Clinical Trials and Human Research: Complying With Regulatory Obligations

Requirements for Informed Consent, Disclosures, Data-Sharing and More

A live 90-minute CLE webinar with interactive Q&A


Thursday, July 18, 2019

1:00pm-2:30pm EDT, 10:00am-11:30am PDT

or call 1-800-926-7926

This CLE webinar will guide counsel on navigating regulatory changes for clinical trials and human subjects research. The panel will examine the practical impact for those sponsoring, conducting or otherwise involved with clinical trials and will outline compliance strategies to meet the new requirements.

Description

In the past few years, Congress and federal departments and agencies have issued several statutory and regulatory changes that impact the conduct of human subjects research. Developments include the passage of the 21st Century Cures Act and the issuance of the final rule revising the Common Rule and related guidance issued thereunder.

Further, the EU’s General Data Protection Regulation (GDPR) introduces new requirements related to collection and sharing of personal data, including personal data collected in the context of a clinical trial, and can introduce difficulties, particularly where the obligations may vary across jurisdictions. Attorneys advising organizations sponsoring, conducting or involved with clinical trials and human research must fully understand the scope and complexity of legal developments as well as the implications of the GDPR to ensure clients are in full compliance.

Listen as our authoritative panel examines the changes in the regulatory environment for clinical trials and human research. The panel will provide guidance on the new requirements and discuss the impact on organizations sponsoring or conducting clinical trials and human research. The panel will offer best practices for meeting the changing standards.

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Outline

  1. Regulatory landscape for clinical trials and human research
  2. GDPR compliance
  3. The practical impact of organizations sponsoring, conducting or involved in clinical trials or human research
  4. What providers and counsel need to do to ensure compliance
    1. Informed consent
    2. Disclosures
    3. Data-sharing
    4. Secondary research
    5. Others

Benefits

The panel will review these and other key issues:

  • How do recent regulations change the requirements for clinical trials or other human subjects research?
  • What will the practical impact be on organizations involved in clinical trials or other human subjects research?
  • What must organizations sponsoring or conducting clinical research do now to ensure compliance with the rules?

Faculty

DiMaio, Michael
Michael DiMaio

Atty
Ropes & Gray

Mr. DiMaio advises healthcare providers, pharmaceutical and medical device manufacturers, and other healthcare...  |  Read More

Peloquin, David
David Peloquin, J.D.

Atty
Ropes & Gray

Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the...  |  Read More

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Strafford will process CLE credit for one person on each recording. All formats include program handouts. To find out which recorded format will provide the best CLE option, select your state:

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DVD

10 business days after event

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