Legal Aspects in Life Sciences 4

Data Protection in International Research Cooperations 

Research in the life sciences sector takes place in most cases across national borders. Personal data is being shared from the setup of a research project to the final solution, therapy or product. Especially after the latest rulings at the European Court of Justice in 2020 (Schrems II) the transfer of this data is an enormous challenge. Whether the Standard Contractual Clauses (STC) of 2021 will be able to solve the data protection issues after the EU-US Privacy Shield has been invalidated is to be discussed. 
 

Focus

Legal Aspects of International Research and Development with Genomic Data
Thomas Szucs
  • Genetic data in the life sciences
  • Research meets Law – rules and regulations of genetic data
  • Development and challenges for researchers, patients and companies 
 
Legal Challenges of Cross-Border Data Transfers in International Research Cooperation after Schrems II 
Claudia Seitz
  • Impact and Legal Challenges of Cross-Border Data Transfers after the ECJ´s Schrems II Judgment
  • Navigating Cross-Border Data Transfers in the Pharmaceutical Sector after the Invalidation of the EU-US Privacy Shield Framework 
  • Legal Analsys of Standard Contractual Clauses (SCCs)
 
Cross-Border Data Transfers after Schrems II – Practical Steps for Organizations
Elvira Valverde Garcia
  • Analysis and reactions of the Schrems II judgment in the pharmaceutical sector
  • Practical steps for organizations to comply with Schrems II judgment
  • Practical examples and recommendations on how these challenges could be addressed 
 

Speakers

Thomas Szucs
Prof. Dr. med, Dr. iur., MD, MBA, MPH, LLM, JSD
Direktor des European Center of Pharmaceutical Medicine der Universität Basel

Thomas D. Szucs is Professor of Pharmaceutical Medicine and Director of the European center of Pharmaceutical Medicine at the University of Basel. He is also Professor of Medical Economics at the University of Zurich and Honorary Professor at the Peking University Health Science Center.  Previously, he was Chief Medical Officer of Hirslanden Holding, the largest private hospital chain in Switzerland. He worked academically at the Universities of Zurich, Milan and Munich. He was a senior consultant at Arthur D. Little Inc. and head of health economics at Roche in Basel. He holds a medical degree from the University of Basel, an MBA from the University of St. Gallen, a Master of Public Health from Harvard University, an LL.M. from the University of Zurich and a Doctorate in Law from the Private University of Liechtenstein. Thomas Szucs is a specialist in both Pharmaceutical Medicine and Prevention and Public Health. He has published more than 300 papers. He has been a clinician in genomic medicine since 2013.
 

Claudia Seitz
Prof. Dr. iur., M.A. (King´s College London), Attorney-at-Law
University of Ghent
Chair

Claudia Seitz is visiting professor at the University of Ghent, Faculty of Law and Criminology. Additionally, she is lecturer at the Faculties of Law of the Universities of Basel and Bonn, as well as director of the »CAS Medical Law: Law of Human Research, Pharmaceuticals and Genomics« at the Faculty of Law of the Private University in the Principality of Liechtenstein (UFL). She is also partner at the law firm Seitz & Riemer, founded in 1999, specialized in life sciences law, and has extensive scientific and practical experience in the life sciences sector. Previously, she was i.a. the Max Geldner assistant professor at the Faculty of Law of the University of Basel and in-house legal counsel at an international life sciences company in Basel. Claudia Seitz does advisory work as legal expert and is lecturer for international organisations and the European Commission as well as other institutions such as the Leibnitz Institute. She is a member of several advisory boards, such as the European Association for Health Law (EAHL) and the German Association for Synthetic Biology (GASB). She is also a board member of Ethics and Compliance Switzerland (ECS) as well as a member the editorial board of the European Pharmaceutical Law Review (EPLR) and the editorial advisory board of the Europäische Zeitschrift für Wirtschaftsrecht (EuZW). Her teaching, research and legal advisory activities focuses on life sciences, health, biotechnology, pharmaceutical, medical devices, data protection, IP and competition law as well as the regulation of new technologies.



Elvira Valverde Garcia
MLaw, Global Privacy Counsel
F. Hoffmann-La Roche Ltd

Elvira Valverde Garcia is a Spanish qualified lawyer with a Master Degree in Intellectual Property Law, New Technologies and Data Privacy. Elvira is currently a Global Privacy Counsel at Roche in the Group Legal Department in Basel, Switzerland. Prior to her current role at Roche, Elvira served as Legal and Compliance Counsel at Baxter Healthcare S.A. in Zurich, Switzerland. Previously, she held legal roles at GlaxoSmithKline S.A. and CMS law firm in Spain.

 

Time Table

15:30  Introduction: Data Transfer in international research projects, Claudia Seitz
15:40  Legal aspects of international research and development with genomic data, Thomas Szucs
16:10  Legal Challenges of Cross-Border Data Transfers in International Research Cooperation after Schrems II, Claudia Seitz
16:40  Cross-Border Data Transfers after Schrems II – Practical Steps for Organizations, Elvira Valverde Garcia
17:10  Round Table / Q&A
17:30  Conclusion

 

 

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Legal Aspects in Life Sciences 1
Compliance Management Systems in Life Sciences (Englisch)
23.09.2021
 

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Legal Aspects in Life Sciences 2
Integrität und Transparenz im Pharmabereich (Deutsch)
27.10.2021
 

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Legal Aspects in Life Sciences 3
Data Protection Compliance in the Health and Pharmaceutical Sector (Deutsch und Englisch)
17.11.2021
 

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