With nearly 30 percent of all clinical trials taking place in Europe, ACRO engages with regulators to support – and provide CRO expertise on – harmonization efforts such as the EU Clinical Trial Regulation and the EU General Data Protection Regulation (GDPR).
EU Engagement Activities
- Participate in invitation-only, recurring EMA stakeholder meetings on the development of the EU 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 the EU.
- 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 more about ACRO’s legislative and regulatory policy goals: