Pharmaceutical Law, Medical Devices Law, Clinical Research, Healthcare Compliance, Product Promotion Law, Contract Management, Due Diligence
Dr Heike Wachenhausen, born in 1968, studied law at the University of Göttingen. Her dissertation on ‘Medical experiments and clinical trials on people unable to give their consent’ won the Science Award bestowed by Gesellschaft für Recht und Politik im Gesundheitswesen (GRPG e. V.), a law and politics in healthcare organisation, in 1999. At the same time, she gathered valuable experience in the research and development of pharmaceuticals and medical devices providing judicial support to two ethics commissions (Göttingen and Hannover).
From 2000 to 2003 she worked as a lawyer in the industry working group ‘Healthcare, life sciences & chemicals’ at the international law firm Clifford Chance in Düsseldorf. She then moved to the law firm, Sträter Rechtsanwälte in Bonn, where she worked from 2003 to 2009. At both firms she specialised in advising companies operating in the fields of pharmaceuticals and medical devices and providing counsel for medical institutions and doctors.
In 2009, Dr Wachenhausen accepted an offer from Novartis Pharma AG to work from the company’s headquarters in Basel, Switzerland, as an in-house counsel. There, in the function of Head Legal Regulatory & Development, she built up a global team for the legal department, which devotes itself exclusively to cases involving regulatory issues.
In 2011, Dr Wachenhausen decided to return to Germany in order to set up her own law firm, which would specialise in pharmaceutical law and medical devices law and to use her many years of experience advising industrial companies as an in-house specialist or as an external legal adviser. Following her involvement as a partner in a regional law partnership based in Lübeck, she has further intensified her Lübeck-based activities since June 2013 as founder of the law firm Wachenhausen Rechtsanwälte.
Areas of expertise
- Pharmaceutical Law
- Medical Devices Law
- Clinical Research
- Healthcare Compliance
- Product Promotion Law
- Contract Management
- Due Diligence
Dr Wachenhausen is the author of various publications and a speaker at specialist conferences. She annotates, for example, Sections 40 ff. of the German Drug Act (AMG) on clinical trials of medicinal products on human beings in the AMG commentary (eds. Kügel/Müller/Hofmann) and is editor of the Wiesbaden commentary on medical devices law (eds. Hill/Schmitt). Since 2013 she has chaired the Forum für Medizintechnik e. V. and has appeared regularly as a speaker on various pharmaceutical law topics at the European Centre for Regulatory Affairs (EUCRAF) in Freiburg. She is also a joint publisher of the Medizinprodukte Journal (MPJ) magazine.
Dr Wachenhausen provides legal advice in German and English.