CRC 202 - Investigational Product Development

3 Contact Hours, 3 Credits
3 lecture periods 0 lab periods


Overview of investigational product development with attention to the legal and regulatory framework guiding drug and device safety. Includes the principles of Pharmacovigilance and Materiovigilance, including the detection, monitoring, assessment, understanding, and prevention of adverse effects associated with medicines, vaccines, biological and medical device products. Also includes how regulatory oversight supports patient safety and product integrity throughout development.

Information: Students must be admitted to or have conditional status in the Clinical Research AAS or Post-Degree Certificate program or obtain the consent of the instructor before enrolling in this course.
   

1. Outline the Investigational Product Development Process
2. Examine the management and training approaches to mitigate risk during product development
3. Interpret the purpose of pharmacovigilance and materiovigilance
4. Assess the methods of safety monitoring during development and post-market approval

1. Introduction to the Drug Development Process

   1. Key elements of a drug development project
   2. Steps from Research & Development to post-marketing
2. Application Procedures toward product approval
   1. FDA applications (IND, IDE, NDA, BLA)
   2. Fees for FDA review
   3. Review of FDA enforcement processes
3. Introduction to Device Development
   1. Discovery & Proof of Concept
   2. Preclinical - Prototype
   3. Pathway to Approval
      1. Human Factors Testing
      2. Safety Monitoring and Mitigation
   4. FDA Review
   5. Post-Marketing Safety Monitoring
4. Good Clinical Practices (GCP) applicable to product development
   1. Quality (GCP Q8R2) Pharmaceutical Development
      1. Target Product Profile
      2. Risk Assessment
      3. Design 
   2. Standards for Medical Device Development
      1. ISO 13485 
      2. CDRH Standards
   3. Good Manufacturing Practices (GCP Q7)
      1. Quality Management
      2. Personnel
      3. Building & Facilities
      4. Process Equipment
      5. Storage and Distribution
      6. Packaging Labels
      7. Good Laboratory Practices 
5. Product Safety Testing
   1. Safety Pharmacology Studies (GCP S7A)
   2. Clinical Trial Safety and Efficacy Measures
      1. Adverse Event & Risk Mitigation (GCP E6R3)
   3. Pharmacovigilance (GCP E2E)
   4. Materiovigilance 
6. Pharmacokinetics and Pharmacodynamics
   1. In Vitro & In Vivo Studies (non-clinical)
   2. Phase I Trials
   3. PK & PD relating to pharmacology