2022-01-21 2022-01-21 , Online Online, 1.090,- € zzgl. MwSt. Dr. Dan Dammann https://www.forum-institut.de/seminar/22012003-market-access-of-orphan-drugs/referenten/22/22_01/22012003-course-market-access-of-orphan-drugs_dammann-dan.jpg Market Access of Orphan Drugs

Evidence generation, value proposition and the HTA - the latest insights with regard to Orphan Drugs

Topics
  • Evidence generation with small patient groups
  • Evaluation of the orphan and paediatric legislation
  • Orphan drugs in the German AMNOG procedure
  • Value proposition from a health insurance perspective
  • Value creation process for a launch in the EU4 and the UK
Aims and objectives
The orphan drug sector is about to change. EU orphan drug and paediatric legislation is under review and the EU HTA is fast approaching - it is time for a thorough update on regulatory and HTA issues.

This course provides the latest on marketing authorisation and market access, as well as practical tips for evidence generation and value creation.
Who should attend

This course addresses the needs of all who are involved in regulatory affairs or market access with small patient groups or orphan drug status. It is also recommended for those who address medical affairs and clinical issues related to orphan drugs.

Course: Market Access of Orphan Drugs

Market Access of Orphan Drugs

Focus the EU4 and the UK

Benefits
  • Experts provide HTA, regulatory body, health insurance and industry perspectives in a single course
  • Learn how regulatory affairs and the HTA fit together
  • We are following the IMI quality criteria

Webcode 22012003

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

21.01.2022

21.01.2022

Zeitraum

from 09:00 - 17:00 You may dial in 3...

from 09:00 - 17:00 You may dial in 30 min. before the session
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Dr. Henriette Wolf-Klein
Head of Department

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

Details

Evidence generation, value proposition and the HTA - the latest insights with regard to Orphan Drugs

Topics
  • Evidence generation with small patient groups
  • Evaluation of the orphan and paediatric legislation
  • Orphan drugs in the German AMNOG procedure
  • Value proposition from a health insurance perspective
  • Value creation process for a launch in the EU4 and the UK
Aims and objectives

The orphan drug sector is about to change. EU orphan drug and paediatric legislation is under review and the EU HTA is fast approaching - it is time for a thorough update on regulatory and HTA issues.

This course provides the latest on marketing authorisation and market access, as well as practical tips for evidence generation and value creation.

Who should attend

This course addresses the needs of all who are involved in regulatory affairs or market access with small patient groups or orphan drug status. It is also recommended for those who address medical affairs and clinical issues related to orphan drugs.

Detailed programme

from 09:00 - 17:00 You may dial in 30 min. before the session

Introduction


Sophie Schmitz

The appropriate route to market for your product group - strategic thinking

Short break


Sophie Schmitz

Evidence generation with small patient groups

Dr Frauke Naumann-Winter

Marketing authorisation of orphan drugs in the EU
  • Evaluation of the orphan drug status after initial designation (before and after EC Notice 2016/C 242/03)
  • Relevance of register data in marketing authorisation and conditions after approval
  • EC joint evaluation of orphan and paediatric legislation

Lunch break


Dr Yvonne Schmidt

Orphan drugs in the German AMNOG procedure
  • Requirements for the dossier
  • Additional benefit and re-evaluationof the additional benefit
  • Re-evaluation of the evidence
  • Register requirements and conditions ('anwendungsbegleitende Datenerhebung')
  • Orphan drugs and the EU HTA:New possibilities?

Coffee break


Dr Dan Dammann

Value proposition of orphan drugs from a health insurance perspective

Short break


Pietro Sternini

Value creation process in the run-up to a launch in the EU4 and the UK: a manufacturer's perspective

Seminar end


More information

Why you should attend

  • Experts provide HTA, regulatory body, health insurance and industry perspectives in a single course
  • Learn how regulatory affairs and the HTA fit together

FAQs/What are the system requirements?

You need a reliable Internet connection and a browser. The following Windows browsers are applicable:

  • Internet Explorer 8 onwards
  • Mozilla Firefox
  • Google Chrome

_______________

We recommend you use the Zoom app to connect with your mobile device.
You will need a headset, loudspeakers or a telephone for audio.

_______________

Can I test my equipment beforehand?
Yes, you can check whether everything will work properly on the day of your online training.
Just click the following link to run a test: https://zoom.us/test

_______________

Do I have to use a headset for the online seminar?
No. In addition to all popular microphones and loudspeakers, Zoom also supports dial-in access by telephone. However, working with a headset is much more convenient for online seminars.

How does an online seminar work?

The Zoom webcasts are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live, using the chat function.

1. You will receive brief instructions on how to use Zoom online seminars beforehand.
2. Use a headset, loudspeakers or the telephone for audio.
3. Listen to the speaker and follow the presentation.
4. Use the chat function to ask questions.

The benefits of an online seminar

  • Attend the webcasts in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live, using the chat function

This distinguishes our events

Overall score of all evaluations in 2020

Five stars on Trustpilot = Excellent

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Technical requirements

Here you can find the technical requirements for our online events that must be met.

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Technical requirements
List of abbreviations

Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

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Abbreviations, Glossary
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