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Regulatory Affairs

The objectives of the ESC in the field of Regulatory affairs are:

  • To ensure an open dialogue with regulatory authorities related to identified topics
  • To share expert advice with regulatory authorities regarding procedures and principles related to cardiovascular regulatory aspects, and in particular :
    • contribute to the revision of the regulatory process for cardiovascular devices
    • encourage a structure to monitor post-approval studies
    • Assist in shaping the design of clinical trials and post marketing surveillance registries
    • Engage reflection in new areas currently ill regulated, such as biotech and cell-based therapies

The ESC has also been involved in the work of the EMEA Health Care Professionals Working Group.