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.
24-25 Jan 2019
& 8-9 Jul 2019
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:
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.
Understand the current framework of clinical trial regulations in Europe
Overview and review of key areas of the EU Clinical Trial 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
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
Awareness of other recent EU and FDA developments in clinical trial requirements including:
Brief considerations for preparing for regulatory inspection
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.