EU Clinical Trial Regulation: Overview and Implementation is a conference that covers topics such as:
- The implications of having a regulation instead of a Directive
- The NEW Clinical Trial Regulation
- Clinical trial authorisation process
- Clinical trial transparency
- Safety reporting
- Co-sponsorship concept
- Trials with authorized medicinal products
- Trials in emergency situations
- Non-EU sponsors
- Risk-based considerations
- Pharmacovigilance
- Requirements for managing investigational medicinal products
- Regulatory inspection
EU Clinical Trial Regulation: Overview and Implementation brings together attendees from:
- Clinical research
- Regulatory
- Project management
- Clinical operations
- Quality assurance (GCP auditors)
- Pharmacovigilance
- Study sites
- Vendor/CRO professionals
- Other professionals in pharmaceutical and biotechnology organisations
