The UK government recently unveiled its 10-year Life Sciences Sector Plan, putting forward a comprehensive strategy for transforming the UK into a global leader in life sciences by 2035. This LawFlash outlines key areas of...more
EU – REGULATORY -
Brexit, Notified Bodies, and Medical Devices -
The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
8/20/2019
/ Anti-Kickback Statute ,
Asia ,
China ,
Competition ,
Data Privacy ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
UK Brexit
With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more
10/12/2015
/ Binding Corporate Rules ,
Data Privacy ,
Data Protection Authority ,
Data Security ,
EU ,
EU Data Protection Laws ,
European Commission ,
European Court of Justice (ECJ) ,
Health Information Technologies ,
Informed Consent ,
International Data Transfers ,
Life Sciences ,
Medical Devices ,
Personal Data ,
Pharmaceutical Industry ,
PHI ,
Prior Express Consent ,
SCC ,
Schrems I & Schrems II ,
Third-Party ,
Umbrella Agreement ,
US-EU Safe Harbor Framework
The European Medicines Agency moves to increase EU clinical trial transparency.
The last five years have seen a sea change in the attitude of EU authorities regarding the disclosure of clinical trial results, moving from...more
8/5/2015
/ Clinical Trials ,
Confidential Information ,
Data Privacy ,
Data Protection ,
Data-Sharing ,
EU ,
Medical Research ,
New Regulations ,
Personally Identifiable Information ,
PHRMA ,
Transparency