PRÓXIMAS FORMAÇÕES
Últimas Notícias
Quality documentation for medicinal products when used with a medical device- effective from 1/01/2022
This guideline describes the information that should be presented in the quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device. This guideline focuses on product-specific quality aspects of a medical device...
Artificial intelligence in medicine regulation
published by EMA News 16/08/2021 The International Coalition of Medicines Regulatory Authorities (ICMRA) sets out recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation, in...
Clinical Trial Information System (CTIS) – Sponsor Handbook
published by 28 July 2021 EMA/299895/2021 – v. 1.00 Clinical Trials Information System (CTIS) programme A compilation of key guidance, technical information, recommendations and references for getting ready for use of CTIS The aim of the EMA CTIS Sponsor...
