INTRODUCTION
Clinical trials must be conducted with a high degree of regulation and legislation. This course is designed to familiarize candidates with the legal and ethical principles that form the basis for the modern organization. The course will cover comparative legislation by examining the current legal systems of different countries. The fundamental dimension of ethics will also be covered describing contextual significance of ethical issues in relation to clinical research.
PROGRAM OBJECTIVES
- Learning the fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA) Processes
- Carrying out NDA preparation
- Understanding prescription drug labeling
- Understanding post-marketing requirements
WHO SHOULD ATTEND?
- Regulatory affairs professionals
- Clinical research and development professionals
- Researchers
- Quality and manufacturing professionals
- Medical writers
- Clinical Business Development professionals
- Project Managers
- Those who intend to expand their understanding of ethical and regulatory considerations within the scope of clinical research
PROGRAM OUTLINE
- Introduction to regulatory affairs
- Intellectual property management
- Know about the regulatory strategy into the drug development plan
- Identify requirements for IND/NDA in the Common Technical Document (CTD) Format
- Plan and prepare an IND/NDA, and know the reporting requirements for IND/NDA amendments
- Regulatory aspects in pharmacovigilance
- Regulations governing clinical trials & new drugs
- Define NDA post-approval responsibilities and requirements
- Identify regulatory mechanisms to facilitate development of new therapies
- Report adverse events in accordance with current FDA or European regulations
- Regulatory aspects in pharmacovigilance
- Apply formal meeting principles and practices when interacting with the FDA and European regulations
- Outline the regulatory requirements for prescription drug labeling
- Global drug policy & patent aplications
- Orphan drugs
- Manufacturing requirements for investigational products
- Clinical investigator inspections
- International inspections
- Electronic data
Permintaan Brosur penawaran Training
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