Pharmaceutical Regulatory Affairs in The Eu & US

Content

• Chapter 1 Introduction and Eu Overview
  • 1.1 Origins and Purposes of Regulation
  • 1.1.1 Early British Regulation
  • 1.1.2 Modern Regulation
  • 1.1.3 Development of US Regulations
  • 1.2 Basic Elements and Approaches in Regulation
  • 1.2.1 Safety
  • 1.2.2 Quality
  • 1.2.3 Efficacy
  • 1.2.4 Promotion
  • 1.3 Eu Institutions and Legislation
  • 1.3.1 Paediatric Legislation
  • 1.4 Approaches to Eu Registration
  • 1.4.1 Centralised
  • 1.4.2 Mutual Recognition
  • 1.4.3 Decentralised
  • 1.4.4 National
  • 1.5 Role of The Regulatory Affairs Professional
  • 1.5.1 Interactions within The Company
  • 1.5.2 External Interactions
  • 1.6 Conclusion
• Chapter 2 US and International Overview
  • 2.1 Introduction
  • 2.1.1 Modern Regulation
  • 2.2 US Fda Regulatory Overview
  • 2.2.1 Investigational New Drug (Ind) Application
  • 2.2.2 New Drug Application (Nda)
  • 2.2.3 Review
  • 2.2.4 Inspection
  • 2.2.5 Approval
  • 2.2.6 Maintenance
  • 2.3 US Administrative Procedure
  • 2.3.1 Emea and Fda Cooperation on Medicines Regulation
  • 2.4 Fda Good Guidance Practices
  • 2.4.1 Guidance Options
  • 2.5 Regulatory Bodies in Other Countries
  • 2.5.1 Tripartite Agreement
  • 2.5.2 Hong Kong
  • 2.5.3 Canada
  • 2.5.4 South (or Latin) America
  • 2.5.5 African Countries
  • 2.5.6 Australia and New Zealand
• Chapter 3 Product Development
  • 3.1 New Product Development
  • 3.1.1 Steps Involved in Product Development
  • 3.1.2 Attrition Rate for Drugs Selected for Development
  • 3.2 Introduction to The International Conference on Harmonisation (Ich)
  • 3.2.1 How Did Ich Come about?
  • 3.2.2 The Beginnings of Ich
  • 3.3 Pre-Clinical Studies
  • 3.3.1 What Is Toxicity?
  • 3.3.2 Guideline for Toxicity Studies before Clinical Studies (Phase I) in Healthy Volunteers:
  • 3.3.3 Reproductive Toxicology
  • 3.3.4 Mutagenicity Studies
  • 3.3.5 Conventional Carcinogenicity Studies
  • 3.4 Good Laboratory Practice (Glp)
  • 3.4.1 What Is Glp?
  • 3.5 Clinical Trials and Good Clinical Practice
  • 3.5.1 So What Is A Clinical Trial?
  • 3.5.2 Post-Marketing Surveillance (Pms) Studies
  • 3.5.3 What Is Good Clinical Practice?
  • 3.6 Eu Clinical Trials Directive
  • 3.6.1 Clinical Trials Directive (2001/20/Ec)
  • 3.6.2 What Regulatory Documentation Is Required for A Clinical Trial Application in The Eu?
  • 3.6.3 Regulatory Documents Required for A Clinical Trial Application in Eu Member States
  • 3.7 Eu Privacy Legislation
  • 3.8 Fda Clinical Trials Regulation
  • 3.8.1 Organisation
• Chapter 4 Applications for Marketing Authorisations: General Approach
  • 4.1 Ich Common Technical Document
  • 4.1.1 Introduction
  • 4.1.2 The Ctd
  • 4.1.3 High-Level Structure of Module 1 and The Ctd Modules 2, 3, 4 &
  • 4.1.4 Presentation of The Application
  • 4.2 Eu and US: Similarities and Differences
  • 4.3 Quality (Cmc)
  • 4.4 Safety
  • 4.4.1 Module 2: Overview and Summaries
  • 4.4.2 Guidance Notes
  • 4.5 Efficacy
  • 4.5.1 The Clinical Overview
  • 4.5.2 Structure of Module
  • 4.6 Product Maintenance
  • 4.6.1 Variations
  • 4.6.2 Renewals
  • 4.6.3 Withdrawals
  • 4.7 Other Considerations
• Chapter 5 Regulation of Generics and Innovator Rights
  • 5.1 Generic Medicines
  • 5.1.1 What Is A Generic?
