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AHLA Life Sciences Law Institute Program

Datum: 14-16 October 2009
Ort: Renaissance Washington DC Hotel; 999 Ninth Street NW; Washington, D.C. 20001

Squire, Sanders & Dempsey L.L.P. partner Maureen Bennett will co-present “Conducting Clinical Trials in the US and Abroad: Navigating the Rising Tide of Regulation and Risk” at the American Health Lawyers Association (AHLA) Life Sciences Law Institute program with Jan Murray, deputy general counsel with the Cleveland Clinic. Ms. Bennett and Ms. Murray will present the session twice on October 15, 2009, at 10:45-11:45 a.m. and 2:45-3:45 p.m.

The workshop will cover:

  • The legal framework for conducting clinical trials in the United States and around the world; increasing federal scrutiny of global clinical trials; developing Good Clinical Practice (GCP) guidelines; the impact of local law on the conduct of clinical trials
  • Special considerations in conducting clinical trials in developing regions of the globe; strategies for securing ethical review and special informed consent issues; risk/liability issues and risk minimization strategies in countries with unstable regimes
  • Industry and academic medical center (both US and non-US) relationships; continuing contracting controversies and initiatives to craft widely accepted templates in the United States and other countries; ethical and legal issues in supporting investigator-initiated trials around the world; emerging disclosure and conflict of interest issues in industry/investigator relationships.
  • Outsourcing sponsor responsibilities and the evolving roles of academic research organizations (AROs), clinical research organizations (CROs) and site management organizations (SMOs); due diligence in the use of AROs, CROs and SMOs and management of the relationship

 

The AHLA Life Sciences program, taking place October 14-16, is an educational conference focusing on the intersection of health law and life sciences. The program will include a practical agenda for life science and health care lawyers. Dr. Joshua M. Sharfstein, principal deputy commissioner of the FDA, will give the keynote address. Breakout sessions will cover significant legal issues on:

  • Pharmaceutical and device company relationships with physicians
  • Structuring outsourcing transactions
  • How privacy and security laws apply to life science companies
  • Biosimilars
  • Updates on FDA regulatory requirements
  • Government investigations

 

Attendees who would like to schedule time to meet with Ms. Bennett at the conference are encouraged to contact John Nisky at +1.216.479.8531.

Squire Sanders has the legal, business and industry experience to help life sciences companies meet the challenges confronting the industry and maximize their business opportunities. Our lawyers have an in-depth understanding of the industry, gained through their representation of clients in life sciences and interrelated sectors such as health care, biotechnology, pharmaceuticals and medical devices.

See the event website to register.

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+1.216.479.8531