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.

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.