  • 5.1.2 Pricing of Generics
  • 5.1.3 Licensing A Generic Product
  • 5.2 Intellectual Property Law
  • 5.2.1 Patent Protection
  • 5.2.2 Patent Expiration
  • 5.2.3 Patent Challenge
  • 5.2.4 Data Exclusivity
  • 5.2.5 The Bolar Clause in The Eu
  • 5.2.6 The US 180-Day Generic Drug Product Exclusivity
  • 5.2.7 Data Protection
  • 5.2.8 Other Types of IP Protection
  • 5.3 Supplementary Protection Certificates
  • 5.3.1 What Is An Spc?
  • 5.3.2 The Need for Spcs in The Eu
  • 5.3.3 Obtaining and Maintaining Spcs
  • 5.4 US Patent Term Restoration
  • 5.4.1 Length of Patent Term Restoration
  • 5.4.2 Applying for A Patent Extension
  • 5.4.3 Determining The Length of The Patent Extension
  • 5.5 Parallel Trade Issues
  • 5.5.1 Parallel Trade in The Eu
  • 5.5.2 Parallel Trade in The US
  • 5.5.3 Counterfeiting of Medicinal Products
  • 5.5.4 Products Traded over The Internet
• Chapter 6 over-The-Counter Drugs, Herbals & Homoeopathics
  • 6.1 over-The-Counter Drugs
  • 6.1.1 Introduction
  • 6.1.2 What Is An Otc Drug?
  • 6.1.3 The '2001 Review'
  • 6.1.4 Advertising and Branding
  • 6.1.5 Safety Assessment for Pom to P Switches
  • 6.1.6 What Is Involved in The Reclassification of Medicines from Pom to P?
  • 6.1.7 Switching from Pom to P
  • 6.1.8 Other Considerations
  • 6.1.9 Data Requirements
  • 6.1.10 Product Information
  • 6.1.11 Other
  • 6.1.12 US Otc
  • 6.1.13 Drug Interactions
  • 6.2 Herbal Medicines
  • 6.2.1 Eu Legislation
  • 6.2.2 Why Is There A Change in The Legislation with Respect to Herbal Medicines?
  • 6.2.3 An Example of An Eu Herbal Medicines Registration Scheme: Mhra
  • 6.2.4 Product Information: Labelling and The User Package Leaflet
  • 6.2.5 Advertising
  • 6.2.6 Pharmacovigilance
  • 6.2.7 US Legislation
  • 6.3 Homeopathy
  • 6.3.1 What Is Homeopathy?
  • 6.3.2 Homeopathic Preparations
  • 6.3.3 Use of Homeopathy around The World
  • 6.3.4 Homeopathic Legislation in The Eu
  • 6.3.5 Homeopathy in The US
• Chapter 7 Biologicals, Gene Therapy and Other Special Categories
  • 7.1 Biologicals, Biotechnology and Biosimilars
  • 7.1.1 Biologicals
  • 7.1.2 The History of Biotechnology
  • 7.1.3 Types of Biological Products
  • 7.1.4 Licensing A Biological Product
  • 7.1.5 Biosimilars
  • 7.2 Blood and Blood Products
  • 7.2.1 Introduction to Blood and Blood Products
  • 7.2.2 Eu Blood Legislation
  • 7.2.3 US Blood Legislation
  • 7.2.4 Registering A Blood Product
  • 7.3 Gene Therapy and Cloning
  • 7.3.1 Gene Therapy
  • 7.3.2 Cloning
  • 7.3.3 Regulation of Cloning
  • 7.4 Other Special Categories
  • 7.4.1 Radiopharmaceuticals
  • 7.4.2 Nutraceuticals
• Chapter 8 Safety, Quality and Regulation
  • 8.1 Labelling of Medicinal Products
  • 8.1.1 Introduction to Labelling
  • 8.1.2 Eu Labelling Requirements
  • 8.1.3 US Labelling Requirements
  • 8.2 Pharmacovigilance
  • 8.2.1 Introduction to Pharmacovigilance
  • 8.2.2 When Does Pharmacovigilance Begin?
