Starting with 2016, we are representing a reputable French pharmaceutical laboratory in some files / procedures that overlook the way in which clinical trials are being carried out in Romania. These studies impact both the local and the European medical community. For this reason, the courts in Romania, where our client operates these studies, want to ensure that the optimal conditions are met for the conduct of the respective studies. Conditions that materialize in respecting good practice in conducting Phase II clinical trials (our case). Phase II clinical trials set out the following: efficacy of the drug tested, efficacy in disease prevention, and appropriate dosage levels.
To start a clinical trial in Romania you need the approval from two national forums: the National Medicines Agency and the National Ethics Commission. Once these approvals have been obtained under the current legislation, the clinical trial may begin. The legislation is comprised on a set of regulations called “Good Clinical Practice.”
We are still in the process of carrying out these procedures, which we expect to be finalized sometime during this year/2019. Throughout this period, we provided consultancy services that consisted of monitoring the initial file and analyzing the papers and requests coming from the parties involved. We also proposed to the client the strategy and recommendations we considered appropriate to combat the actions filed against its rights and interests.