Lene Grejs Petersen is Senior Adviser at the Danish Medicines Agency, Clinical Trial Unit. Lene has been member of the Clinical Trials Facilitation Group (CTFG) member since 2008 and the Danish representative of the EU Commission’s expert group concerning clinical trials since 2001. Lene has been an employee at the Danish Medicines Agency since 2000 and she is involved in the implementation of the EU Clinical Trials Regulation into Danish legislation and works as a regulatory assessor and coordinator of clinical trial applications including VHP. Lene has a background as Master in Pharmacy.