  • 8.2.3 What Information Is Collected?
  • 8.2.4 What Happens to The Collected Data?
  • 8.2.5 Changes to An Ma as A Result of Pharmacovigilance
  • 8.2.6 Periodic Safety Update Reports
  • 8.2.7 Content of A Psur
  • 8.2.8 Dear Dr Letters
  • 8.2.9 Reporting of Suspected Adverse Drug Reactions in The Eu
  • 8.2.10 Reporting of Suspected Adverse Drug Reactions in The US
  • 8.2.11 Black Triangle
  • 8.3 Ensuring The Quality of Medicinal Products
  • 8.3.1 Introduction to Quality
  • 8.3.2 Counterfeit Products
  • 8.3.3 Defective Products
• Chapter 9 Advertising and Marketing Practices
  • 9.1 The Role of The Pharmaceutical Industry in Promotion and Medical Education
  • 9.1.1 Introduction to The Promotion of Medicines
  • 9.1.2 Looking after The Consumer
  • 9.1.3 Defining Promotion
  • 9.1.4 Eu Legal Requirements
  • 9.1.5 Differences and Similarities between Countries and Regions in The Regulation of Advertising/Promotional Material
  • 9.2 Organisations Responsible for Monitoring Promotional Activities around The World
  • 9.2.1 Introduction
  • 9.2.2 Global Organisations
  • 9.2.3 European Organisations
  • 9.2.4 UK Organisations
  • 9.2.5 US Organisations
  • 9.3 Compliance Strategies
  • 9.3.1 Compliance Strategies in The US
  • 9.3.2 California Law
  • 9.3.3 Compliance Strategies in The Eu
• Chapter 10 Other Eu and US Regulations
  • 10.1 Paediatric Medicines Legislation
  • 10.1.1 The Need for Legislation
  • 10.1.2 Legislation in The Eu
  • 10.1.3 Legislation in The US
  • 10.2 Risk Management
  • 10.2.1 Introduction to Risk Management
  • 10.2.2 Risk Management outside of The Eu
  • 10.3 Regulation of Combination Products
  • 10.3.1 US Approach
  • 10.3.2 Eu Approach
  • 10.4 Medicare and Medicaid
  • 10.4.1 Medicare
  • 10.4.2 Problems Facing Medicare
  • 10.4.3 Medicaid
  • 10.5 Core Competencies of A Rap
  • 10.5.1 Introduction
  • 10.5.2 Key Core Competencies
• List of Tables
  • Table 1.1 The Changing Options Available to Applicants Intending to Register A Medicinal Product in The Eu
  • Table 2.1 The Scope of Fda Good Guidance Practices
  • Table 3.1 Examples of Product Failure Rates as They Move through Developments
  • Table 3.2 Reasons for Terminating A Product in Development
  • Table 3.3 Chronological Events in The History of Ich
  • Table 3.4 Guidance for Toxicity Studies (Time of Exposure) before Clinical Trials in Patients: Ich M3
  • Table 3.5 Toxicology Data to Support Phase Iii Trials in Eu
  • Table 3.6 The Phases of Clinical Development
  • Table 3.7 Guidance for Patient Privacy Rights
  • Table 4.1 General Differences between The Eu and US Applications
  • Table 4.2 Module 3: Quality
  • Table 4.3 Module 3: Ctd Organisation
  • Table 4.4 General Guidelines
  • Table 4.5 Active Substance Guidelines
  • Table 4.6 Medicinal Product Guidelines
  • Table 4.7 Module 4: Non-Clinical
  • Table 4.8 Relevant Pharmacokinetic Documents
  • Table 4.9 Relevant Toxicology Documents
  • Table 4.10 General Guidelines
  • Table 4.11 General Efficacy Clinical Safety
  • Table 4.12 Clinical Pharmacology
  • Table 5.1 Brufen (Ibuprofen) and Its Associated Generic Versions
  • Table 5.2 Market Protection for An Originator's Theoretical Product in The Eu
  • Table 6.1 Eu Member States and The Implementation of Articles 16(1) or 16(2)127
  • Table 9.1 Type of Regulation and Legal Requirements for Advertising of Medicines
  • Table 10.1 Overview of The Eu Risk Management Plan Template Produced by The Emea
  • Table 10.2 Core Competencies Required by A Rap