It remains the mission of all stakeholders to get high quality medicines to patients as time- and cost-efficiently as possible. To facilitate this process, the EMA has taken a number of initiatives to make clinical data, submitted to support marketing authorisations, increasingly available to industry and the general public alike.
However, it is important that the data made public is presented in such a way that it is not possible to identify specific individuals who participated in a clinical study and to ensure that their personal data is appropriately protected, in line with current legislation.
In this paper, you will see the latest data transparency updates for Policy 70 and the timelines for Clinical Reports.
Chris Wilson - Senior Director, Drugs and Biologics
Chris has two responsibilities within Voisin Consulting Life Sciences (VCLS). As Senior Director, he manages projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of small molecules and biologics; and as Head, Medical Writing, he provides leadership for this function.