Clinical Trials and Human Research: Complying With New Regulatory Obligations
Navigating New Requirements for Informed Consent, Disclosures, Data-Sharing, and More
Recording of a 90-minute CLE webinar with Q&A
This CLE webinar will provide guidance to counsel for navigating regulatory changes for clinical trials and human research. The panel will examine the practical impact for those sponsoring and conducting clinical trials and will outline compliance strategies to meet the new requirements.
- Regulatory landscape for clinical trials and human research
- Clinical trial registrations and disclosures
- Practical impact of organizations sponsoring, conducting or involved in clinical trials or human research
- What providers and counsel need to do to ensure compliance
- Informed consent
- Secondary research
The panel will review these and other key issues:
- How do the new regulations change the requirements for clinical trials? Human research?
- What will the practical impact be on organizations involved in clinical trials or human research?
- What must organizations sponsoring or conducting clinical research do now to ensure compliance with the new rules?
David Peloquin, Esq.
Ropes & Gray
Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the... | Read More
Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the area of clinical research and health data privacy. Prior to attending law school, he worked as a project manager for a leading supplier of electronic medical records. Mr. Peloquin is a frequent author and lecturer on clinical research/human subject protection issues, among others.Close
Thomas D. Shrack, Esq.
Hall Render Killian Heath & Lyman
Mr. Shrack focuses his practice on clinical services and patient care issues, corporate counsel services, medical staff... | Read More
Mr. Shrack focuses his practice on clinical services and patient care issues, corporate counsel services, medical staff relations, and regulatory and compliance and legal and ethical issues involved in clinical research activities. He also provided counsel on issues including, but not limited to, the development, registration and conduct of clinical investigations, government audits and investigations, the impact of fraud and abuse laws and FCA on research, FDA regulations, the Common Rule, pharmaceutical pricing and clinical trial billing compliance, medical device approval submissions, and various reporting obligations.Close
Other Formats— Anytime, Anywhere
CLE On-Demand Video