Regulatory Intelligence as the Basis for Regulatory Strategy and Global Drug Development

Table of Contents

• LIST OF ABBREVIATIONS
• INTRODUCTION
• COMPONENTS OF REGULATORY INTELLIGENCE
  • COMPETITOR INFORMATION
    • Criteria for the definition of relevant competitors
    • Essential information to be gathered about competitors.
      • International Non-proprietary Name (INN)
      • Trade name
      • Countries and the associated Submission date / Approval date
      • Clinical trials presented in the dossier
      • Drug class
      • Type of Procedure
      • Competitor labelling
    • Sources of Competitor Information
      • Authority Homepages
      • Company Homepages
      • Scientific Publications
      • Scientific Internet Search Engines
      • General Internet Search Engines
      • Labelling Databases
  • REGULATORY ENVIRONMENT
    • Agency Benchmarks
      • FDA
      • EMEA
      • Germany
      • France
      • Conclusion
    • Review 2001 (Europe)
    • EU Enlargement
    • Regulatory Precedents on Other Products
    • Ongoing and Future Regulatory Changes
      • Implementation of the Clinical Trial directive (Directive 2001/20/EC)
      • Implementation of the CTD structure for Dossiers
    • Trade Associations
      • VFA
      • EFPIA
      • JPMA
      • PhRMA
      • IFPMA
    • Regulatory Associations
    • WHO
    • Training courses and Meetings
  • LEGAL REQUIREMENTS
    • General Requirements
      • Supra-national Guidance - Example: ICH
      • Europe
      • Japan
      • USA
    • Therapeutic Area Guidance - Example: Microbial Diseases
    • Special Populations - Example: Paediatric Patients
    • Orphan Drug Designation
• REGULATORY STRATEGY
  • DEFINITION OF “GLOBAL REGULATORY STRATEGY”
  • REGULATORY AFFAIRS STRATEGIC CONTRIBUTIONS TO THE GLOBAL MULTIDISCIPLINARY DEVELOPMENT PLAN
    • Competitor Analysis and Target Labelling
    • Definition of Trade Name and INN
    • Definition of Key Markets
    • Definition of a Clinical Development Plan
    • Identification and Validation of Relevant Guidelines
    • Life Cycle Management Strategy
  • REGULATORY STRATEGY AND IMPACT ON OTHER DISCIPLINES
    • Submission Strategy
    • Strategy for Meetings with Health Authorities
    • Issue Management
• DISCUSSION
• REFERENCES

Objectives and Key Themes

The document examines the critical role of Regulatory Intelligence in shaping successful global drug development strategies. It explores how Regulatory Intelligence enables effective drug development planning and execution, ultimately leading to approval and market success.

• The importance of Regulatory Intelligence in global drug development
• The components and sources of Regulatory Intelligence information
• The impact of regulatory intelligence on strategic considerations
• The interdisciplinary nature of drug development and the role of Regulatory Affairs
• Strategies for gathering competitor information and analyzing the regulatory environment

Chapter Summaries

The document delves into the key aspects of Regulatory Intelligence, including its sources and applications. It analyzes competitor information, regulatory environments, and legal requirements, highlighting their impact on drug development strategies. The chapter on “Regulatory Strategy” explores the definition and implementation of a global regulatory strategy, highlighting its impact on various disciplines involved in drug development, such as clinical trials, submissions, and interactions with health authorities.

Keywords

The primary focus of this document is on Regulatory Intelligence and its application in global drug development. Key terms include Regulatory Affairs, regulatory strategy, competitor analysis, regulatory environment, legal requirements, clinical development plan, submission strategy, and interactions with health authorities.