Clinical Trial Agreements: Beyond the Basics - On Demand Recording
Recorded On: 03/19/2018
Time: 90 minutes
Session Format: On Demand Recording
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.
- AHLA Member: $145
- Non-AHLA Member: $275
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
On-Demand+CLE webinars are eligible for Continuing Legal Education (CLE) credit and are approved in every state with mandatory CLE requirements for attorneys unless otherwise specified. Please refer to the Distance Learning CLE State Chart for details regarding specific state guidelines.
Offerings designated as “On-Demand" differ from those designated as “On-Demand+CLE" in that they are CLE-ineligible. However, CLE credit may be obtained by applying directly to the attorney's state accrediting body, but approval is not guaranteed and is at the discretion of said accrediting body and subject to its rules and regulations. Please refer to the Distance Learning CLE State for details regarding specific state guidelines.
Other, Non-CLE Credits
AHLA On-Demand+CLE webinars are only 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 firstname.lastname@example.org.
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