Regulatory Affairs

ENABLER: Francia Vargas

OBJECTIVE:

Providing a space for the review of critical regulatory affairs with the objective of jointly agreeing on strategies to resolve the bottlenecks detected and generate the necessary regulatory environment for the development of a greater number of clinical studies in Colombia.

  • Strengthen the link with the regulatory agency to keep all clinical research stakeholders informed of local governmental needs and requirements.
  • Facilitate interaction between CROs and sponsors in order to harmonize regulatory processes, improve the quality and timing of operations, thus strengthening the country’s image in clinical research.
  • Locally disseminate the role of research actors and their potential as partners in clinical research.
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