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
Foley & Lardner
Ms. Faget’s practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug... | Read More
Ms. Faget’s practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug & Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code, and the PhRMA Code. She has extensive experience drafting and negotiating agreements with and for contract/clinical research organizations and site management organizations. She regularly drafts and negotiates clinical trial agreements, informed consents, and other clinical development agreement on behalf of pharmaceutical and medical device clients. Ms. Faget also assists companies in structuring, developing, and implementing corporate compliance programs suitable for pre-commercial stage and commercial stage pharmaceutical and medical device companies, including drafting core compliance policies and advising on Sunshine Act reporting obligations. Prior to joining the firm, Ms. Faget held in-house positions at pre-commercial and commercial stage companies.
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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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