The speaker of this internal training event of our company addressed the topic “Risk-Based Quality Management” as an expert on regulatory requirements and upcoming changes in the field of drug development. In her role as Global Coordinator – Project Compliance Management in a leading pharmaceutical company, she was able to contribute her broad range of experience.

Particularly exciting were her explanations regarding the identification and prioritization of risks, risk control, implementation strategy and how to deal with any remaining risks.

It was vividly demonstrated to all participants that a rethink may also be necessary in our own company and that procedures need to be adapted.