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Course description

Course type

Advanced

Course description

The evolving landscape of MAR clinics calls for robust quality management systems that ensure compliance with increasingly complex regulations. Blending theory with practice, this workshop will explore key quality control processes and regulatory frameworks that impact the safety and efficacy of MAR.

 

Target audience

Clinicians, embryologists, laboratory directors, quality managers, regulatory affairs specialists, policy-makers, and those involved in the ethical aspects of ART.

 

Educational needs and expected educational outcomes

Professionals in the field need to stay updated on best practices, risk management strategies, and how to effectively navigate inspections. Attendees will come away with an understanding of both the regulatory and practical aspects of quality management including significant updates to new European legislation, particularly the Substances of Human Origin (SoHO) Regulation in August 2027. Participants will also learn how to improve efficiency and safety in the clinic with practical sessions on quality management principles such as root cause analysis; failure mode and effects analysis; and risk management.

 

Innovative aspects of the course

This course enables participants to apply what they've learned to simulated scenarios. Moreover, it will prepare participants for the SoHO Regulation which will shape future practices in IVF clinics. The course also includes interactive discussions on the regulatory readiness needed to meet these new standards, offering practical strategies for compliance and team readiness.

 

Educational methods

  • Lectures from leading experts
  • Interactive roundtable discussions
  • Group work on practical risk management scenarios
  • Hands-on sessions with RCA, FMEA, and MiRCA tools
  • Case studies and peer discussions

Language

The official language of the course is English.