RAC Devices Exam Prep 2024 Questions and Answers Correct
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Course
RAC Devices
Institution
RAC Devices
RAC Devices Exam Prep 2024 Questions and Answers Correct
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 don...
RAC Devices Exam Prep 2024 Questions and Answers Correct Who is the Europ ean 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 bodie s 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 -Evalu ate 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 c ore 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' et hical responsibilities. medicinal product advertising and promotion (#) - Answer ✔️✔️-EU Directive 2001/83 /EC Six (6) basic principles in EU Directive 2001/83/EC - Answer ✔️✔️-1. medicines without a market authorisation shall not be advertised 2. no off -label indications advertising 3. advertising of a medicine must comply with the specifics in the summary of product char - acteristics (SmPC) 4. advertising of a medicine shall encourage the rational use of the product by an objective pre - sentation and shall not be misleading 5. prescription medicines may only be advertised to HCPs with the qualifications to prescribe or supply them 6. OTC medicines may be advertised to the gen - eral public, subject to certain rules.
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