Overview of our services in the field of non-randomised studies and indirect comparisons Strategic consulting Systematic research Study design consulting Statistical consulting Non-randomised studies and non-adjusted indirect comparisons in benefit assessments Benefit assessments, at EU level as well as full assessments in Germany, are used to compare the efficacy and safety of a health
Overview of our services Strategic advice Regulation (EU) 2021/2282 Article 7 (1) of Regulation (EU) 2021/2282 specifies when a health technology must undergo a Joint Clinical Assessment (JCA). Paragraph 1a stipulates that the time of initial market authorization application (MAA) is decisive. A JCA of the new health technology only needs to be
EUnetHTA21 offers early dialogue Joint Scientific Consultations (JSC) in parallel to the EMA scientific advice for medicinal products which are to undergo the EU Joint Clinical Assessments starting in 2025. In 2022, five JCS slots are available. Health technology developers can apply for a JCS during the open call from June 6 to August 31,
The first medicinal products used to treat oncologic diseases and ATMPs will be assessed within the framework of the Joint Clinical Assessments on the level of the European Union (EU) starting in 2025. Until then, the necessary health technology assessment (HTA) process needs to be defined and refined. Today, we were honored to present our
The Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment (HTA) and amending Directive 2011/24/EU is effective starting today, 11 January 2022. Click for more information>>> The Regulation aims to establish joint clinical assessments of health technologies in the European Union (EU) starting with oncologic
On Dec 13th, 2021, the Regulation on Health Technology Assessment (HTA) has officially been adopted. The new Regulation aims to establish a system for joint clinical assessments of health technologies in the European Union. First assessments of oncologic drugs and ATMPs start in 2025, followed by orphan drugs three years later in 2028 and medicinal
This month, the European Council adopted the regulation on the EU-wide assessment of health technologies (EU-HTA). At the same time, the first call for applications is now open for scientific advice within the framework of EUnetHTA. In the open call of the EUnetHTA 21 JSC Secretariat, pharmaceutical companies can apply for parallel consultations with the
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