Market Access Starts in Regulatory Affairs
Aligning Clinical Development, Marketing Authorisation and EU HTA for Innovative Medicines
- Identify the key interfaces and follow the process through EU HTA
- Learn how to support a successful EU HTA outcome
- Officially certified to the ISO 9001 and ISO 21001 standards
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Designed for Regulatory Affairs, Market Access and Outcomes Research professionals, this seminar shows why Market Access starts in Regulatory Affairs and how the key interfaces shape the path to a successful EU HTA outcome.
Your speakers
Carolin Knorr
DLRC Regulatory Consultancy
Market Access/HTA Principal Consultant
Your speaker
Carolin Knorr
DLRC Regulatory Consultancy
Market Access/HTA Principal Consultant
Ahmed Seddik
Boehringer Ingelheim International GmbH, GERMANY
Corporate Director HEOR, Obesity & Liver Health, Pipeline
Your speaker
Ahmed Seddik
Boehringer Ingelheim International GmbH, GERMANY
Corporate Director HEOR, Obesity & Liver Health, Pipeline
Victoria Unmüßig
Astellas Pharma GmbH, München, GERMANY
EU HTA Lead;
Global Access & Value and Public Policy
Your speaker
Victoria Unmüßig
Astellas Pharma GmbH, München, GERMANY
EU HTA Lead;
Global Access & Value and Public Policy
Matteo Scarabelli
EFPIA
Associate Director Market Access
Your speaker
Matteo Scarabelli
EFPIA
Associate Director Market Access
What to Expect
- Clinical development programme & Outcomes Research under Regulatory Affairs and HTA Premises
- Regulatory Advice, Joint (parallel) Advice, Scientific Advice, National Advice - how to match regulatory and HTA topics?
- Learnings from the First JCAs and Implications for Future Clinical Development and Data Generation
- Particularities of ATMPs and Orphan Drugs in further indications
Who Should Attend
This seminar is intended for Regulatory Affairs and Market Access professionals, as well as professionals working in Outcomes Research. Basic knowledge of Regulatory Affairs and Market Access is recommended and can be obtained in our e-learnings.
Objective of the Event
This seminar demonstrates why successful Market Access starts well before market launch, with the regulatory strategy and clinical development programme.
You will gain a clear understanding of the key interfaces between Regulatory Affairs, Clinical Development and Market Access and will follow the process from early development and Scientific Advice through Marketing Authorisation and preparation for the EU HTA process.
You will learn how regulatory and HTA requirements can be aligned at an early stage, how evidence generation and clinical development decisions influence the subsequent Joint Clinical Assessment, and how cross-functional collaboration can support a coherent evidence strategy and a successful outcome in the EU HTA process.
Your Benefit
- Identify the key interfaces between regulatory and HTA requirements.
- Align clinical development, Scientific Advice and evidence generation.
- Prepare for the EU HTA process alongside the marketing authorisation process.
- Develop a coherent cross-functional strategy from early development to EU HTA.
Downloads
Request the documents using our form.
Market Access Basic Concepts
Further Informations
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.
Access to and procedure for online events
Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.
All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.
On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.
Learn more about our online events here.
Free pre-meeting and technology check
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
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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Further Information
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In-house seminars
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Your Contact Person
We are happy to advise you personally and individually.
Dr. Henriette Wolf-Klein
Department Manager
+49 6221 500-680
h.wolf-klein@forum-institut.de