2026-06-17 2026-06-17 , online online, 1,290 € zzgl. MwSt. Dr. Johanna Huchting https://www.forum-institut.de/seminar/26112003-repurposed-drugs-access-to-the-european-market/referenten/26/26_11/26112003-repurposed-drugs-access-to-the-european-market_huchting-johanna.jpg Repurposed drugs - Access to the European Market

This online seminar equips regulatory affairs, IP, legal and market access professionals with practical strategies to navigate the complex journey from drug repurposing to European market authorisation and market access.

Topics
  • AI and data-driven approaches to drug repurposing
  • IP considerations and opportunities
  • Regulatory considerations: Data exclusivity, regulatory pathways
  • Market Access strategies
  • Strategic decisions at the edge of IP - Regulatory Affairs - HTA


Who should attend
This online seminar is designed for regulatory affairs, IP, legal and market access professionals seeking to bring repurposed drugs to market. A basic understanding of regulatory and IP requirements as well as general market access principles is recommended.
Aims and objectives
This seminar provides comprehensive insights into the regulatory, IP and market access challenges of bringing repurposed drugs to the European market.

Participants will gain practical insights into:
  • Data-driven approaches to drug repurposing using AI technologies
IP strategies for protecting repurposed drugs
  • Regulatory pathways for repurposed drugs
  • Market access considerations, particularly EU HTA, AMNOG procedures and recent legal novelties

After having attended the seminar you will be able to align IP protection, regulatory pathways and HTA requirements into cohesive strategic decisions.
Your benefit

After having attended the seminar you will have practical hints on how to

  • identify repurposing opportunities
  • protect your innovations with tailored IP strategies for generic and patented drugs in new indications
  • choose the most efficient regulatory pathway for your repurposed drug
  • secure market access by anticipating HTA requirements and reimbursement hurdles

26112003 Seminar Repurposed drugs - Access to the European Market

Repurposed drugs - Access to the European Market

Benefits
  • Identify repurposing opportunities and protect them
  • Choose efficient regulatory pathways
  • Secure market access and reimbursement
  • Officially certified to the ISO 9001 and ISO 21001 standards

Webcode 26112003

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

12/11/2026

12/11/2026

Zeitraum

9h00 - 17h00

9h00 - 17h00
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Henriette Wolf-Klein
Department Manager

+49 6221 500-680
h.wolf-klein@forum-institut.de

Details

This online seminar equips regulatory affairs, IP, legal and market access professionals with practical strategies to navigate the complex journey from drug repurposing to European market authorisation and market access.

Topics

  • AI and data-driven approaches to drug repurposing
  • IP considerations and opportunities
  • Regulatory considerations: Data exclusivity, regulatory pathways
  • Market Access strategies
  • Strategic decisions at the edge of IP - Regulatory Affairs - HTA


Who should attend
This online seminar is designed for regulatory affairs, IP, legal and market access professionals seeking to bring repurposed drugs to market. A basic understanding of regulatory and IP requirements as well as general market access principles is recommended.

Aims and objectives

This seminar provides comprehensive insights into the regulatory, IP and market access challenges of bringing repurposed drugs to the European market.

Participants will gain practical insights into:

  • Data-driven approaches to drug repurposing using AI technologies
IP strategies for protecting repurposed drugs
  • Regulatory pathways for repurposed drugs
  • Market access considerations, particularly EU HTA, AMNOG procedures and recent legal novelties

After having attended the seminar you will be able to align IP protection, regulatory pathways and HTA requirements into cohesive strategic decisions.

Your benefit

After having attended the seminar you will have practical hints on how to

  • identify repurposing opportunities
  • protect your innovations with tailored IP strategies for generic and patented drugs in new indications
  • choose the most efficient regulatory pathway for your repurposed drug
  • secure market access by anticipating HTA requirements and reimbursement hurdles

Detailed programme

9h00 - 17h00

09:00 Welcome and introduction


09:20

Dr. Johanna Huchting

It's all about the data: AI and data-driven approaches to drug repurposing
  • Drug screening, drug repurposing and data sources
  • Biomedical considerations
  • FAIR data & from data to knowledge
  • Data analysis tools and expert systems

10:20 Short break


10:30

Dr. Jan van Dieck, LL.M.

Repurposing - IP considerations and opportunities
  • What is repurposing?
  • Intellectual property frictions to be solved and new protections to be obtained
  • Generic drugs versus patented drugs in new indications
  • Second medical use - claim options
  • IP strategy: FTO
  • Skinny Label?
  • Relevance of supplementary protection certificates in the context of repurposing strategies (prodrugs, drug combinations, new formulations)

11:40 Coffee break


12:00

Christian Lindenthal, LL.M.

Regulatory considerations
  • Data/Market exclusivity
  • Scope of indication and labelling
  • Necessary data and bridging possibilities
  • Regulatory pathways
  • New challenges and opportunities in conjunction with the EU pharmaceutical package

13:10 Lunch break


14:30

Clarissa Junge-Gierse

Market Access strategies
  • Relevance of EU HTA and AMNOG procedure
  • (Limited) role of clinical evidence
  • Contracts with health insurance companies? New tender rules due to the newest reform of the GKV system

15:40 Coffee break


16:00

Dr. Jan van Dieck, LL.M.

Strategic decisions at the edge of IP - Regulatory Affairs - HTA
  • Panel discussion and Q&A

17:00 Seminar end


Ihr Nutzen

Technical requirements

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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We are now officially certified to ISO 9001 and ISO 21001 standard.

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