EU Clinical Trial Regulation: Overview and Implementation

Topics

• 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

Who should Attend

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