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Eda Zhuleku

Counsel

Email

eda.zhuleku@aoshearman.com

Phone

+49 89 71043 3125

Offices

Munich

V-CARD
Eda advises national and international companies on all kind of regulatory aspects in the Life Sciences sector. 
Eda is an expert with respect to all regulatory issues that may be of interest to pharma, medical device, IVDs and life science businesses, including market access strategies, prescription of drugs and medical devices and eligibility for reimbursement. Further, she assists in every stage of the product life-cycle and advises pharma businesses, medical device and other life sciences businesses on challenges in terms of reimbursement and social law. She is a regular commentatrice on new LS regulatory developments. 

Expertise

Industries

Experience

Representative matters

  • A global pharmaceutical and healthcare company in connection with the coordination and strategic advice on the defence and enforcement of intellectual property rights relating to its best-selling drug, Xarelto, throughout Europe. 
  • KühneHolding AG and E3X Partners GmbH in connection with the planned acquisition of the pharmaceutical contract developer and manufacturer AenovaGroup from the private investment company BC Partners. 
  • Carl Zeiss Meditec in connection with a cloud-based digital health platform as well as the implementation of this health platform in an app. 
  • Organon on comprehensive regulatory questions on medicinal products and medical devices as well as on corresponding distribution channels, import, pharmacovigilance, and advertising. 
  • Kyowa Kirin International (KKI) on its joint venture collaboration with global science-based, privately owned pharmaceutical company Grünenthal for KKI’s established medicines portfolio. 
  • Global pharmaceutical companies in patent litigation cases and related pharmaceutical law and regulatory questions.
  • A global pharmaceutical company on issues relating to the regulation of in vitro diagnostics, in particular the placement on the market of Laboratory Developed Tests (LDTs). 
  • Vision Healthcare, a consumer healthcare company headquartered in Belgium with an extensive portfolio of self-care brands and over-the-counter products in several European countries, on the acquisition of 100% of the shares of AixSwiss BV, a leading provider of probiotic dietary supplements. 
  • Enovis Corporation on investments in the German digital health market.

Pro bono

  • Eda is a member of the Pro Bono Steering Committee in Germany.
  • Supporting an international NGO in relation to applications of vulnerable Afghan citizens under the German Federal Admission Programme for Afghanistan (Bundesaufnahmeprogramm für Afghanistan).

Published Work

  • Zhuleku, E., Günther, S., Preinfalk, F. (2023), “Medical Devices: Sources of Regulation (Germany)”, Practical Law, Thomson Reuters
  • Zhuleku E. (2020) “Covid-19 and the Life Science Sector „Covid-19 and the Life Science Sector”, Practical Law ? London, Thomson Reuters
  • Zhuleku E. (2020) The German Healthcare system and digitalisation”, International Journal of Law and Technology
  • Zhuleku E, Professor Ehlers A, (2018) „Neues Bundesdatenschutzgesetz und EU?Datenschutzverordnung Anpassungsbedarf bei den Unternehmen“ in pharmind Nr. 1, 82 , Edition Cantor Verlag
  • Zhuleku E, Professor Ehlers A, (2016) „Die FSA?Kodizes und ihre Durchsetzung – wie konsequent ist das“ in: pharmind Nr. 6, 869, Edition Cantor Verlag
  • Zhuleku E, (2014) Die ärztliche Aufklärungspflicht nach dem Patientenrechtegesetz“ in: Der Diabetologe, Springer Medizin
  • Zhuleku E, (2013) „Rechtliche Stolpersteine des Bestandsmarktaufrufs“ in Highlights Magazin Ausgabe 8/13, Lehr & Visarius Verlag GmbH

Speaking Engagements

  • Panelist at AI in Pharma hosted by AI Hub during the AI Week in Frankfurt 2023
  • Guest Speaker at Medica-Tradefair 2023: How to navigate the regulatory landscape for companion diagnostics and AI-based medical devices used in clinical trials?
  • Lecturer, Drug Regulatory Affairs – Basic Course at the University of Augsburg
  • Lecturer, Health Care Management at the European Business School (EBS) 
     

Recognition

“Healthcare Rising Star of the Year”
Legal 500, 2024

Qualifications

Admissions

Certified Lawyer for Life Sciences since 2018
Disclaimer
A&O Shearman was formed on May 1, 2024 by the combination of Shearman & Sterling LLP and Allen & Overy LLP and their respective affiliates (the legacy firms). Any matters referred to above may include matters undertaken by one or more of the legacy firms rather than A&O Shearman.