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ACI: International Clinical Trials
from Miscellaneous Group
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Thursday, September 25, 2008 8:00am - Friday, September 26, 2008 3:30pm
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.
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