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
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Buchungsdetails
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
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
TA Obesity, Liver Health;
Dr. Ahmed Seddik currently serves as Interim Global Market Access and HEOR Lead for a Phase 2/3 asset in the Obesity & Liver…
Your speaker
Ahmed Seddik
Boehringer Ingelheim International GmbH, GERMANY
TA Obesity, Liver Health;
Dr. Ahmed Seddik currently serves as Interim Global Market Access and HEOR Lead for a Phase 2/3 asset in the Obesity & Liver therapeutic area. He has more than 10 years of experience in HEOR, value and access, pricing, and evidence generation across pharmaceutical industry and consulting roles. He holds a PhD in Health Economics from the University of Groningen and has authored numerous publications on health economic evaluation, market access, and the societal impact of medical innovation.
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
Servier
EU HTA Strategy Director;
Matteo Scarabelli started building his expertise in the pharmaceutical market within Eurordis (rare disease patient group) as responsible for the involvement of…
Your speaker
Matteo Scarabelli
Servier
EU HTA Strategy Director;
Matteo Scarabelli started building his expertise in the pharmaceutical market within Eurordis (rare disease patient group) as responsible for the involvement of patients in Ad Boards, EMA advice and evaluation, and in HTA and reimbursement decisions for orphan drugs.
Matteo then joined EFPIA where he staffed the working groups on HTA and Orphan drugs, securing the liaison with the Regulatory groups and coordinating with the respective HTA functions in the national affiliates.
For the last four years at EFPIA, he supported the companies preparing for the new EU HTA dossier (for the joint clinical assessment, JCA) and the consequent changes in national pricing and reimbursement.
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.
Programme
09h:00 - 17h:00
09:00
09:20
Ahmed Seddik
10:20
10:40
Carolin Knorr
- Part 1: Integration of Regulatory and HTA Advice
- Regulatory advice, (parallel) Joint Scientific Consultation, and national HTA advice - how can requests, key questions, timelines, and objectives be aligned most effectively?
11:40
11:50
Carolin Knorr
- Part 2: From Advice to Regulatory and HTA Submission
- How can the interface between Regulatory and HTA be effectively managed from the late development phase through the MAA and onwards to the JCA?
12:50
14:00
Victoria Unmüßig
- Key learnings from the first JCAs, including evidence expectations and common challenges.
- Implications for future clinical development, from trial design to endpoint selection.
- Practical considerations for evidence generation, to better prepare for future JCA requirements and PICO expectations.
15:00
15:30
Matteo Scarabelli
- First JCAs in the orphan space: specificities and learnings
- Challenges for orphan drugs from the national perspective.
16:30
17:00
Welcome
Designing Payer-Ready Clinical Development Programme: Integrating HTA, Evidence Generation and Market Access from Day One
Coffee break
10:40
Regulatory and HTA Strategy - From Early Advice to the Parallel Preparation of Marketing Authorisation and EU HTA
Regulatory and HTA Strategy - From Early Advice to the Parallel Preparation of Marketing Authorisation and EU HTA
Carolin Knorr
- Part 1: Integration of Regulatory and HTA Advice
- Regulatory advice, (parallel) Joint Scientific Consultation, and national HTA advice - how can requests, key questions, timelines, and objectives be aligned most effectively?
Short break
11:50
Regulatory and HTA Strategy
Regulatory and HTA Strategy
Carolin Knorr
- Part 2: From Advice to Regulatory and HTA Submission
- How can the interface between Regulatory and HTA be effectively managed from the late development phase through the MAA and onwards to the JCA?
Lunch break
14:00
Learnings from the First JCAs and Implications for Future Clinical Development and Data Generation
Learnings from the First JCAs and Implications for Future Clinical Development and Data Generation
Victoria Unmüßig
- Key learnings from the first JCAs, including evidence expectations and common challenges.
- Implications for future clinical development, from trial design to endpoint selection.
- Practical considerations for evidence generation, to better prepare for future JCA requirements and PICO expectations.
Coffee break
15:30
Orphans under the JCA framework: from 2025 to 2028
Orphans under the JCA framework: from 2025 to 2028
Matteo Scarabelli
- First JCAs in the orphan space: specificities and learnings
- Challenges for orphan drugs from the national perspective.
Final discussion
Seminar end
Downloads
Request the documents using our form.
Market Access Basic Concepts
Further Informations
Technical requirements
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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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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