IFAPP – HTA REQUIREMENTS IN RELATION TO THE EU REGULATION Webinar
A German Perspective
June 8th, 2023
2:00 pm – 3:00 pm CET
Speaker
Dr. Stephanie Said
Scientific Advisor, Senior Project Manager
Head of EUnetHTA 21 JSC Secretariat
The Federal Joint Committee
Gemeinsamer Bundesausschuss (G-BA)
TOPIC:
The REGULATION (EU) 2021/2282 OF
THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL of 15 December
2021 on health technology
assessment and amending Directive
2011/24/EU (Text with EEA
relevance) sets out the frame for
cooperation of national Health
Technology Assessments.
How does it work? Which kind of impact has the new regulation on the national decision making?
Which steps are taken to reach the goal of a harmonised approach to a European Assessment?
Dr. Said will give an in-depth information about the involvement of Germany in the development
of the process, the steps already taken e.g. by EUnetHTA 21 and the perspectives of the
implementation of the regulation.
G-BA
The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) is the highest decisionmaking
body of the joint self-government of physicians, dentists, hospitals and health insurance
funds in Germany.
The G-BA must put every new active pharmaceutical ingredient through an early benefit
assessment within six months after it is launched on the German market. During the early
benefit assessment, the G-BA examines whether the drug is really something new: if it offers
patients greater benefit than comparable treatments that are already available.
REGISTRATION
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