Part 1: General Topics

• The Common Technical Document - a global format for registration files
• The electronic CTD (e-CTD)
• Module 1 of the CTD
• Environmental risk assessment

Part 2: CTD Summaries

• The Quality Overall Summary
• The Nonclinical Overview and Summary
• The Clinical Overview and Summary

Part 3: Quality Topics

• Drug Substance - General Information
• Drug Substance Manufacture
• Drug Substance Characterisation
• Control of Drug Substance
• Drug Substance and Drug Product- Container/Closure
• Drug Product- Description and Composition
• Drug Product - Pharmaceutical Development
• Drug Product - Manufacture and Process Validation
• Drug Product - Excipients
• Control of Drug Product
• Reference Standards or Materials
• Drug Substance and Drug Product Stability
• Viral and TSE Requirements
• Pharmaceutical Quality Systems

Part 4: Nonclinical

• Nonclinical Testing Strategy
• Pharmacology
• Pharmacokinetics and Toxicokinetics
• Single and repeat dose toxicity
• Genotoxicity
• Carcinogenicity
• Reproductive and Development Toxicity
• Safety pharmacology
• Phototoxicity
• Immunotoxicology
• Local tolerance and other toxicity studies

Part 5: Clinical Topics

• Bioavailability and Bioequivalence Studies
• Pharmacokinetics
• Pharmacodynamics
• Biostatistics: Design and Analysis of Clinical Studies
• Efficacy and Safety Clinical Studies
• Post-marketing evaluation
• Pharmacovigilance and risk management
• Studies in pregnancy and children
• Studies in the elderly
• Good Clinical Practice
• Prevention and detection of fraud in clinical trials
• Other Topics
• Biological and Biotechnology Products
• Device Drug Combination Products
• Nonclinical safety assessment of nanomedicines
• Modelling and medical product R&D Other

• Annex 1: List of acronyms and abbreviations
• Annex 2: List of key technical and regulatory information sources- published information, websites etc.

Anthony Cartwright is a freelance Pharmaceutical Regulatory Consultant, Herts, UK. He is the author or co-author of three books, three book chapters, and over twenty journal articles. He is a member of Royal Pharmaceutical Society of Great Britain, Joint Pharmaceutical Analytical Group, Association of Pharmaceutical Scientists, Drug Information Association, and the Organisation for Professionals in Regulatory Affairs. Dr. Cartwright’s former positions include Director of Global Regulatory Solutions Ltd; Regulatory Affairs Advisor; Senior Director of World-wide Regulatory Affairs, PAREXEL International Ltd.; and Director Worldwide Regulatory Affairs, PAREXEL International Ltd, among others.

Brian R. Matthews is Senior Director, EC Registration, Alcon Laboratories (UK) Ltd, and Authorised Representative under the Medical Device Directives, UK. He is a fellow of Royal Pharmaceutical Society of Great Britain and the Organisation for Professionals in Regulatory Affairs. Dr. Matthew is a member of the Drug Information Association, the Pharmaceutical Quality Group, the Joint Pharmaceutical Analysis Group, and the Industrial Pharmacists Group, Royal Pharmaceutical Society. He has written numerous journal articles and has contributed to six books. Dr. Matthews also serves on the editorial boards of the Regulatory Affairs Journal, the Regulatory Affairs Journal (Devices), and the European Journal of Parenteral Sciences.