Clinical Trial Regulatory Requirements
Are you up to date with the regulatory requirements for clinical research?
Do you understand the impact and new requirements of the EU Clinical Trials Regulation and delegated acts and guidelines?
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation, the new ICH GCP (R2) guideline and existing Directive requirements. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.
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
Why you should attend
- Decipher the framework of clinical trial regulations and guidelines in Europe
- Gain an update on the new EU Clinical Trial Regulation and the recently finalised ICH GCP R2 Guideline
- Discuss the impact of Brexit
- Understand clinical trial authorisations: regulatory and ethical approval n Realise the most important legal aspects of clinical trials
- Ensure you comply with pharmacovigilance and adverse event reporting
- Make certain you are prepared for regulatory inspections
Who should attend?
This course is ideal for anyone requiring an overview or refresher of the current clinical trial regulatory and guideline requirements and an update on the new EU Clinical Trial Regulation. The course is relevant for those working in regulatory, clinical research, clinical operations, project management, quality assurance (GCP auditors), vendor/CRO professionals, study sites and other professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products. It will also be of interest to those departments who liaise/support clinical trial personnel (such as clinical trial supply, pharmacovigilance, quality assurance, document management, legal, regulatory authorities, and all other professionals who want to know more about regulations and guidelines covering clinical trials.