ACI's 3rd Legal and Regulatory Forum on Conducting International Clinical Trials Boston
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date(s):
September 25, 2008
- September 26, 2008 -
location:
Boston
related attorney(s):
On Thursday, September 25 at 3pm, Morgan Lewis's Anthony Warnock-Smith will present "Spotlight on the EU: Documenting Compliance with Evolving Guidance When Designing Multi-Center/Country Studies and Examining Implementation Issues in Key Member States."
With clinical trials undertaken by U.S. pharmaceutical and biotech companies increasingly being designed as international in scope, it is critical for sponsors to overcome the key legal and regulatory obstacles inherent in conducting such trials. The international variability in legal frameworks for recruiting, reimbursements, data privacy, and human subject protection has made drafting international CTAs and negotiating informed consent documents a constant struggle. And with indemnity requirements, IP protections, and publication rights varying by country and region, boilerplate contractual provisions must be carefully adapted to reflect specific concerns relating to the sites being utilized.
When:
September 25-26, 2008
Where:
Radisson Hotel
Boston, MA