Insights

EMA Calls for Public Consultation on Clinical Trial Protocol, <i>Pharmaceutical & Medical Device Update</i>, Vol. IV, Issue III

EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014). The guideline is intended to provide advice on what is to be classified as a serious breach and sets out the types of incidents that should be reported. The consultation is open until August 22, 2017.

Jones Day publications should not be construed as legal advice on any specific facts or circumstances. The contents are intended for general information purposes only and may not be quoted or referred to in any other publication or proceeding without the prior written consent of the Firm, to be given or withheld at our discretion. To request reprint permission for any of our publications, please use our "Contact Us" form, which can be found on our web site at www.jonesday.com. The mailing of this publication is not intended to create, and receipt of it does not constitute, an attorney-client relationship. The views set forth herein are the personal views of the authors and do not necessarily reflect those of the Firm.

We use cookies to deliver our online services. Details of the cookies and other tracking technologies we use and instructions on how to disable them are set out in our Cookies Policy. By using this website you consent to our use of cookies.