Smpc - Samenvattingen, Aantekeningen en Examens

RAC Devices Prep Exam Updated 2024 (EU) Rated A+ 1990s, New Approach (impact on MDs) - EU regulations relating to medical devices' safety and performance were harmonised in the ____(date) _, following the _____ _____ legislative principles. AIMDD (# and date) - Council Directive 90/385/ EEC, 20 June 1990 MDD (# and date) - Council Directive 93/42/EEC, 14 June 1993 IVDD (# and date) - Directive 98/79/EC of the European Parliament and of the Council, 27 October 1998 key historic deve...

RAC Devices Prep Exam Updated 2024 (EU) Rated A+ 1990s, New Approach (impact on MDs) - EU regulations relating to medical devices' safety and performance were harmonised in the ____(date) _, following the _____ _____ legislative principles. AIMDD (# and date) - Council Directive 90/385/ EEC, 20 June 1990 MDD (# and date) - Council Directive 93/42/EEC, 14 June 1993 IVDD (# and date) - Directive 98/79/EC of the European Parliament and of the Council, 27 October 1998 key historic deve...

(EU) MA - Answer-Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA - Answer-National, centralised, mutual recognition, decentralized procedures MAH - Answer-A legal person or legal entity who must be established in the European Economic Area comprising of 28 member states. What does an MA include? - Answer-Active substance international non-proprietary name, trade name. SmPC - Answer-Summary...

RAC Devices Exam Prep 2022 Questions and Answers Correct Who is the European Medicines Agency (EMA) - 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 - founded in 1995, working across the EU to protect human and animal health by assessing medicines to rigorous scientific standards and by ...

RAC Drugs Practice Exam 2024 with Questions and Answers One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additi...

Marketing and Persuasive communication; including lecture notes, chapter notes, lecture coments, practice questions and more

FA-BA113 Kruidengeneesmiddeldossier volledig. Behandeld alle onderdelen die in een kruidengeneesmiddel moeten worden wat verplicht is bij FA-BA113. Voor vragen ben ik altijd bereikbaar. Trefwoorden: smpckruidengeneesmiddelfarmacologiefarmacokinetiekwerkingsmechanismeinhoudstoffen