Legal Aspects in Life Sciences 1

Compliance Management Systems in Life Sciences

In April 2021, ISO published its International Standard on Compliance Management Systems. ISO Management System Standards represent best international practice and should be implemented or at least considered as a benchmark for diligent management by all organizations.

Focus

ISO Standard 37301 on Compliance Management Systems – Key Aspects for Life Sciences
Daniel Bühr
  • The ISO Compliance Management System Concept; 
  • The Decisive Drivers of Compliance; 
  • What is Key under ISO 37301 for Life Sciences
The life sciences industry faces some industry specific compliance challenges and risks. What are these types of risks and what do specifically life sciences organizations need to consider regarding their governance and their compliance management in order to be effective and meet stakeholder expectations?
 
 
The evolution of Bayer’s Compliance management system 
Patrick Wellens
  • Changing scope and methodology over time
  • From a decentralized to a more centralized approach 
Insight in the organizational structure, roles and responsibilities of the Compliance department as well as the components (and how these changed over time) of the compliance management system.
 
 
Compliance Program Measurement from a Companies Perspective
Rauno Hoffmann
  • Expectations from internal and external stakeholders
  • Design and implementation of organisational, procedural, and technical measures 
  • Sufficient and effective detection and prevention of misconduct. 
In order to ascertain whether a compliance program is effective, its measurement is a key instrument to provide the required answers. It will not only enable compliance professionals to understand if the program works in practice, to identify gaps or areas of improvements. 
 
 
Fragerunde/ Round Table with the speakers (30 Min)
 
 

Speakers

Daniel Bühr
Dr. iur., Partner
LALIVE Attorneys at Law 

Daniel Lucien Bühr advises and represents clients in governance matters and in internal and external investigations. Daniel Bühr also regularly reviews and monitors corporate and public sector risk and compliance management systems. He is a member of the ISO Working Groups on Governance of organizations and on Compliance management systems. He is a member of the International Association of Independent Corporate Monitors, a founding member of the International Academy of Financial Crime Litigators and Honorary Chairman of Ethics and Compliance Switzerland, a not-for-profit association which promotes organizational ethics and compliance.



Rauno Hoffmann
Global Head Policies, Advisory & Anti-Bribery Program
Novartis

Rauno Hoffmann is an Ethics, Risk & Compliance Professional and leads the Global Policies, Advisory & Anti-Bribery Program team at Novartis. In this role, he is responsible for overseeing the company’s Anti-Bribery Program and for establishing and managing standards and policies pertaining to Ethics, Risk & Compliance.
Prior to joining Novartis, he gained extensive experience in various leadership roles at PricewaterhouseCoopers where he advised national and international clients on Risk, Compliance and Corporate Governance topics.
Rauno Hoffmann serves as a Vice Chair of the Anti-Corruption Task Force at Business at OECD as well as a Deputy Co-Chair of the B20 Integrity & Compliance Task Force under the G20 presidencies of Saudi Arabia in 2020 and of Italy in 2021. He is a member of the Working Group Compliance at SwissHoldings.

 



Patrick Wellens
Compliance Business Partner CH
Bayer Consumer Care AG

Patrick Wellens works since 2014 for Bayer Consumer care AG as a local and global compliance business partner. He has implemented the Bayer compliance management system in the various legal entities in Switzerland and supports the Global compliance team with a number of projects. Prior to Bayer he worked as an Corporate audit manager with Merck and as a senior manager with Big4 he provided fraud prevention, detection, investigations and compliance advisory services to life sciences and manufacturing clients. He is a Board member and Co-Chair of the working Group Life Sciences of Ethics and Compliance Switzerland. He is teaching Compliance Management at Fachhochschule Nordwestschweiz, member of the editorial board of the Society for Corporate Compliance and Ethics (SCCE) and has published various articles in the SCCE magazine (Cosmos). Patrick is a certified fraud examiner, certified internal auditor, and certified Compliance and Ethics Professional. 



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.

 

Time Table

15:30  Introduction: The Importance of Compliance Management Systems, Claudia Seitz
15:40  ISO Standard 37301 on Compliance Management Systems, Daniel Bühr
16:10  The evolution of Bayer’s Compliance management system, Patrick Wellens
16:40  Compliance Program Measurement from a Companies Perspective, Rauno Hoffmann
17:10  Q&A
17:40  Conclusion
 

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