Clinical Trials and Human Research Compliance: New FDA Guidance and Revised Common Rule
Complying With Agency Regulations for Informed Consent, Expedited Review and IRB Continuing Review
Recording of a 90-minute CLE webinar with Q&A
This CLE course will guide counsel for navigating agency regulations and the Common Rule revisions for clinical trials and human subjects research. The panel will discuss the new Food and Drug Administration (FDA) guidance, examine the practical impact for stakeholders such as hospitals, research organizations and drug manufacturers, and will outline compliance strategies to meet the regulatory requirements.
Outline
- FDA guidance
- Common Rule changes
- Impact on the regulatory landscape
- What providers and counsel need to do to ensure compliance
Benefits
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?
Faculty
Kyle Y. Faget
Partner, Co-Chair Health Care Practice Group, Co-Chair Health Care & Life Sciences Sector’s Medical Device and Equipment Area of Focus
Foley & Lardner
Ms. Faget advises investors, academic medical centers, physician practices, and consultants on a range of business,... | Read More
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.
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LaDale K. George
Partner
Perkins Coie
Mr. George is a highly experienced legal advisor and strategic counselor on regulatory compliance and business... | Read More
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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Nora Lawrence Schmitt
Attorney
Moses & Singer
Ms. Schmitt advises academic medical centers, pharmaceutical companies, hospitals, and physician organizations on the... | Read More
Ms. Schmitt advises academic medical centers, pharmaceutical companies, hospitals, and physician organizations on the conduct and oversight of clinical research, including human subject protection and the privacy of research subjects’ information. She counsels academic medical centers and other research organizations on research affiliations and contracting matters and regularly assists healthcare providers and pharmaceutical companies on matters related to HIPAA, HITECH, and state privacy laws. Ms. Schmitt supports healthcare providers in the field of managed care contracting, including in the formation and maintenance of ACOs, physician hospital organizations, and independent practice associations. She also provides counsel regarding fraud and abuse laws, including the Stark Laws and the Anti-Kickback Statute.
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