Module 5 Presentations

19/07/2024

GDPR and Clinical Trials

• Approach of authorities in EU/UK is inconsistent. • Some authorities require consent to be both legal basis and Art 9 condition (e.g. Germany) • Others (e.g. UK, HRA) consider consent to be inappropriate and require use of legitimate interests and public health

The Organisation for Professionals in Regulatory Affairs

15

• Warnings/ Infringement Notice • GCP/GLP/PhV Inspections • Discounting of “non-GCP” data by regulators (Directive 2001/83) • Administrative action/fines/prosecution • % global turnover • Effect on CT authorisation - revocation/suspension/variation • Effect upon relationship with regulator Enforcement and Sanctions - Consequences of non-compliance

The Organisation for Professionals in Regulatory Affairs

16

8