Prof. Dr. Heike Wachenhausen
Prof. Dr. Heike Wachenhausen has been working with Susanna Dienemann in her own law firm since 2012 and founded Wachenhausen Rechtsanwälte in 2013. After many years of partnership with Susanna Dienemann, the firm was renamed in Wachenhausen Dienemann Rechtsanwälte in 2023. Mrs. Wachenhausen 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).
Furthermore, Prof. Dr. Heike Wachenhausen has been an honorary professor in the Department of Applied Natural Sciences at the Technische Hochschule Lübeck since 2017. She has been involved in Life Science Nord e.V. as its first chairperson since September 2021 and is a member of the board of trustees of Fraunhofer IMTE.
Prof. Dr. Wachenhausen provides legal advice in German and in English.
Prof. Dr. Wachenhausen focuses on:
Bundesverband der Pharmazeutischen Industrie e.V. (BPI)
Kanzleimitgliedschaft Wachenhausen Dienemann Rechtsanwälte
Persönliches Mitglied des Ausschusses Klinische Forschung des BPI
Persönliches Mitglied des Forums 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 Dienemann Rechtsanwälte
Life Science Nord e.V.
Kanzleimitgliedschaft Wachenhausen Dienemann Rechtsanwälte
Förderkreis der Forschungsstelle für Pharmarecht an der Philipps-Universität Marburg e.V.
Kanzleimitgliedschaft Wachenhausen Dienemann Rechtsanwälte
Lectures
Medizinprodukteberater MPB
Online-Seminar
26. und 27. November 2024
BVMed-Akademie
Zertifikatslehrgang Praxiswissen Recht-Verantwortliche Person nach Art. 15 EU-MDR-zwischen Verantwortung u. Haftung
Online-Seminar
05. Dezember 2024
Medical Mountains
Publications
Qualitätssicherung in der Lieferkette – Die Qualitätsvereinbarung auf dem Prüfstand
Prof. Dr. Heike Wachenhausen
MPJ 3/2021, S. 188 ff.
Outsourcing von klinischen Prüfungen – Vertragsgestaltung und Datenschutz
Prof. Dr. Heike Wachenhausen
Pharm.Ind. 81, Nr. 12, 1664-1675 (2019)
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.