Karen has over 30 years of industry experience in regulatory operations, information management, and compliance, and is currently a member of the EMA SPOR Taskforce supporting the implementation of IDMP iteration 1. As head of Calyx RIM Consulting, she leads a team of regulatory experts who provide strategic regulatory input into the software development lifecycle of Calyx RIM and advise clients on how to effectively manage complex regulatory processes in alignment with the changing regulatory landscape.

 

 

 

Darren has 25 years in the pharmaceutical industry with experience, knowledge and expertise gained within Regulatory Information Management, Regulatory Affairs, Compliance and Quality Assurance. He currently provides regulatory and consulting services for the implementation and operational use of the Calyx Regulatory Information Management (RIM) system, specializing in EU procedures, XEVMPD, IDMP and Combination Products. Customer focused, Darren supports clients to optimise their use of the RIM system and provides “fit for purpose” solutions to the client’s constantly evolving requirements.

 

 

 

For more than 15 years, Stephan has managed numerous Regulatory Information Management (RIM) projects and complex data migrations. With both technical and business expertise, he has assisted numerous clients with XEVMPD and IDMP implementations, also working with Calyx RIM Product Management as a subject matter expert.

As a RIM Product Owner, Julia works closely with Calyx’s Engineering and Regulatory Consultants teams to implement IDMP features within Calyx RIM, leveraging her extensive Article 57 experience capturing data and managing XEVMPD submissions. Her expertise includes Registration Planning & Tracking and Product Detail Management, with a focus on XEVMPD and IDMP.