Clinical Trial Regulatory Requirements is organized by Management Forum (Mf) Ltd and will be held from Jul 08 - 09, 2019 at The Rembrandt Hotel, London, England, United Kingdom.
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 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 and existing Directive requirements. Key US requirements which impact on 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 current requirements of the EU Clinical Trials 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
• ICH GCP R2 guideline requirements
• Regulatory inspections
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 536/2014
• Discuss the impact of Brexit
• 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
• Understand key FDA requirements
Who should attend?
This course is ideal for anyone requiring either an overview or refresher of the current clinical trial regulatory and guideline requirements and an update on the new EU Clinical Trial Regulation. It will be particularly relevant for those working in regulatory, clinical research, clinical operations, project management and 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 any other professionals who want to know more about regulations and guidelines covering clinical trials.
• Conference Fee: EUR 2099
• Conference Fee: USD 2338
Additional details will be posted as soon as they are available.
|Contact No. :||+44 (0)20 7749 4730
Conference Fee Details
|Conference Fee||:||GBP £1499.00|
|Early Fee Last date||:||NA|