Repurposed drugs - Access to the European Market
- 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
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
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.
Your speakers
What to Expect
- 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.
Objective of the Event
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, German 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
Programme
9h00 - 17h00
09:00
09:20
Dr. Johanna Huchting
- Drug screening, drug repurposing and data sources
- Biomedical considerations
- FAIR data & from data to knowledge
- Data analysis tools and expert systems
10:20
10:30
Dr. Jan van Dieck, LL.M.
- 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
12:00
Christian Lindenthal, LL.M.
- 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
14:30
Clarissa Junge-Gierse
- Relevance of EU HTA and German AMNOG procedure
- (Limited) role of clinical evidence
- Contracts with health insurance companies? New tender rules due to the newest reform of the GKV system in Germany
15:40
16:00
Dr. Jan van Dieck, LL.M., Clarissa Junge-Gierse, Christian Lindenthal LL.M.
- Panel discussion and Q&A
17:00
Welcome and introduction
09:20
It's all about the data: AI and data-driven approaches to drug repurposing
It's all about the data: AI and data-driven approaches to drug repurposing
Dr. Johanna Huchting
- Drug screening, drug repurposing and data sources
- Biomedical considerations
- FAIR data & from data to knowledge
- Data analysis tools and expert systems
Short break
10:30
Repurposing - IP considerations and opportunities
Repurposing - IP considerations and opportunities
Dr. Jan van Dieck, LL.M.
- 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)
Coffee break
12:00
Regulatory considerations
Regulatory considerations
Christian Lindenthal, LL.M.
- 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
Lunch break
14:30
Market Access strategies
Market Access strategies
Clarissa Junge-Gierse
- Relevance of EU HTA and German AMNOG procedure
- (Limited) role of clinical evidence
- Contracts with health insurance companies? New tender rules due to the newest reform of the GKV system in Germany
Coffee break
16:00
Strategic decisions at the edge of IP - Regulatory Affairs - HTA
Strategic decisions at the edge of IP - Regulatory Affairs - HTA
Dr. Jan van Dieck, LL.M., Clarissa Junge-Gierse, Christian Lindenthal LL.M.
- Panel discussion and Q&A
Seminar end
Downloads
Request the documents using our form.
Brochure
Market Access Basic Concepts
Weitere Informationen
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.
Our Recommendations
Further Information
Your Contact Person
We are happy to advise you personally and individually.
Dr. Henriette Wolf-Klein
Department Manager
+49 6221 500-680
h.wolf-klein@forum-institut.de