CRC 202 - Investigational Product Development and Regulation

1. Explain the Investigational Products Development Process
2. Describe the roles and responsibilities of those involved in the Investigational Products Development Process
3. Explain the purpose of pharmacovigilance
4. Summarize the methods of safety monitoring
5. Describe the management and training approaches to mitigate risk

1. Analyze case studies and current events to appreciate ongoing issues & concerns
2. Apply applicable laws, regulations, and guidelines to recommend possible solutions

1. Introduction to the Drug Development Process
   1. Key elements of a drug development project
   2. Role of various personnel involved
   3. Basics of project management skills and their use in clinical projects
   4. Current status of biomedical industry and future trends
   5. Government and non-government agencies involved in regulating medical products and life cycle
   6. Steps from Research & Development to post-marketing
2. Introduction to Food and Drug Administration (FDA) Regulatory Process
   1. US FDA vs. international regulators
   2. Overview of FDA
      1. Organization and responsibilities
      2. Laws, regulations, guidance
   3. FDA applications (IND, IDE, NDA, BLA, etc.)
   4. Fees for FDA review
   5. FDA enforcement processes
      1. Audits
      2. Documents  
      3. Warning letters
      4. Penalties
      5. Interaction with FDA
3. Clinical Trial Applications
   1. Clinical trial approval applications
      1. Investigational New Drug (IND)
      2. Investigational Device Exemption (IDE)
   2. Key components of clinical trial approval applications
   3. Basic principles of Good Lab Practices (GLP)
   4. Basic principles of Good Manufacturing Practices (GMP)
   5. Logistics of an FDA application review process and its role in the clinical project planning
4. Good Clinical Practices (GCP)
   1. US and international standards for conduct of clinical trials
   2. Roles and responsibilities of various personnel involved in clinical trials (physicians, nurses, pharmacists, ethicists, advertisers, and investors)
   3. FDA Audits
   4. Bioresearch Monitoring Board
5. Adverse Event Management in Clinical Trials
   1. Best practices for safety monitoring and management of adverse events in a clinical trial project.
   2. Safety reporting requirements
   3. Time-lines for reporting to regulators