Ropes & Gray Attorneys Author Article on EMA’s Draft Policy Re: Clinical-Trial Data
Boston health care partner Mark Barnes
, Washington, D.C. life sciences counsel Kellie Combs
and Boston corporate associate David Peloquin
co-authored an article entitled “EMA Draft Policy on Publication and Access to Clinical Trials Data Provides Broad Researcher Access to Participant-Level Data” with Harvard Medical School professor Barbara Bierer. In the article—published on July 17 in Bloomberg BNA’s Medical Research Law & Policy Report
and is scheduled to republish in Bloomberg BNA’s Life Sciences Law & Industry Report
in August—the authors discuss unanswered questions raised by the European Medicines Agency’s (EMA) draft policy and the impact the EMA’s final policy will have once it takes effect, likely on January 1, 2014.
to read the article.