Market Access of Biosimilars in Europe
Biosimilar uptake in Europe, Aut idem and tenders in Germany
- Biosimilar uptake in Europe - how to enhance?
- Aut idem in Germany - the current rules
- Current status of authority guidances
- Officially certified according to ISO 9001 and 21001
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
Die Teilnahmegebühr beinhaltet eine Dokumentation zum Download, ein Zertifikat, den Zugang zum Learning Space sowie technische Betreuung einschließlich PreMeeting.
Buchungsdetails
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ zzgl. MwSt.
Die Teilnahmegebühr beinhaltet eine Dokumentation zum Download, ein Zertifikat, den Zugang zum Learning Space sowie technische Betreuung einschließlich PreMeeting.
Biosimilar uptake in Europe, Aut idem in Germany - these are the challenges for regulatory affairs and market access
Your speakers
Dr. Barthold Deiters
GWQ ServicePlus AG,
GERMANY
Member of Executive Board, Pharmaceuticals
Your speaker
Dr. Barthold Deiters
GWQ ServicePlus AG,
GERMANY
Member of Executive Board, Pharmaceuticals
Dr. Petra Nies
Federal Joint Committee (G-BA), GERMANY
Head of the Pharmaceuticals Department
Your speaker
Dr. Petra Nies
Federal Joint Committee (G-BA), GERMANY
Head of the Pharmaceuticals Department
Meike Madelung, MBA
IQVIA Commercial GmbH & Co.OHG, GERMANY
Senior Consultant EMEA Thought Leadership
Your speaker
Meike Madelung, MBA
IQVIA Commercial GmbH & Co.OHG, GERMANY
Senior Consultant EMEA Thought Leadership
Prof. Dr. Steven Simoens
KU LEUVEN, Leuven, BELGIUM
Senior full professor of health economics; his research and teaching interests focus on health economic aspects of medicinal products, including economic evaluations, budget…
Your speaker
Prof. Dr. Steven Simoens
KU LEUVEN, Leuven, BELGIUM
Senior full professor of health economics; his research and teaching interests focus on health economic aspects of medicinal products, including economic evaluations, budget impact analyses, cost-of-illness analyses, market access policies and incentives. He is also one of the founders of the "Market analysis of biologics and biosimilars following loss of exclusivity" (MABEL) Fund.
Dr. Sabine Vogler
Foto: @ Ettl .
The Austrian National Public Health Institute
Pharmacoeconomics Department Head
Your speaker
Dr. Sabine Vogler
Foto: @ Ettl .
The Austrian National Public Health Institute
Pharmacoeconomics Department Head
Sumir Trivedy
Sandoz International GmbH
Head of Market Access Bio & Speciality Region Europe; 18 years in Health Care Sectors working across a number of fields of innovative medicines, MedTech and Biosimilars. For…
Your speaker
Sumir Trivedy
Sandoz International GmbH
Head of Market Access Bio & Speciality Region Europe; 18 years in Health Care Sectors working across a number of fields of innovative medicines, MedTech and Biosimilars. For the past 5 years he has been Head of Market Access Region Europe at Sandoz, supporting the education of Biosimilars and how they can act as value enablers with an outlook to support long term health care sustainability.
Dr. Elena Wolff-Holz
BIOCON, GERMANY
Chief Medical Officer
Your speaker
Dr. Elena Wolff-Holz
BIOCON, GERMANY
Chief Medical Officer
What to Expect
- Biosimilars markets in Europe: Navigating market access barriers
- Demand-side measures to ensure biosimilar uptake in Europe
- Aut idem in Germany - the current rules
- Tenders including Biosimilars
- Regulatory update Biosimilars - current status of authority guidances
Who Should Attend
This training course is aimed at regulatory affairs and market access specialists in the pharmaceutical industry who bring biosimilar products to the market. It is also of value to all those working in health insurance companies dealing with pharmaceuticals in their work.
Objective of the Event
This training course provides comprehensive insights into the European biosimilars landscape. Participants will gain a deep understanding of current market dynamics, regulatory frameworks, and access strategies across Europe, with a special focus on recent developments in Germany.
By the end of this course, you will be equipped with practical knowledge of regulatory and market access pathways for biosimilars in Europe and know how the new rules in Germany affect your market access and healthcare management.
Your Benefit
- Biosimilars in Europe - current strategies to enhance the uptake
- Aut idem in Germany - how the biosimilar business is changing here
- Current status of authority guidances and the impact on regulatory affairs
Programme
09:00-17:00 CE(S)T
Prof. Dr. Steven Simoens
Meike Madelung, MBA
Dr. Sabine Vogler
- Biosimilar substitution, prescription guidelines and quotas, gainsharing and further measures: Overview of 32 European countries and case studies
- Impact on uptake of biosimilars: Findings from the AUGMENT project
Dr. Petra Nies
Dr. Barthold Deiters
Sumir Trivedy
- Biosimilar substitution regulation in Germany compared to other EU countries
- Best practice policy measures to achieve a sustainable Biosimilar health care environment
Dr. Elena Wolff-Holz
- Fostering Biosimilars development, the regulatory landscape (Europe, the US and worldwide)
Opening address
Key note: Biosimilar markets in Europe: Navigating market access barriers and sustainability challenges
Short Break
The European Biosimilars market: trends, dynamics and opportunity
Coffee break
Demand-side measures to ensure biosimilar uptake in Europe and its impact
Demand-side measures to ensure biosimilar uptake in Europe and its impact
Dr. Sabine Vogler
- Biosimilar substitution, prescription guidelines and quotas, gainsharing and further measures: Overview of 32 European countries and case studies
- Impact on uptake of biosimilars: Findings from the AUGMENT project
Lunch break
Aut idem in Germany - the rules specified in the Pharmaceuticals Directive (AM-RL) of the Federal Joint Committee (G-BA)
Short break
Tender including Biosimilars in Germany
Biosimilar substitution in the EU - status quo, challenges and regulation framework: An industry perspective
Biosimilar substitution in the EU - status quo, challenges and regulation framework: An industry perspective
Sumir Trivedy
- Biosimilar substitution regulation in Germany compared to other EU countries
- Best practice policy measures to achieve a sustainable Biosimilar health care environment
Coffee break
Regulatory update Biosimilars - current status of authority guidances
Regulatory update Biosimilars - current status of authority guidances
Dr. Elena Wolff-Holz
- Fostering Biosimilars development, the regulatory landscape (Europe, the US and worldwide)
Conference end
Downloads
brochure
All details and content at a glance.
Market Access Concepts
Market Access Concepts
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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
e-Learning - Click and learn
We provide flexible education and training with high-quality e-Learning programmes for several topics.
List of abbreviations pharma & healthcare
Many abbreviations are used in pharma & healthcare. Download the list of the most important ones.
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
Your Contact Person
We are happy to advise you personally and individually.
Dr. Henriette Wolf-Klein
Bereichsleiterin Pharma & Healthcare
+49 6221 500-680
h.wolf-klein@forum-institut.de