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


Conducted on Thursday, March 14, 2019

Recorded event now available

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Program Materials

This CLE webinar 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.

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.

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Outline

  1. FDA guidance
  2. Common Rule changes
  3. Impact on the regulatory landscape
  4. 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

Faget, Kyle
Kyle Y. Faget

Special Counsel
Foley & Lardner

Ms. Faget’s practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug...  |  Read More

George, LaDale
LaDale K. George

Partner
Perkins Coie

Mr. George is a highly experienced legal advisor and strategic counselor on regulatory compliance and business...  |  Read More

Schmitt, Nora
Nora Lawrence Schmitt

Atty
Moses & Singer

Ms. Schmitt advises academic medical centers, pharmaceutical companies, hospitals, and physician organizations on the...  |  Read More

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