Presented by
Management Forum
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.
27-28 Jan 2022 + 1 more date
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?
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:
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.
Dr Laura Brown is an independent QA and training consultant and director of the MSc in Clinical Research at Cardiff University’s School of Pharmacy. Laura has many years’ experience in the pharmaceutical industry, working for companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a clinical research manager, audit director and as head of a training department and is an international expert on regulatory requirements in clinical research. She was Chair of the Institute of Clinical Research GCP Forum for six years and writes regularly on clinical research regulatory requirements. She ha written several articles on the requirements of the EU Clinical Trial Regulation, the impact of Brexit on clinical trials and the ICH GCP R2 guideline.
27-28 Jan 2022
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11548
Until 23 Dec
14-15 Jul 2022
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 11681
Until 09 Jun
Very well organized in terms of content, very well presented, replies for every single question is addressed by the wonderful speaker and I truly enjoyed it and learned so much. Thank you it was excellent!
Jul 5 2021
Nurit Birenboim 
Regulatory Affairs Associate, Ayala Pharmaceutical
Jul 5 2021
Very interactive and stimulating.
Margherita Lerro 
Study Manager, Menarini Ricerche
Jan 28 2021
Laura was engaged the whole time and really made the presented topics interesting. She also clearly has a wealth of knowledge within the area, so could answer any questions. I liked that even though the course was online it was possible to have breakout into groups with participants talking and discussing together.
Anna Olevik 
Regulatory Affairs Manager, Camurus AB
Jan 30 2020
Laura was passionate, knowledgable and entertaining. I particularly liked the group work sessions, which gave us time to digest and use the information just obtained.
Josy Giordano 
Regulatory Affairs Manager, Nestec SA
Jan 24 2019
The course is very useful for people new to the field and also the more experienced. The speaker, Laura, was very knowledgeable and open to even the most basic questions on the topic presented.
Ini Okereke 
Regulatory Affairs Manager, GW Pharmaceuticals
Jan 24 2019
Useful and recommended for those who are advanced in that topic.
Magdalena Golos 
Senior Biopharmaceutics and Clinical Team Manager, Zaklady Farmaceutyczne Polpharma S.A.
Jan 24 2019
Laura was very knowledgable and made the course interactive. We had several group discussions which made the topics clear. The course was excellent and met the criteria I was looking for.
Paul Kelsall
Director of Clinical Manufacturing, Upperton Pharma Solutions
Jul 9 2018
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
Jan 25 2018
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
Jan 25 2018
Very helpful and useful for my job.
Anna Zaragoza 
Technician, Grifols S.A.
Jan 25 2018
Fantastic, clear, enthusiastic 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
Jan 25 2018
Very interesting course, good speaker who was very knowledgable.
Chantal Mutsaers 
Regulatory Affairs Scientist, Phara Plus Life Science Services
Jul 9 2018
[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.
Jul 10 2017
Many thanks for all the additional material.
Gabi Schidler 
Senior Manager, Pharmacovigilance, Horizon Pharma GmbH
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Spain
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Ireland
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Sweden
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Israel
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Poland
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United States of America
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