Event

Clinical Trial Data Transparency: An EU & US Perspective

May 18, 2016
05:00 PM - 06:00 PM GMT
12:00 PM - 01:00 PM ET
09:00 AM - 10:00 AM PT

The last five years have seen a sea change in the attitude of EU authorities regarding the disclosure of clinical trial results. Such attitudes have moved from a presumption of confidentiality to an expectation to disclose all but the most obviously commercially confidential information (CCI) and subject personal data.

As the European Union prepares for the new regulation introducing a publicly accessible clinical trial database, it is useful to look at how the EU and US regulatory requirements may affect strategic considerations for conducting clinical trials in each region.

Please join our Washington, DC, and London lawyers for a one-hour webinar to discuss the implications for product development across the EU and US markets.

TOPICS WILL INCLUDE:

  • EU general reactive disclosure rules
  • The European Medicines Agency’s proactive disclosure policy
  • Trial disclosures under the new EU Clinical Trials Regulation
  • The US approach to CCI and comparable US/National Institutes of Health requirements and US industry practices
  • Strategic consequences for the conduct of international research programs

CLE credit: CLE credit in CA, FL, IL, NJ (via reciprocity), NY, PA, TX, and VA is currently pending approval.