DUBLIN–(BUSINESS WIRE)–The “Clinical Trial Regulatory Requirements Training Course” training has been added to ResearchAndMarkets.com’s offering.
Are you up to date with the regulatory requirements for clinical research?
Do you understand the impact and new requirements of the EU Clinical Trial Regulation?
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and CTIS (Clinical Trial Information system) going live on the 31st January 2022. Key US requirements which impact trials being carried out in Europe will also be briefly covered.
The 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 Trial Regulation (536/2014)
- The New Clinical Trial Information System
- How the Clinical Trial Regulation compares with the EU Clinical Trial Directive
- 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
- 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: regulatory and ethical approval
- Assess the most important legal aspects of clinical trials
- Ensure you comply with pharmacovigilance and adverse event reporting
For more information about this training visit https://www.researchandmarkets.com/r/f5ju9d
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
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