Smpc - Samenvattingen, Aantekeningen en Examens

RAC Drugs Final Exam 2024 | 40 Questions with 100% Correct Answers | Verified | Latest Update | Graded A+ (EU) MA - 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 - National, centralised, mutual recognition, decentralized procedures MAH - 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? - Active substance...

RAC Devices Exam Prep 2023/2024 (EU) Rated A+ 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 providing partners and...

RAC DRUGS LATEST 2023 ALREADY PASSED (EU) MA 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 National, centralised, mutual recognition, decentralized procedures MAH 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? Active substance international non-proprietary name, trade name. SmPC Summary of Product Char...

RAC DRUGS Combined Tests Questions with 100% Revised Correct Answers | Verified | Latest Update | Graded A+ (EU) MA meaning and valid for how long - 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 comp...

UR. Uitsluitend Recept. UA. Uitsluitend Apotheek. 00:05 01:33 UAD. Uitsluitend Apotheek en Drogist. AV. Algemene Verkoop. Zelfzorg. Een persoon die op eigen initiatief en eigen verantwoordelijkheid aandacht wil besteden aan het verminderen of opheffen van herkenbare/tijdelijke gezondheidsklachten. Waar staat de afkorting "CBG" voor? College ter Beoordeling van Geneesmiddelen. Zij bepalen de afleverstatus van een geneesmiddel. Verantwoorde...

ANDA - Abbreviated New Drug Application BLA - Biologics License Application CA - Competent Authority CBE - Changes Being Effected CEN - European Committee for Standardization CPP - Certificate of a Pharmaceutical Product CTD - Common Technical Document CV - Curriculum Vitae DCP - Decentralised Procedure DLP - Data Lock Point EC - European Commission EMA - European Medicines Agency EU - European UnionFDA - Food and Drug Administration GMP - Good Manufacturing Practices HA - Health A...

RAC Pharmaceuticals EU Regulations | Latest Update | 2024/2025 | Rated A+ What are Good Manufacturing Practices (GMP)? Guidelines that ensure that pharmaceutical products are consistently produced and controlled according to quality standards. What does the term "Pharmacovigilance" refer to? The science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. What is a Summary of Product Characterist...

(EU) MA - correct 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 - correct answer National, centralised, mutual recognition, decentralized procedures MAH - correct 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? - correct answer Active substance international non-proprietary na...

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 Drugs Final Exam Study Guide 2024 | 45 Questions with 100% Correct Answers | Verified | Latest Update | Graded A+ (EU) MA - 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 - National, centralised, mutual recognition, decentralized procedures MAH - 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? - Acti...