2025-02-22 2025-02-22 , online online, 1,290 € plus tax Dr. Penelope Gallinger https://forum-institut.com/seminar/25092000-amnog-and-the-eu-hta-insights-into-the-german-market/referenten/25/25_09/25092000-amnog-and-the-eu-hta-insights-into-the-german-market_gallinger-penelope.jpg AMNOG and the EU HTA - Insights into the German Market

This seminar will focus on AMNOG and JCA dossier preparation as well as the German AMNOG procedure in comparison with the EU HTA procedure.

Topics
  • The AMNOG dossier: storyline and demonstration of evidence
  • The EU JCA dossier in comparison with the AMNOG dossier
  • Early benefit assessment at the G-BA and subsequent price negotiation
  • The EU HTA process in detail


Who should attend
This seminar addresses the needs of employees in the pharmaceutical industry who require profound insight into AMNOG, the German HTA procedure, and knowledge of the upcoming EU HTA procedure. It is intended for market access beginners as well as marketing and medical affairs specialists who need extensive know-how in this field.
Aims and objectives
Are you involved in the market access of innovative drugs in Germany? Do you need to understand the main principles involved, especially in comparison with the EU HTA procedure?

Then this seminar will familiarise you with the main tasks and hurdles along the way. Three outstanding market access experts will guide you through the procedure and can answer your questions on both the national and the EU level.
Your benefit

  • Knowledge of the German market concerning the market access of innovative drugs.
  • The ability to support market access in Germany in terms of dossier preparation and process know-how.
  • The ability to deal with the upcoming changes as a result of the EU HTA.

25092000 Seminar AMNOG and the EU HTA - Insights into the German Market

AMNOG and the EU HTA - Insights into the German Market

Benefits
  • JCA dossier and AMNOG dossier
  • AMNOG and EU HTA procedure in comparison
  • Officially certified to the ISO 9001 and ISO 21001 standards

Webcode 25092000

Book now

JETZT Buchen
Speakers

Dr. Penelope Gallinger

IQVIA Commercial GmbH & Co. OHG, München, Germany

Principal Market Access und HTA RWAS Real-World & Analytics Solutions
More information please click here.

Marcus Reich

Roche Pharma AG, Grenzach-Wyhlen

Strategic Pricing & Reimbursement Innovation Lead

Dr. Vanessa Elisabeth Schaub

F. Hoffmann-La Roche Ltd, Basel, Switzerland

Head Global & EU HTA Strategy

Everything at a glance

Appointment

23/09/2025

23/09/2025

Period

9:00 am - 5:00 pm seminar
You may dial in 30 minutes in advance

9:00 am - 5:00 pm seminar
You may dial in 30 minutes in advance
Venue

online

online

Downloads
Fee

Event - 1,290 € plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Event - 1,290 € plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Inhouse-offers
Request inhouse-offer
Request inhouse-offer

Book now

Your contact

Dr. Henriette Wolf-Klein
Head of Department

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

Details

This seminar will focus on AMNOG and JCA dossier preparation as well as the German AMNOG procedure in comparison with the EU HTA procedure.

Topics

  • The AMNOG dossier: storyline and demonstration of evidence
  • The EU JCA dossier in comparison with the AMNOG dossier
  • Early benefit assessment at the G-BA and subsequent price negotiation
  • The EU HTA process in detail


Who should attend
This seminar addresses the needs of employees in the pharmaceutical industry who require profound insight into AMNOG, the German HTA procedure, and knowledge of the upcoming EU HTA procedure. It is intended for market access beginners as well as marketing and medical affairs specialists who need extensive know-how in this field.

Aims and objectives

Are you involved in the market access of innovative drugs in Germany? Do you need to understand the main principles involved, especially in comparison with the EU HTA procedure?

Then this seminar will familiarise you with the main tasks and hurdles along the way. Three outstanding market access experts will guide you through the procedure and can answer your questions on both the national and the EU level.

Your benefit

  • Knowledge of the German market concerning the market access of innovative drugs.
  • The ability to support market access in Germany in terms of dossier preparation and process know-how.
  • The ability to deal with the upcoming changes as a result of the EU HTA.

Detailed programme

9:00 am - 5:00 pm seminar
You may dial in 30 minutes in advance

09:00 Welcome and introduction


09:15

Dr Penelope Gallinger

The AMNOG Dossier - the key essentials
  • Strategic planning, the key essentials
  • Dossier structure and templates
  • Module 3 - storyline and therapeutic value and benefits
  • Module 4 - demonstration of evidence
  • The crucial points: the appropriate comparative therapy and the biostatistical analysis of the study groups

10:15 Short break


10:25

Dr Penelope Gallinger

Continuation: The AMNOG Dossier - the key essentials

11:30 Coffee break


11:45

Dr Penelope Gallinger, Dr Vanessa Elisabeth Schaub

The EU HTA dossier (JCA dossier) in comparison with the AMNOG dossier
  • The JCA dossier structure at a glance
  • Commonalities and differences in comparison with the AMNOG dossier
  • How to handle various PICO schemes in Europe - pre-specification options
  • Real-life insights from a company that prepares dossiers

13:00 Lunch break


14:00

Dr. Penelope Gallinger, Marcus Reich

The AMNOG procedure
  • Early benefit assessment at the G-BA - first contact, scientific advice, comment procedure and hearing
  • Price negotiation at the GKV-Spitzen-verband - what can be negotiated, payment terms and the challenge for drugs in combination with others

15:45 Coffee break


16:00

Dr Vanessa Elisabeth Schaub

The EU HTA procedure in comparison - what changes now?
  • Start of the HTA process in parallel with the marketing authorisation procedure
  • The EU HTA process in detail
  • Challenge: changes in the marketing authorisation approval process

17:00 End of seminar


Further information

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