FDA Regulation in Entrepreneurship and Clinical Research Session 12: Post-marketing Issues

The FDA Regulation in Entrepreneurship and Clinical Research course is designed to provide foundational knowledge in the FDA approval and regulatory process while highlighting scientific, clinical, ethical, and other related emergent factors for consideration. The course includes a series of lecture-based sessions delivered by content experts and interdisciplinary team-based learning discussions of case studies. Participants will also go through the process of reviewing an example Investigational New Drug (IND) or Investigational Drug Exemption (IDE) Application and preparing an IND or IDE for submission with the guidance of nationally renowned experts in FDA regulation and law. The primary goal of this course is that upon completion, participants will be able to take the knowledge gained from content experts and apply it to facilitate the movement of their current or future technologies through the FDA approval process.

Tuesday, April 11, 2023, 4:00 PM - 6:00 PM, Online, Cleveland, OH

1. Summarize the history of the FDA and the agency’s mission.
2. Describe the FDA drug approval process and important factors that must be considered during the process as an investigator.
3. Distinguish between the different routes for FDA product approval.
4. Identify the key principles for ethical human clinical testing.
5. Examine and apply the importance of design elements required in a clinical trial by the FDA.
6. Compare and contrast biological product issues specifically regarding vaccines, single cell production and gene therapy.
7. Describe ethical considerations related to generic medications.
8. Specify issues regarding FDA enforcement and post-marketing studies.
9. Compare and contrast the FDA device, diagnostic, and diagnostic sensor approval process with the approval process for other technologies discussed during the course.
10. Formulate an appropriate recommendation following a mock IND or IDE application review.
11. Synthesize the cumulative knowledge gained to prepare an IND or IDE application taking into account the important considerations relevant to the technology chosen.

Case Western Reserve University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

AMA PRA Category 1 Credits™ (2.00 hours), Non-Physician Attendance (2.00 hours)

Mitigation of Relevant Financial Relationships

CWRU School of Medicine adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CE activity, including faculty, planners, reviewers or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.