The CTR, which became applicable on 31st January 2022, is directly effective in all EU Member States and introduced the biggest change to the legal framework surrounding clinical trials since the Clinical Trials Directive was implemented. The CTR has already had a global impact as all interventional trials that take place even partially in an EU Member State need to comply with its regulatory requirements, at every stage of the trial life cycle.
This course will provide an essential understanding of the new Regulation and key associated implementing acts and other texts for carrying out clinical trials in the EU. It will provide an essential understanding to help with compliance with the new Regulation and key associated implementing acts and other texts for carrying out clinical trials in the EU. The programme will highlight the most important of these key requirements and how these have impacted so far on trials for biopharmaceutical companies, vendors and study sites since going live in 2022.
This will include explaining how the regulation has harmonised procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial CTIS (Clinical Trial Information System).
Benefits of attending:
- Gain an overview of the Clinical Trial Regulation and changes for trials in the EU
- Understand the new Clinical Trials Information system (CTIS) and experience so far
- Share experiences of implementing the Clinical Trials Regulation
- Discuss the Clinical Trial Regulation implementation documents
- Understand the EU clinical trial authorisation process and experience
Key topics to be covered include:
- Clinical Trials Information System
- Clinical trial authorisation process
- Safety reporting
- Requirements for managing investigational medicinal products
- Clinical trials conducted on children
- Regulatory inspection
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
