EU Biotech Act: What Pharma R&D Professionals need to know
Current status, anticipated changes and what to prepare for now
- Expert-led insights: Authority and industry perspective
- Regulatory clarity according to the status quo
- Knowledge for timely strategic preparation
- Officially certified: ISO 9001 + 21001
Online-Seminar
From
690,00 €
plus VAT
Services & Process
Veranstaltung - 690,-€ zzgl. MwSt.
The registration fee includes downloadable course materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Period:
from 9:00 am - 12:30 pm CET
You may dial in 30 minutes before the lecture starts
Booking details
Online-Seminar
From
690,00 €
plus VAT
Services & Process
Veranstaltung - 690,-€ zzgl. MwSt.
The registration fee includes downloadable course materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Period:
from 9:00 am - 12:30 pm CET
You may dial in 30 minutes before the lecture starts
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.
Your speakers
Lene Grejs Petersen
Lægemiddelstyrelsen - Danish Medicines Agency,
Copenhagen, DENMARK
Quality Assessor
Lene is member of the Clinical Trials Coordinating and Facilitation Group (CTCG) since 2008 and is the Danish…
Your speaker
Lene Grejs Petersen
Lægemiddelstyrelsen - Danish Medicines Agency,
Copenhagen, DENMARK
Quality Assessor
Lene is member of the Clinical Trials Coordinating and Facilitation Group (CTCG) 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.
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…
Your speaker
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.
What to Expect
- Biotech Act: Overview and legislative context
- Accelerating clinical trials: What changes?
- Regulatory innovation support
- Implications for Pharma R&D: A regulatory perspective
Who Should Attend
The seminar addresses professionals in pharma R&D organisations who need to understand and prepare for the EU Biotech Act.
It is particularly relevant for those working in biopharmaceutical research and development, including preclinical and clinical settings. A background in drug development, clinical trials, or regulatory affairs is recommended.
Objective of the Event
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.
Your Benefit
After having participated in the seminar, you will be equipped with
A clear picture of the legislative status
(according to the current status of the legislative process)
- Practical insights into clinical trial changes
Expert perspectives from authority and industry
- Actionable strategies for your R&D organisation
Programme
from 9:00 am - 12:30 pm CET
Michael Kahnert
- Background: Why the EU needs a Biotech Act
- The EU Commission's objective and how it differs from existing regulations (ATMP, MDR, EMA regulations)
- Structure and scope of the EU Biotech Act
- Status of the legislative process and timeline
Lene Grejs Petersen
- Simplifying permitting procedures - What are the legislators planning?
- Approval procedures under the Biotech Act vs. EU-CTR
- Revised timelines and simplified approval procedures under the amended CTR
- New categories: Minimal-intervention trials and combined studies
- Changes to GMO assessment and new core dossier
- Data protection harmonisation in clinical trials (General Data Protection Regulation [GDPR])
- Interfaces with GCP, GMP, and pharmacovigilance
Michael Kahnert
- Regulatory sandboxes and the EU Health Biotechnology Support Network
- SPC (Supplementary Protection Certificate) extension: Eligibility criteria and practical relevance
- Biosimilar development: Tailored regulatory pathways
- AI and digital tools in drug development
Lene Grejs Petersen
- Authority expectations: What sponsors and researchers need to prepare for
- Opportunities and risks from a European regulatory viewpoint
- Interaction with existing frameworks (MDR, IVDR, EHDS)
Welcome, introduction and expectations
The EU Biotech Act: Overview and legislative context
The EU Biotech Act: Overview and legislative context
Michael Kahnert
- Background: Why the EU needs a Biotech Act
- The EU Commission's objective and how it differs from existing regulations (ATMP, MDR, EMA regulations)
- Structure and scope of the EU Biotech Act
- Status of the legislative process and timeline
Accelerating clinical trials: What changes? (Content reflects the current status of the legislative process.)
Accelerating clinical trials: What changes? (Content reflects the current status of the legislative process.)
Lene Grejs Petersen
- Simplifying permitting procedures - What are the legislators planning?
- Approval procedures under the Biotech Act vs. EU-CTR
- Revised timelines and simplified approval procedures under the amended CTR
- New categories: Minimal-intervention trials and combined studies
- Changes to GMO assessment and new core dossier
- Data protection harmonisation in clinical trials (General Data Protection Regulation [GDPR])
- Interfaces with GCP, GMP, and pharmacovigilance
Regulatory innovation support
Regulatory innovation support
Michael Kahnert
- Regulatory sandboxes and the EU Health Biotechnology Support Network
- SPC (Supplementary Protection Certificate) extension: Eligibility criteria and practical relevance
- Biosimilar development: Tailored regulatory pathways
- AI and digital tools in drug development
Biobreak
Implications for Pharma R&D: A regulatory perspective
Implications for Pharma R&D: A regulatory perspective
Lene Grejs Petersen
- Authority expectations: What sponsors and researchers need to prepare for
- Opportunities and risks from a European regulatory viewpoint
- Interaction with existing frameworks (MDR, IVDR, EHDS)
Recap and outstanding questions
End of seminar
Downloads
Request the documents using our form.
Brochure
Abbreviation list_Clinical Research
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Further Information
Your Contact Person
We are happy to advise you personally and individually.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de