2024-11-12 2024-11-12 , online online, 1,290 € zzgl. MwSt. Dr Paul de Boissieu https://forum-institut.de/seminar/25032001-jca-dossiers-joint-clinical-assessments/referenten/25/25_03/25032001-jca-dossiers-joint-clinical-assessments_de-boissieu-paul.jpg JCA Dossiers & Joint Clinical Assessments

Here you will get the latest information on the process of joint clinical assessments, including scoping and JCA dossier preparation.

Topics
  • Assessment scope: scope proposal and scoping process
  • Starting point: Submission to HTA Secretariat and EMA
  • JCA dossier preparation
  • Joint clinical assessment according to the implementing act
  • JCA dossiers: commonalities and differences to national HTA dossiers in Germany, France, Italy, Spain and the UK


Who should attend
This seminar is aimed at specialists and managers in the pharmaceutical industry who bring new medicinal products to market. In particular, staff from the clinical development, outcomes research and market access departments will gain valuable information on study planning and future market access preparations.
Aims and objectives
This seminar helps you to prepare for EU HTA. It has a strong focus on the process of Joint Clinical Assessments, addressing the scoping process as well as the JCA dossier preparation.

After attending the seminar, you will be familiar with the new JCA process and know the commonalities and differences to national HTA dossiers in Germany, France, Italy, Spain, and the UK.
Your benefit

  • Firsthand information from the Joint Clinical Assessments subgroup.
  • National know-how from Germany, France, Spain, Italy, and the UK.
  • Knowledge on how to prepare for your first EU HTA procedure.

25032001 Seminar JCA Dossiers & Joint Clinical Assessments

JCA Dossiers & Joint Clinical Assessments

Benefits
  • Firsthand information from the Joint Clinical Assessments subgroup
  • National know-how from Germany, France, Spain, Italy, and the UK
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25032001

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

24/03/2025

24/03/2025

Zeitraum

9:00 am - 5:00 pm

9:00 am - 5:00 pm
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Henriette Wolf-Klein
Head of Department

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

Details

Here you will get the latest information on the process of joint clinical assessments, including scoping and JCA dossier preparation.

Topics

  • Assessment scope: scope proposal and scoping process
  • Starting point: Submission to HTA Secretariat and EMA
  • JCA dossier preparation
  • Joint clinical assessment according to the implementing act
  • JCA dossiers: commonalities and differences to national HTA dossiers in Germany, France, Italy, Spain and the UK


Who should attend
This seminar is aimed at specialists and managers in the pharmaceutical industry who bring new medicinal products to market. In particular, staff from the clinical development, outcomes research and market access departments will gain valuable information on study planning and future market access preparations.

Aims and objectives

This seminar helps you to prepare for EU HTA. It has a strong focus on the process of Joint Clinical Assessments, addressing the scoping process as well as the JCA dossier preparation.

After attending the seminar, you will be familiar with the new JCA process and know the commonalities and differences to national HTA dossiers in Germany, France, Italy, Spain, and the UK.

Your benefit

  • Firsthand information from the Joint Clinical Assessments subgroup.
  • National know-how from Germany, France, Spain, Italy, and the UK.
  • Knowledge on how to prepare for your first EU HTA procedure.

Detailed programme

9:00 am - 5:00 pm

09:00 Introduction


09:15

Dr Paul de Boissieu

Start of EU-HTA: Joint clinical assessment according to the implementing act
  • JCA stakeholders
  • Assessment scope: assessment scope proposal and scoping process
  • Draft joint assessment & summary report

10:45 Coffee break


11:00

Birgit Wolf

Starting point: Submission to EMA and HTA Secretariat - a regulatory perspective
  • Considerations for JSC / learning from parallel EMA/HTAb scientific advice
  • Regulatory consideration on JCA and parallel EMA review process ,including information exchange

11:50 Short break


12:00

Dr Thomas Ecker

JCA dossier preparation step by step - first-hand experiences
  • Identification of anticipated PICOs
  • What can be prepared in advance?
  • Statistics and quality control
  • Interaction with affiliates and authorities
  • Project management, flexibility and agility

12:45 Lunch break


13:45

Christian Hill, Alain Estival, Mariangela Prada, Luis Lizán

JCA dossier preparation - commonalities and differences to national HTA dossiers
  • JCA dossier - UK perspective
  • JCA dossier - French perspective
  • JCA dossier - Italian perspective
  • JCA dossier - Spanish perspective

15:45 Coffee break


16:00

Dr. Marco Penske

Current challenges and opportunities
  • Collaboration of global and local access teams
  • Interaction of joint assessment and local GBA decision
  • Success factors
  • Outlook: What's coming next?

17:00 End of the seminar


Further information

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.

Free pre-meeting and technology check

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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