Description
In Oct. 2018, the FDA issued new guidance on complying with agency regulations and Common Rule revisions that govern research involving human subjects in clinical trials. It focuses on informed consent, expedited review procedures and IRB continuing review. The FDA published the Final Rule to revise the Common Rule in 2017, and many of the provisions went into effect in 2018.
The Common Rule has been in place since 1991, and the revisions provide a regulatory update in light of the many changes in the healthcare and life sciences industries since that time. The Final Rule addresses issues concerning informed consent, secondary research use of information and biospecimens, harmonization with the HIPAA Privacy Rule, review of multi-site research, and more.
Attorneys advising stakeholders in healthcare and the life sciences, including drug and device manufacturers, hospitals, academic medical centers, universities and medical schools, and institutional review boards, must fully understand the scope and complexity of the Common Rule revisions as well as the recent FDA guidance to ensure clients are in full compliance.
Listen as our authoritative panel examines the agency regulations and the Common Rule revisions for clinical trials and human research. The panel will discuss the new FDA guidance and consider the impact on stakeholders involved in clinical trials and human research. The panel will outline compliance strategies to meet the regulatory requirements.
Presented By
Ms. Faget advises investors, academic medical centers, physician practices, and consultants on a range of business, legal and regulatory issues affecting the telemedicine industry. She helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code. She regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products, including licensing agreements, collaboration agreements, clinical trial agreements, and an array services agreements.
Mr. George is a highly experienced legal advisor and strategic counselor on regulatory compliance and business transactions. He concentrates his regulatory compliance practice on advising healthcare clients and his transactional counsel on healthcare and non-healthcare corporate matters. He guides clients engaged in traditional and innovative healthcare businesses through complicated regulatory frameworks, including FDA, OHRP, NIH, and ORI regulated clinical research, clinical development, and post-approval marketing compliance; telehealth/telemedicine and multi-state provider licensing compliance; Stark Law and Anti-Kickback Statute compliance; FTC and CMS regulated clinical integration, and federal research grant management compliance.
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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Date + Time
- event
Thursday, March 14, 2019
- schedule
1:00 PM E.T.
- FDA guidance
- Common Rule changes
- Impact on the regulatory landscape
- What providers and counsel need to do to ensure compliance
The panel will review these and other key issues:
- How do the recent FDA guidance and the Common Rule revisions change the requirements for human subjects research, including clinical trials?
- What will the practical impact be on organizations involved in clinical trials or human research?
- What steps must healthcare industry stakeholders take to ensure compliance?
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