Full program description
Principal Investigators and regulatory professionals must stay abreast of legal requirements and compliance strategies when conducting clinical trials. This symposium offers perspectives from attorneys and regulatory experts to discuss U.S. and international regulations for pharmaceutical, biologic and medical device organizations, as well as sponsored and investigator-sponsored trials.
This symposium is comprised of 6 sessions which review the various legal requirements for principal investigators and regulatory professionals when conducting a clinical trial, including investigator’s responsibilities, contracts, liabilities, indemnifications, invention protection, and privacy compliance. Participants earn contact hours for each session and at the completion of all 6 sessions earn a badge recognizing completion of the symposium.
- Session 1: Investigator Responsibilities: Industry Sponsor Trials
- Session 2: Investigator Responsibilities: Investigator Initiated Trials
- Session 3: Clinical Trial Contracts
- Session 4: Legal Considerations of Compassionate Use
- Session 5: Liability and Indemnification
- Session 6: Privacy and HIPAA
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