Understanding the regulatory underpinnings related to the conduct of clinical trials serves to support compliance with applicable laws and promote efficient negotiation. This program is intended to describe the standards, regulations and requirements that are, or should be, addressed in contracts for the conduct of clinical trials to support FDA applications.
Tipo de evento: Educación legal continua/desarrollo profesional continuo, Seminario web
- Fecha/hora de inicio:
- 11 July 2018, 12:00 PM EDT
- Fecha/hora de finalización:
- 11 July 2018, 1:00 PM EDT
- Enlace de registro:
- Click here to register for this webinar.
The speakers will also address the various FDA and health care laws commonly referenced in clinical trials contracts and discuss fraud and abuse considerations related to clinical trial contracts and investigator-initiated study grant contracts, including the Anti-Kickback Statute, as well as transparency laws related to the same, such as the federal Sunshine Act.
This program is presumptively approved for 1.0 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. For lawyers licensed in New York, this course is eligible for 1.0 credit under New York’s Approved Jurisdiction Policy. Please allow four weeks after the program to receive a certificate of attendance.