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The Life Sciences Practice Group provides educational and informational services and resources to in-house attorneys; outside counsel; government attorneys; compliance officers; finance and reimbursement executives, Food and Drug Administration, research, clinical trials and regulatory affairs professionals; and consultants who practice in the traditional life sciences field with respect to issues involving pharmaceutical manufacturers, medical device manufacturers, biotechnology companies, research and site management organizations, manufacturing and supplier vendors, prescription drug plans, wholesale distributors, retail and specialty pharmacies, pharmacy benefit managers, and the financial services firms that invest in these entities. This Practice Group concentrates on issues such as food and drug law regulation, third-party payment and reimbursement (e.g., coverage, coding and payment methodologies for products), fraud and abuse, government contracts, products liability, intellectual property, clinical trials, and research.
 

Benefits and Activities

 
Summaries of the Office of Inspector General (OIG) Advisory Opinions are provided by the Advisory Opinions Task Force of the Fraud and Abuse Practice Group. The Task Force aids Practice Group members in keeping abreast of new Advisory Opinions. For each new opinion issued by the OIG, a summary is released via an email alert and posted on several Practice Groups' websites.

​OIG Advisory Opinions

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You may access this content by joining AHLA and enrolling in Life Sciences Practice Group.


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​Member Briefings, prepared by members of Practice Groups, are a useful practice tool to facilitate your understanding of the most recent health law issues and to assist you and your clients with implementing those issues.

You may access this content by joining AHLA and enrolling in Life Sciences Practice Group.


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You may access this content by enrolling in Life Sciences Practice Group.

You may access this content by Renewing your membership for Life Sciences

​Executive Summaries, prepared by members of Practice Groups, are a useful practice tool to facilitate your understanding of the most recent health law issues as they develop.

You may access this content by joining AHLA and enrolling in Life Sciences Practice Group.


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You may access this content by enrolling in Life Sciences Practice Group.

You may access this content by Renewing your membership for Life Sciences

The Life Sciences Practice Group does not currently publish this type of content. Please review the other categories under this and other tabs to access content from this Practice Group.

Clinical Trial Agreements Tooolkit
— Published on March 10, 2016
The Clinical Trial Agreements (CTA) Toolkit is designed to assist health lawyers with understanding and negotiating clinical trial agreements between industry sponsors and academic medical centers in instances where the industry party is the sponsor of a study involving an investigational drug. The CTA Toolkit is divided into 17 sections that represent key provisions of a CTA and is designed to provide the ideal provisions from both the industry-sponsor and academic medical center-clinical trial site perspective, as well as the reasoning behind those positions. The Toolkit also provides an overview of the business importance of each of these sections; relevant federal, state, or local laws; case law; international laws; other directives and resources; and operational considerations.

— Published on May 4, 2010

Emergency Preparedness Toolkit
— Published on May 4, 2010

When an emergency hits a hospital, administrators often turn to their lawyers as issues arise in providing care during an emergency. This Emergency Preparedness Toolkit (Toolkit) is designed as a complement to AHLA’s Emergency Preparedness Response & Recovery Checklist: Beyond the Emergency Management Plan by providing a one-stop resource of emergency preparedness form policies, procedures, links, articles, sample contract language, and legal summary memoranda to assist healthcare attorneys, administrators, and providers in preparing for and responding to the issues that arise during an emergency.​

Upcoming:

Past:

The Consolidation Continuum: Alternative Provider Alignment Structures (Intermediate)
Part III: Bundled Payments and Post-Acute Care Networks-Hospital Affiliations with Long Term Care Providers (Intermediate)
April 8, 2016 2:00 PM-3:30 PM Eastern
The Consolidation Continuum: Alternative Provider Alignment Structures (Intermediate)
Part II: Hospital Partnership and Affiliation Models--A Strategic Framework (Intermediate)
March 23, 2016 2:00 PM-3:30 PM Eastern

Upcoming:

Past:

MONDAY, FEBRUARY 10, 2014

Upcoming:

Past:

February 9, 2016 12:00 PM-1:15 PM Eastern
July 1, 2015 12:30 PM-1:45 PM Eastern
June 29, 2015 12:30 PM-1:45 PM Eastern
April 16, 2015 12:00 PM-1:15 PM Eastern
March 26, 2015 12:15 PM-1:35 PM Eastern

​Affinity Groups

Affinity Groups are created to facilitate networking and educational opportunities with other Practice Group members who share similar professional interests.
Please note: You must be a member of Life Science Practice Group or a government, academician, student, or PG 15 member (all-Practice Groups access) to enroll in thes Affinity Groups. 

Task Forces

Task Forces are established for those health law topics that cross over several Practice Groups, and they provide collaborative, substantive resources for the benefit of the sponsoring Practice Groups' members.
Please note: You must be a member of the Life Sciences Practice Group or one of the other sponsoring Practice Groups to receive benefits produced by these Task Forces.
  • Accountable Care Organization Task Force
    The Accountable Care Organization (ACO) Task Force monitors and evaluates the implementing statutes, regulations, cases, and secondary materials concerning ACOs. It provides written materials, webinars, and in-person educational activities to assist AHLA's members to implement ACOs and comply with ACO laws and rules. Since the ACO subject matter is so broad, and impacts the missions and interests of so many Practice Groups, the ACO Task Force is a multi-disciplinary/multi-group entity, and focuses its efforts on the production of a coherent and effective line of ACO-related educational materials using a variety of media and employing AHLA’s vast resources
  • Health Care Reform Educational Task Force
    The Health Care Reform Educational Task Force serves as a single key point-of-contact for the Association membership for institutional resources regarding comprehensive health care reform initiatives at the state and federal levels. The Task Force works to educate AHLA members on proposed health care reform initiatives as well as report on ongoing experiences with recently enacted reform initiatives.

  • Webinars

    Roundtable Discussions


    LeadershipView Project Reports

    Image of KristianWerling
    Kristian Andrew Werling Chair McDermott Will & Emery LLP Chicago, IL (312) 984-2157 Email
    Image of StefanieDoebler
    Stefanie A. Doebler Vice Chair - Publications Covington & Burling LLP Washington, DC (202) 662-5271 Email
    Image of RyanJohnson
    Ryan S. Johnson Vice Chair - Membership Fredrikson & Byron PA Minneapolis, MN (612) 492-7160 Email
    Image of MaryamKhotani
    Maryam Khotani Vice Chair - Educational Programs Sunnyvale, CA (669) 224-1122 Email
    Image of AndyLemons
    Andy Lemons Vice Chair - Research & Website Hester & Lemons LLC Atlanta, GA 678-538-6427 Email
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    Heather M. Zimmerman Vice Chair - Strategic Planning and Special Projects Walgreens Co Deerfield, IL (847) 315-5405 Email

     

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