9781782622222

1782622225

9781788014045

1788014049

9781782620662

Issues in toxicology ; 36

Cover; Regulatory Toxicology in the European Union; Preface; Contents; Chapter 1

Introduction and General Aspects of Risk Assessment; 1.1 History of Regulation in the European Union (EU); 1.2 Philosophical Aspects of Risk; 1.3 Types of Regulatory Regime; 1.4 Quality of Data; 1.4.1 Proprietary Data Versus Studies in the Peer-reviewed Literature; 1.4.2 Proprietary Data; 1.4.2.1 Good Laboratory Practice; 1.4.2.2 Guidelines; 1.4.3 Data from the Peer-reviewed Literature; 1.4.4 Human Data; 1.5 Expertise; 1.6 General Aspects of Risk Assessment; 1.6.1 Derivation of Standards

1.6.1.1 Uncertainty (Safety) Factors (UFs)1.6.1.2 New Developments in Risk Assessment; 1.6.2 Standards; 1.6.2.1 Prohibition of Use; 1.6.2.2 Maximum Residue Limits or Levels (MRLs); 1.6.2.3 ALARA; 1.6.2.4 Limit of Quantification; 1.6.2.5 Ranges; 1.6.2.6 Standards for Air Pollutants; 1.6.3 Risk Management; 1.7 Conclusions; Acknowledgements; References; Chapter 2

Regulation of Medicinal Products for Human Use in the European Union; 2.1 Introduction; 2.2 What Are Medicinal Products for Human Use?; 2.3 Background to the Legislation; 2.4 EU Legislation

2.5 Legislation: Differences Between Regulations, Directives and Guidelines2.6 The EU Regulatory System for Medicinal Products; 2.7 European Medicines Agency (EMA): Role, Tasks and Functioning; 2.8 EMA: Scientific Committees; 2.8.1 Committee for Medicinal Products for Human Use (CHMP); 2.8.2 The Pharmacovigilance Risk Assessment Committee (PRAC); 2.8.3 The Committee for Orphan Medicinal Products (COMP); 2.8.4 The Committee on Herbal Medicinal Products (HMPC); 2.8.5 The Committee for Advanced Therapies (CAT); 2.8.6 The Paediatric Committee (PDCO); 2.9 Composition of Committees

2.10 Scientific Guidelines2.11 Marketing Authorisation Procedures; 2.11.1 Centralised Procedures; 2.11.2 Support for Early Access to Medicines; 2.11.3 Accelerated Assessment; 2.11.4 Conditional Marketing Authorisation; 2.11.5 Exceptional Circumstances Authorisation; 2.11.6 Compassionate Use; 2.11.7 PRIME (PRIority MEdicines) Scheme; 2.12 Decentralised Procedure (DCP); 2.13 Mutual Recognition Procedure (MRP); 2.14 National Authorisation Procedures; 2.15 Special Procedures; 2.15.1 Article 58 Applications; 2.15.2 Compassionate Use; 2.16 Referral Procedures; 2.17 Data Submission on Medicines

2.18 Scientific Assessments2.19 Adopting a Committee Opinion or Recommendation; 2.20 Transparency; 2.21 European Public Assessment Reports (EPARs); 2.22 Standing and Temporary Working Parties; Scientific Advisory Groups; Other CHMP-associated Groups; 2.22.1 The Safety Working Party (SWP); 2.22.2 The Scientific Advice Working Party (SAWP); 2.22.3 The Biologics Working Party (BWP); 2.22.4 The Joint Committee for Medicinal Products for Human Use/Committee for Medicinal Products for Veterinary Use Quality Worki ... ; 2.22.5 Healthcare Professionalsâ#x80;#x99; Working Party (HCPWP)

2.22.6 Patientsâ#x80;#x99; and Consumersâ#x80;#x99; Working Party (PCWP)

Toxicology > European Union countries.