European Legislation & Regulation
Advancing Industry Interests in European Legislation and Regulation
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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