax
The registration fee includes downloadable course materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Event - 690€ plus tax
The registration fee includes downloadable course materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
The EU Biotech Act is still evolving - but preparation cannot wait. Join experts from authority and industry to understand what is coming, what remains uncertain, and how to get your R&D team/organisation ready.
The EU Biotech Act is still taking shape. This half-day seminar gives pharma R&D professionals a concise, expert-led overview of the Act's current scope, legislative timeline, and anticipated implications for clinical trial approval procedures, ATMP development, biosimilar pathways, and regulatory innovation tools.
You leave with the insights needed to brief your teams and to shape your strategies ahead of the Act's adoption.
After having participated in the seminar, you will be equipped with
Welcome, introduction and expectations
Michael Kahnert
Lene Grejs Petersen
Biobreak
Lene Grejs Petersen
Recap and outstanding questions
End of seminar
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You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
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