Distance Learning

Clinical Trial Agreements: Beyond the Basics

Time: 2:00-3:30 PM Eastern (90 minutes)
Session Format: Live Webinar

This webinar will delve beyond the traditional sponsor-initiated multi-center clinical trial and examine the contractual terms that arise in alternative types of clinical trials.  The types of clinical trials this webinar will examine include investigator-initiated trials, compassionate use trials, trials that involve investigational products from more than one manufacturer, trials that involve a consortium, and trials involving telemedicine apps.

The speakers intend to discuss the operational and legal considerations that apply to these types of trials.  The presenters also will discuss recent developments within the FDA, including the changes spurred by the 21st Century Cures Act, and how those developments affect the negotiation of clinical trial agreements.  The panelists will present the perspective of both manufacturers and study sites when entering into agreements that govern these types of trials.  

Level of Difficulty: Intermediate

Intermediate-level programs generally offer focused discussions regarding common legal issues pertaining to the program topic. Intermediate programs include legal updates and changes in the law. Speakers will assume the audience has a working knowledge of this specialty of health law, and there will be limited review of the fundamentals. This program is designed to provide a targeted, comprehensive analysis of the subject matter for those practicing law in this specialty for three to seven years and/or those whose practice is periodically focused in the covered subject area. 

  • Member of Sponsoring Practice Group(s) (see "Sponsor(s)" tab for details): $99
  • Government, Academician, Public Interest, or Solo Practitioner AHLA Member: $75
  • Student, Paralegal, or Retired AHLA Member: $50
  • Other AHLA Member: $150
  • Non-AHLA Member: $325
  • AHLA Member Listen with a Colleague Option (see "Listen with a Colleague" tab for details): $75
  • AHLA Non-Member Listen with a Colleague Option (see "Listen with a Colleague" tab for details): $95

Sponsoring AHLA Group:

  • Academic Medical Centers and Teaching Hospitals Practice Group 

Co-sponsoring AHLA Groups:

  • Business Law and Governance
  • Hospitals and Health Systems
  • Regulation, Accreditation and Payment

Maureen Bennett

Partner

Jones Day
Boston, MA
Bio

Helene Orescan

Director, Clinical Trials Contracts & Strategic Relations

University of California Los Angeles
Los Angeles, CA
Bio

Priya Sankar, JD, MPH

Senior Director, Corporate Counsel

Incyte
Philadelphia, PA
Bio

Live Webinars

Live webinars are eligible for Continuing Legal Education (CLE) credit. Please refer to the Distance Learning CLE State Chart for details regarding specific state guidelines.

  • For attorneys licensed in states in which live distance learning programs are approved and AHLA possesses approved provider/sponsor status: AHLA webinars are pre-approved for CLE credit. Certificates of completion are made available immediately following the webinar upon completion of the course evaluation. Those states are: Indiana, Louisiana, New Jersey, New York, Pennsylvania, and Virginia.
  • For attorneys licensed in states in which live distance learning programs are approved and AHLA does not possess approved provider/sponsor status: participants are able to apply directly to their state accrediting body for approval for and accreditation of AHLA-sponsored webinars. The application and agenda are available for download during the live event and any time thereafter; certificates of completion are made available immediately following the webinar upon completion of the course evaluation.
  • In states in which live distance learning programs are not approved, it is still possible to obtain CLE credit by applying directly to the state's accrediting body for “self-study" credit where applicable.

Other, Non-CLE Credits

AHLA webinars are only presumptively approved for CLE credits unless otherwise stated. To obtain other credit types (Continuing Professional Education, Compliance Certification Board, Nursing Home Administrator, etc.) participants may apply directly their desired licensing body, but approval is not guaranteed and is at the discretion of said licensing body and subject to its rules and regulations.

For additional information about Distance Learning-related credits, please email the Practice Groups staff at dl@healthlawyers.org.

Prior to a live event, you may test your web browser to be sure you have the required Flash software. To do so, direct your web browser to the following URL: www.ec.commpartners.com. Click on the "Browser Test." If you pass the test, you will see a Congratulations message. If you do not, you will be given instructions on where you can download the newest version of Flash. This is a free download.

It is recommended that you use a high speed/broadband internet connect (Wifi is not recommended), a PC with Windows and Internet Explorer 9.0 or higher. If you are using a Mac, please use the Safari web browser.

The “Listen with a Colleague" option allows multiple registrants from the same organization and location to participate in the webinar at a discounted rate. It may ONLY be used if at least one person from your organization and location has registered at the regular/full webinar registration rate. Please note that those who register under the reduced “Listen with a Colleague" rate must access the webinar from the same location and computer as the full-priced registrant they are registered under.

The “Listen with a Colleague" option is continuing legal education (CLE) credit-eligible. In order to obtain a certificate of completion for submission to a state CLE accrediting body, those registered under this option must obtain the attendance verification code—which will be displayed at a random time during the webinar—and enter that code under “Verification Code for Live Webinar" section of the webinar description webpage. Please note that each registrant must submit a complete evaluation from their individual accounts to obtain a certificate of completion.

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If you have any questions about this registration option, please contact customer support.

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