RAC Devices Exam Prep (Fall2021/2023)

Who is the European Medicines Agency (EMA) - ANSWER-an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. The primary reason for establishing EMA was to harmonise the work being done by the individual regulatory bodies in Europe. Relevance of EMA in EU - ANSWER-founded in 1995, working across the EU to protect human and animal health by assessing medicines to rigorous scientific standards and by providing partners and stakeholders with independent, science-based informa tion on medicines Mission of EMA - ANSWER--Facilitate dev and access to medicines -Evaluate applications for marketing authorisation -Monitor safety of meds -Provide info on human and vet meds to professionals and patients New Approach (EU) - ANSWER-The basic concept is including Essential Requirements for safety and performance in the core legal text and publishing the technical specifications in harmonised standards. Other def: A innovative regulatory technique tha includes mandatory Essential requirements, conformity assessment procedures and CE marking. 1990s, New Approach (impact on MDs) - ANSWER-EU regulations relating to medical devices' safety and performance were harmonised in the ____(date) _, following the _____ _____ legislative principles. AIMDD (# and date) - ANSWER-Council Directive 90/385/ EEC, 20 June 1990 MDD (# and date) - ANSWER-Council Directive 93/42/EEC, 14 June 1993 IVDD (# and date) - ANSWER-Directive 98/79/EC of the European Parliament and of the Council, 27 October 1998 key historic developments influencing today's EU healthcare regulations - ETHICS - ANSWER-the Nuremberg Code, was drafted in 1947. The Helsinki Declaration of 1964 further developed the Nuremburg Code's principles, and tied them to the Declaration of Geneva (1948), an internationally acknowledged statement of physicians' ethical responsibilities. medicinal product advertising and promotion (#) - ANSWER-EU Directive 2001/83/EC