2024-06-12 2024-06-12 , online online, 1,290 € plus tax Dr Paul de Boissieu https://www.forum-institut.com/seminar/24092001-joint-clinical-assessments-count-down-eu-hta/referenten/24/24_09/24092001-joint-clinical-assessments-count-down-eu-hta_de-boissieu-paul.jpg Joint Clinical Assessments - Count down EU-HTA

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

Topics
  • Assessment scope: assessment scope proposal and scoping process
  • Starting point - information submission to HTA Secretariat and EMA
  • JCA dossier preparation
  • 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, starting in January 2025. 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 upcoming 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 January 2025

24092001 Seminar Joint Clinical Assessments - Count down EU-HTA

Joint Clinical Assessments - Count down EU-HTA

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 24092001

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

24/09/2024

24/09/2024

Period

9:00 am - 5:00 pm

9:00 am - 5:00 pm
Venue

online

online

Fee
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: assessment scope proposal and scoping process
  • Starting point - information submission to HTA Secretariat and EMA
  • JCA dossier preparation
  • 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, starting in January 2025. 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 upcoming 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 January 2025

Detailed programme

9:00 am - 5:00 pm

09:00 Introduction


09:15

Dr Paul de Boissieu

Start of EU-HTA in 3 months' time: Concept of the 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

Dr Paul Bolot

Starting point: Submission to EMA and HTA Secretariat - a regulatory perspective
  • Sponsor consideration on SmPC and clinical overview with EU HTA in mind
  • Considerations for JSC / learning from EMA pilot

11:50 Short break


12:00

Dr Thomas Ecker

JCA dossier preparation step by step
  • 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

17:00 End of the seminar


Further information

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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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