Heike provides advice across the full range of regulatory matters relating to medicinal products and medical devices on German and European level with particular focus on development, marketing authorization and product safety (vigilance).
Heike has been working as a regulatory lawyer for fourteen years. She started her career in the practice group “Healthcare, Life Sciences and Chemicals” in the Düsseldorf office of Clifford Chance and for six years she worked with law firm Sträter in Bonn before she became Head Legal Regulatory & Development in the legal department of Novartis AG based in Basel, Switzerland, in 2009. In 2011, Dr Wachenhausen decided to return to Germany in order to set up her own law firm, which would specialize 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.
Heike holds a PhD in law. Her doctoral thesis deals with clinical trials with persons incapable of giving informed con sent.
Heike 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).
Languages: German, English