The "Clinical Trial Regulatory Requirements" conference has been added to ResearchAndMarkets.com's offering.
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 existing Directive requirements. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.
Attending this course will help ensure you are familiar with the regulatory requirements for running clinical trials and with these recent developments. The course 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, biotechnology companies and study sites.
Key topics to be covered include:
- The current requirements of the EU Clinical Trial Directive
- The EU Clinical Trial Regulation (536/2014)
- The impact of Brexit
- Clinical trial authorisations
- Complexities for running paediatric trials
- Requirements for managing investigational medicinal products
- Legal aspects of clinical trials
- Requirements of pharmacovigilance
- New ICH GCP R2 guideline requirements
- Regulatory inspection
Agenda
Programme Day One
- Understand the current framework of clinical trial regulations in Europe
- Overview and review of key areas of the EU Clinical Trial Directive
- Brief overview of the GCP Directive
- The new EU Clinical Trial Regulation and how this will replace the EU Clinical Trials Directive
- Clinical trial regulatory authorisation and amendments
- Clinical Trial Application (CTA) and how this will change with the new Clinical Trial Regulation
- Ethics Committee (EC) submissions and approval
Programme Day Two
- Running clinical trials in children the paediatric plan and ethical considerations
- Brief overview of legal aspects of clinical trials
- Investigational medicinal product
- Pharmacovigilance and adverse event reporting
- Brief overview of other recent EU and FDA developments in clinical trial requirements
- Brief considerations for preparing for regulatory inspection
- Summary and close
For more information about this conference visit https://www.researchandmarkets.com/research/n2q4nw/clinical_trial?w=4
View source version on businesswire.com: https://www.businesswire.com/news/home/20181207005485/en/
Contacts:
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
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Related Topics: Clinical Trials, Medical Law