EU Clinical Trial Regulation: Overview and Implementation

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

EU Clinical Trial Regulation: Overview and Implementation will be held in London, United Kingdom on 20-21 Apr 2021.