Prof. Dr. Heike Wachenhausen

Rechtsanwältin, Partner
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Prof. Dr. Heike Wachenhausen

Prof. Dr. Heike Wachenhausen started her own practice in Lübeck in 2011 and is the founding Partner of Wachenhausen Rechtsanwälte, which was established in 2013. She focuses her practice on regulatory matters related to the development, manufacture, transport and distribution of medicinal products and medical devices. Prior to that, she worked as Head Legal in the Legal Department of Novartis Pharma AG in Basel, where she was responsible for the division Regulatory & Development. Prior to her in-house experience, she worked as a lawyer at Sträter Rechtsanwälte in Bonn (2003 to 2009) and at Clifford Chance in Düsseldorf (2000 to 2003). In both law firms, she advised pharmaceutical and medical devices companies as well as medical institutions and doctors. Prof. Dr. Wachenhausen studied at the Georg-August-University of Göttingen, where she also worked at the Chair of Professor Dr. mult. Erwin Deutsch for several years. She has been the author of a number of relevant publications and is an experienced speaker at professional events and in-house trainings. Among other things, she is a co-author of the chapter on clinical trials with medicinal products in the publication Medizinprodukterecht by Anhalt / Dieners, an editor of the legal commentary WiKo – Medizinprodukterecht by Hill / Schmitt and the co-publisher of the Medizinproduktejournal (MPJ). In addition, she annotates Sections 40 et seqq. of the German Medicinal Products Act concerning clinical trials of medicinal products involving human subjects in the legal commentary Arzneimittelgesetz by Kügel / Müller / Hofmann. Moreover, she is a member of the Committee “Clinical Research” of the German Federal Association of the Pharmaceutical Industry (BPI). Since December 2017 she is honorary professor at the Department of Applied Natural Sciences at the Technische Hochschule Lübeck. Dr. Wachenhausen provides legal advice in German and in English.


Prof. Dr. Wachenhausen focuses on:



Bundesverband der Pharmazeutischen Industrie e.V. (BPI) Kanzleimitgliedschaft Wachenhausen Rechtsanwälte Persönliches Mitglied des Ausschusses Klinische Forschung des BPI 1. Vorsitzende des Forum für Medizintechnik e.V. (FFM) Korrespondierendes Mitglied im Arbeitskreis Recht des Bundesverband Medizintechnologie e.V. Persönliches Mitglied bei der Deutschen Gesellschaft für Pharmazeutische Medizin (DGPharMed) INTEGRITAS Verein für lautere Heilmittelwerbung e.V. Kanzleimitgliedschaft Wachenhausen Rechtsanwälte Life Science Nord e.V. Kanzleimitgliedschaft Wachenhausen Rechtsanwälte Förderkreis der Forschungsstelle für Pharmarecht an der Philipps-Universität Marburg e.V. Kanzleimitgliedschaft Wachenhausen Rechtsanwälte


Der Bevollmächtigte des Herstellers nach Art. 11 MDR – Benennung, Aufgaben und Haftungsumfang

Prof. Dr. Heike Wachenhausen
zusammen mit Luka Weinert
MPJ 2/2019, S. 97 ff.

Nichtinterventionalle Studien in Deutschland – NIS

Prof. Dr. Heike Wachenhausen
in Hinze/Gleiter/Herbold (Hrsg.)
zusammen mit Cornelia Schiemann, LL.M.
Pharmind Serie Dokumentation, 1. Auflage 2018
ECV Editio Cantor Verlag

Datentransparenz versus Datenschutz bei klinischen Prüfungen

Prof. Dr. Heike Wachenhausen
A&R 2016, S. 147 ff.