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.
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
Laura Brown (8-9 Jul 2019)
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.
| 8-9 Jul 2019 | |||
| 8-9 Jul 2019 | Rembrandt Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Enrol now |
| 30-31 Jan 2020 | |||
| 30-31 Jan 2020 | Venue not yet confirmed | + VAT @ 20.00% |
Enrol now |
“[The speaker has] ...a solid background related to EU and US regulation and she shares her opinion in a respectul and thoughful way. ”
Leonardo Roque Pereira, Global Patient Safety Senior Scientist, Ipsen Biopharm Ltd.
“The content of the course is quite comprehensive and the information provided is highly helpful and useful.”
Mariia Sorokina, Clinical Covigilance Specialist, Aspen Pharma Trading Limited
“Very interesting course, good speaker, she was very knowledgable but went over some topics quite quickly”
Chantal Mutsaers, Regulatory Affairs Scientist, Phara Plus Life Science Services
“Content was correct as an overview, duration was 'not too long' and the speaker (Laura Brown) was concise, direct and straight to the point. Very good!”
Russell Pursell, Manufacturing Manager, Quay Pharma
“Fantastic, clear, enthusiasm and delivered with a little humour which made it feel interesting and relaxed as opposed to too professional and boring! Would definitely recommend!”
Vikesh Lad, Pharmaceutical Assessor, MHRA
“Very helpful and useful for my job”
Anna Zaragoza, Technician, Grifols S.A.
“Many thanks for all the additional material.”
Gabi Schidler, Senior Manager, Pharmacovigilance, Horizon Pharma GmbH