认识和联系Profil的专家

Elke_Hexagon 

Elke Gurschke
高级法规事务经理

Elke在药物法规事务方向拥有硕士学位，她在Profil是临床试验相关所有法规事务领域的专家。 

  • 法规事务

简介

在营养学的专业学习后，Elke在两家制药公司担任医药代表数年。在2007年开始在Profil的工作之前，她还在网站Rheuma-Online.de担任科学作家，并在一家医疗机构担任质量管理者代表。2009年，她开始了药物监管事物的学习，并于2011年获得了相应的硕士学位（MDRA）。自加入Profil以来，她在临床试验监管的各个方面获得了广泛的知识，这让她成为了我们在此领域与您沟通的主要联系人。

 

主要成就及工作经验

2018 -

Senior Regulatory Affairs Manager, Profil GmbH, Neuss, Germany

2009 - 2018

Regulatory Affairs Manager, Profil GmbH, Neuss, Germany

2009 - 2011

Studies of Drug Regulatory Affairs, Rheinische Friedrich-Wilhelms-University, Bonn, Germany; final degree: Master of Drug Regulatory Affairs (MDRA)
Master’s Thesis: Best Practice Guide for Regulatory Affairs in a German CRO

2007 - 2009

Executive Administrator Clinical Science, Profil GmbH, Neuss, Germany

2007

Advanced training and certification as Quality Management Representative (LVQ/TÜV)

2005 - 2007

Executive Assistant & Quality Management Representative, Dr. Langer, Düsseldorf, Germany

2004 - 2006

Scientific Writer “Rheuma-Online”, Meerbusch, Germany

1988 - 1992

Pharmaceutical Representative, Wyeth Pharma GmbH, Münster, Germany

1985 - 1987

Pharmaceutical Representative, Smith Kline Dauelsberg GmbH, Munich, Germany

1984

Advanced training and certification as Pharmaceutical Representative

1979 - 1984

Studies of Nutritional Sciences, Justus-Liebig-University, Gießen, Germany; final degree: Nutritionist (Dipl. oec. troph.)