2022-02-23 2022-02-23 , Online Online, 1.090,- € zzgl. MwSt. Dr. Marc Christian Bauer https://www.forum-institut.de/seminar/2202232-expanded-access-programmes/referenten/22/22_02/2202232-course-expanded-access-programmes_bauer-marc-christian.jpg Expanded Access Programmes

Compassionate Use Programme (CUP) and Named Patient Programme (NPP) - the expertise required to plan and conduct expanded access programmes.

Topics
  • Matching the programme and the company strategy
  • Programme design: CUP and NPP
  • Medical governance and programme integrity
  • From early access to regular launch: transitional plan, pricing, supply chain
Aims and objectives
Are you about to decide whether an expanded access programme should be developed or are you already about to plan and execute one? Then, this seminar supports you with legal and medical know-how. After having attended the seminar you know what to bear in mind in the planning phase, have received practical tipps on how to do the medical oversight and how to determine a potential programme end.
Who should attend

This seminar will provide in-depth information on CUPs and NPPs to all involved in clinical affairs, medical affairs, health technology assessment (HTA) and healthcare management, particularly those who develop, plan and conduct expanded access programmes.

Course: Expanded Access Programmes

Expanded Access Programmes

Benefits
  • Three experts with extensive experience in setting up and conducting expanded access programmes
  • A direct comparison between CUPs and NPPs
  • We are following the IMI quality criteria

Webcode 2202232

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

23.02.2022

23.02.2022

Zeitraum

from 09:00 - 17:00You may dial in 30...

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

Compassionate Use Programme (CUP) and Named Patient Programme (NPP) - the expertise required to plan and conduct expanded access programmes.

Topics
  • Matching the programme and the company strategy
  • Programme design: CUP and NPP
  • Medical governance and programme integrity
  • From early access to regular launch: transitional plan, pricing, supply chain
Aims and objectives

Are you about to decide whether an expanded access programme should be developed or are you already about to plan and execute one? Then, this seminar supports you with legal and medical know-how. After having attended the seminar you know what to bear in mind in the planning phase, have received practical tipps on how to do the medical oversight and how to determine a potential programme end.

Who should attend

This seminar will provide in-depth information on CUPs and NPPs to all involved in clinical affairs, medical affairs, health technology assessment (HTA) and healthcare management, particularly those who develop, plan and conduct expanded access programmes.

Detailed programme

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

09:00 Introduction, participants' expectations


09:15

Dr Marc Christian Bauer

Introduction and decision tree - matching the programme and the company strategy
  • Why set up a programme?Pros and cons
  • Legal framework and preconditions: unmet medical need
  • Named Patient Programme (NPP)
  • Compassionate Use Programme (CUP)
  • All the EU, CH, UK or specific countries?
  • Should supply be free of charge or against payment?
  • Exercise: Pros and cons of a programme

10:30 Coffee break and time for discussion


10:50

Dr Stuart Bell

Early access programme design
  • Intentions behind the programme
  • Regulatory pathway selection
  • Time frame and duration
  • Infrastructure and logistics:Should a partner be involved?
  • Costs and results
  • Project planning
  • Starting point and timing
  • Outcomes research in EAPs:HTA in the focus, too?
  • Exercise: An early access approach from the perspective of a small EU biotech company

12:10 Lunch break


13:10

Sarah Moore

Medical oversight and implementing early access programmes
  • Medical governance andprogramme integrity
  • The challenges of execution
  • Strategies and tools to maximise success
  • Partnering with an access vendor
  • Pharmacovigilance obligationsand best practice

14:30 Coffee break and time for discussion


15:00

Dr Marc Christian Bauer

Should the programme end? From early access to regular launch
  • Unlimited programmes versus programmes that end with the marketing authorisation - consequences
  • From early access to regular launch: transitional plan, pricing, supply chain

16:15 Final discussion


17:00 End of seminar


More information

Your benefits

  • Three experts with extensive experience in setting up and conducting expanded access programmes
  • A direct comparison between CUPs and NPPs
  • Strategic information on country selection, outcome research possibilities and much more

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

Recommendations

Generic Market Access & Pricing in Europe

Online Seminar about Generic Market Access & Pricing in Europe

22.02.2022, Online
Details

The Person Responsible for Regulatory Compliance

How to prepare effectively for the responsibilities of a person responsible for regulatory compliance (PRRC). This and m...

22.03.2022, Online
Details

Supplier Management for Medical Devices

An up-to-date overview of and insights into supplier management for medical devices and related activities: Find the rig...

26.10.2021, Online
Details
Marketing Authorisation of Medical Devices in Saudi Arabia, the UAE and Jordan

Medical Devices: Marketing authorisation and market access in Saudi Arabia, the UAEand Jordan. Don't miss out on this un...

18.11.2021, Online
Details

Writing for Medical Devices

The online course will show you how to write scientific and clinical documents such as a technical documentation or clin...

25. - 26.11.2021, Online
Details

Go forward

Technical requirements

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

Details
Technical requirements
List of abbreviations

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

Details
Abbreviations, Glossary
Quality guaranteed!

Your feedback produced as result of 1.7 in 2020. Thank you!

Details
More on our quality criteria