Clinical Trial Regulatory Requirements
Are you up to date with the regulatory requirements for clinical research in the EU and key requirements in the US?
Do you understand the impact of the new requirements of the EU Clinical Trials Regulation?
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the EU Clinical Trial Regulation, ICH GCP R3 update, a brief review of key FDA requirements and update of other recent changes.
This interactive programme will highlight the most important of these key requirements and changes and how these are likely to impact on trials now and in the future for pharmaceutical and biotechnology companies and study sites.
Key topics to be covered include:
- The EU Clinical trials Regulation (536/2014) and update
- The New Clinical Trial Information System (CIS)
- Clinical trial authorisation
- Complexities for running paediatric trials
- Requirements for managing investigational medicinal products
- Legal aspects of clinical trials
- Requirements for pharmacovigilance
- ICH GCP R3 update
- Regulatory inspections
Upcoming start dates
Suitability - Who should attend?
Benefits of attending
- Decipher the framework of clinical trial regulations and guidelines in Europe
- Gain an update on the new EU Clinical Trial Regulation 536/2014
- Review key FDA requirements
- Understand clinical trial authorisations
- Assess the most important legal aspects of clinical trials
- Ensure you comply with pharmacovigilance and adverse event reporting
Request information - obligation free
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Content: Fantastic content and material that would help organisations to prepare for the transition into the CTR Presentation: Well presented information especially with the in...