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
Co-sponsorship
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
Agenda:
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
Transparency
Informed consent
Co-sponsorship
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
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
Speakers:
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.
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