This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU
The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new clinical trial database and portal. Once the electronic portal and database are fully functional and the European Commission has given its approval, it will take six months to become applicable. Guidelines for enacting the new Regulation have also been prepared in a number of areas including inspection, investigational medicinal products and trial documentation.
This course will provide an essential understanding to help with compliance with the new Regulation and associated implementing acts and other texts for carrying out clinical trials in the EU. The programme will highlight the most important of these key requirements and changes and how these are likely to impact on trials for biopharmaceutical companies, CROs and study sites.
Benefits of attending:
- Gain an overview of the Clinical Trial Regulation and changes for trials in the EU
- Review how the new Regulation differs from the previous Clinical Trials Directive
- Discuss the Clinical Trial Regulation delegated acts and other implementation documents
- Understand the new EU clinical trial authorisation process, including considerations for the UK
Key topics to be covered include:
- Implications of having a regulation instead of a directive
- Clinical trial transparency
- Clinical trial authorisation process
- Safety reporting
- Trials with authorised medicinal products
- Risk-based considerations
- Non-EU sponsors
- Requirements for managing investigational medicinal products
- Clinical trials conducted on children
- Regulatory inspection
Background to the EU Clinical Trial Regulation (536/2014)
- The development of European clinical trial legislation
- The framework of clinical trial regulations in Europe
- Overview of the current Clinical Trials Directive requirements
- Problems with the Clinical Trials Directive
- Directive vs Regulation - what are the main differences?
Changes in the new EU Clinical Trial Regulation
- Overview of the major new requirements of the Regulation including:
- Risk-based evaluations
- Non-EU sponsors
- Informed consent
EU Clinical Trial Regulation documents
- Serious breaches
- Risk-proportionate approaches in clinical trials
- Summaries of clinical trial results for laypersons
- ICH GCP (R2)
- New requirements for the trial master file
- Q&A document
Clinical trial regulatory authorisation and ethical approval
- The significant changes in clinical trial approval in the EU
- The new clinical trial authorisation process
- Substantial modifications
Investigational medicinal product/auxiliary product guidelines
- GMP requirements
- Key requirements for IMPs and AMPs (auxiliary medicinal products)
- Requirements for labelling and packaging
Pharmacovigilance and adverse event reporting
- Adverse event reporting - requirements and definitions
- Safety reporting requirements
- RSI (reference safety information)
Considerations for clinical trials conducted with minors
- EU guidance for running clinical trials on children
- Assent and consent
- Key differences and requirements for running clinical trials on children compared to adults
Considerations for regulatory inspection
- GCP and GMP inspection guidelines
- How to prepare for inspection under the new EU clinical trial requirements
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of Cardiff
Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
This event is ideal for anyone requiring an update on the EU Clinical Trial Regulation (536/2014). The course is relevant for those working in regulatory, clinical research, clinical operations, project management, pharmacovigilance, 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 with/support clinical trial personnel, and all other professionals who want to know more about this important new regulation.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.