2025-02-22 2025-02-22 , online online, 1,290 € zzgl. MwSt. Dr. Penelope Gallinger https://forum-institut.de/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

Jetzt buchen

JETZT Buchen

Referenten

Alles auf einen Blick

Termin

23/09/2025

23/09/2025

Zeitraum

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

Veranstaltungsort

online

online

Downloads

Gebühr

Inhouse-Angebote

Your contact

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

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

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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