European Legislation & Regulation

Advancing Industry Interests in European Legislation and Regulation

With nearly 30 percent of all clinical trials taking place in Europe, ACRO engages with regulators to support – and provide the clinical research industry’s expertise on – harmonization efforts such as the EU Clinical Trial Regulation and the EU General Data Protection Regulation (GDPR).

ACRO’s European-focused Activities

  • Participate in invitation-only, recurring EMA stakeholder meetings on the development of the EU clinical trial portal and database, and provide Subject Matter Experts to invitation-only workshops and forums on specific issues such as pharmacovigilance.
  • Provide CRO expertise to the European Commission on the implementation of the Clinical Trial Regulation.
  • Build relationships with the national competent authorities that are responsible for human medicines.
  • Meet with the European Data Protection Supervisor (EDPS) to promote appropriate privacy and data protection regimes that protect data subjects and also facilitate research, including GDPR.
  • Advocate for a competitive business environment for clinical trial placement in Europe.
  • Collaborate with colleague associations such as the European Federation of Pharmaceutical Industries and Associations (EFPIA) on issues of common interest to present a unified and coordinated message to policymakers.

Read ACRO’s full history of regulatory comments on proposed guidances and rules in Europe that would impact clinical research and technology organizations.

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