Presented by
Management Forum
EU (European Union) Clinical Trial Regulation 536/2014: Overview and Implementation Training Course
This course will provide an essential understanding to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU
★★★★★ "This was a very detailed and great overview of the CTR and I would recommend following this course i... more"
23-24 May 2022 + 2 more dates
- Format: Live online, Classroom
- CPD: 12 hours for your records
- Certificate of completion
Course overview
The new EU Clinical Trial Regulation (536/2014) replaces the European Clinical Trials Directive (2001/20/EC) in 2022. 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 CTIS (Clinical Trial Information System).
This course will provide an essential understanding to help with compliance with the new Regulation and key 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 how these are likely to impact on trials for biopharmaceutical companies, vendors 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
- Understand the new CTIS
- Discuss the Clinical Trial Regulation implementation documents
- Understand the new EU clinical trial authorisation process, including considerations for the UK
Key topics to be covered include:
- New Clinical Trials Information System
- 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
Who should attend?
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.
The EU Clinical Trial Regulation 536/2014: Overview and Implementation course will cover:
Background to the EU Clinical Trial Regulation
- The development of European clinical trial legislation
- The framework of clinical trial regulations in Europe
- Problems with the Clinical Trials Directive
- Directive vs Regulation – what are the main differences?
Overview of the key requirements and changes
- Including:
- Roles and responsibilities
- Non-EU sponsors
- Transparency
- Co-sponsorship
Harmonisation templates
- Investigator Curriculum Vitae
- Declaration of interest template
- Site suitability
- Informed consent and patient recruitment procedure
- Compensation for trial participants
Clinical Trial Regulatory Authorisation
- The significant changes in clinical trial approval in the EU
- The new clinical trial authorisation process
- Substantial modifications
- Notices
- End of study reports
The new CTIS (Clinical Trial Information System)
- What is CTIS?
- How to use CTIS
- CTIS training
Clinical Trial Ethical Approval and Informed Consent
- Ethical approval considerations under the Regulation
- Informed consent changes under the regulation
EU Clinical Trial Regulation Documents
- Serious breaches
- Risk-proportionate approaches in clinical trials
- Summaries of clinical trial results for laypersons
- Q&A document
Manufacturing
- GMP requirements
- Key requirements for IMPs and auxiliary medicinal products
- Labelling and packaging
Safety reporting
- Adverse event reporting – requirements and definitions
- Safety reporting requirements
- Safety reporting including RSI (reference safety information)
Clinical Trials in Children
- Considerations for running clinical trials on children
- Assent and consent
- Key differences and requirements for running clinical trials on children compared to adults
Inspection preparation under the new regulation
- GCP and GMP inspection guidelines
- How to prepare for inspection in the EU under the new EU Clinical Trial Requirements
- TMF guideline documentation considerations for inspection
Laura Brown
Dr Laura Brown MBA,
BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and QA Consultant,
Course Director for the MSc Regulatory Affairs, TOPRA.
She has more than 25 years’ experience in the pharmaceutical industry including
clinical trial regulations. She has
worked as a clinical research manager, audit director and head of a training
department. Laura is an international expert on regulatory requirements in
clinical research and was Chair of the Institute of Clinical Research GCP Forum
for over six years. She writes regularly on clinical research regulatory
requirements and is author of several articles on the EU Clinical Trial
Regulation, ‘The Planning of International Drug Development’ in the Clinical
Research Manual and has written a chapter in International Pharmaceutical
Product Registration.
Book EU Clinical Trial Regulation 536/2014: Overview and Implementation Live online/Classroom training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
23-24 May 2022
Live online
09:30-16:30 UK (London) (UTC+01)
10:30-17:30 Paris (UTC+02)
04:30-11:30 New York (UTC-04)
Course code 11604
- GBP 1,299
- EUR 1,859
- USD 2,098
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,026 2,338
Until 30 May
- 2 days classroom-based training
- Meet presenters and fellow attendees in person
- Lunch and refreshments provided
- Download documentation and certification of completion
- Fair transfer and cancellation policy
20-21 Oct 2022
Live online
09:30-16:30 UK (London) (UTC+01)
10:30-17:30 Paris (UTC+02)
04:30-11:30 New York (UTC-04)
Course code 11731
- GBP 1,099 1,299
- EUR 1,579 1,859
- USD 1,786 2,098
Until 15 Sep
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Reviews of IPI's EU Clinical Trial Regulation 536/2014: Overview and Implementation training course
Very nice webinar which gave a good overview of the CTR and the CTIS portal. I liked the parts where the part 1 and part 2 was presented as I think this is not straightforward to understand. Also, I like the small quizzes that were done.
Feb 21 2022
Ellen Due Horup 
Compliance Manager, ALK-Abelló
Feb 21 2022
Very thorough and covered a lot of topics
Christine Woodward 
Pharmacovigilance Manager, Drug Safety Solutions Limited
Apr 22 2021
This was a very detailed and great overview of the CTR and I would recommend following this course if this new CTR has impact on your work or your company.
Leyla Nematollahi 
Regulatory Affairs Liaison, Galapagos
Apr 22 2021
I think overall the webinar very good, instructive and informative.
Ban Eshqi
Scientific Affairs Pharmacist, CHEMIDEX PHARMA LTD
Oct 7 2019
The small group allowed for good interaction between participants.
Jacques Wodelet 
Quality Manager , JWC
Apr 11 2019
Professional, engaging, informative, useful.
James O'Donoghue
Director Medical Writing, PRA Health Sciences
Apr 11 2019
I think this course has been very good.
Sidse Schjøtz
Complinace Manager, ALK
Jan 27 2017
Good overview of the new regulations, presented in an interesting and interactive way. Some of the practical case studies weren't that relevant for me, but hopefully benefitted others.
Helen Watts
Regulatory Affairs Manager, CSL Behring UK Ltd
Jan 27 2017
Lots of info, good content, pleasant speaker and very knowledgeable.
Francine Galibert 
Incyte Europe
Jan 27 2017
I like everything about Management forum Courses, hence my attendance for few years now, and I respect Laura's way of presentation, her patience, kindness and we always learn a lot from her. I do look for any opportunity to attend courses which are applicable to my day to day work as I found them useful. Any luck you may run again the All day event like you did couple of years ago, for free where few courses were taking place at the same time and where we could jump from one to another ...?Thanks for all
Hadjira Rezzoug
Senior RA Associate, Alcon-Novartis
United Kingdom
- Alcon-Novartis
- Biomarin
- Blue Reg Pharma Consult
- CHEMIDEX PHARMA LTD
- CSL Behring UK Ltd
- Drug Safety Solutions Limited
- GW Pharmaceuticals
- Mediscribe Consulting Ltd
- Oxford Biomedica
- PRA Health Sciences
- Smith & Nephew
Denmark
- ALK
- ALK-Abelló
- ALK-Abello A/S
- H. Lundbeck A/S
- LEO Pharma
- Leo Pharma A S
- Lundbeck
- Novo Nordisk A/S
- Novo Nordisk A/S.
- Novo Nordisk A/S. Company Member
France
- JWC
- STALLERGENES
- stallergennes greer
Italy
- Alfasigma Sp.A.
- Chiesi Farmaceutici SPA
- Menarini Ricerche
Netherlands
- Abbott Healthcare Products B.V.
- Galapagos
- Merus NV
Switzerland
- CUTISS AG
- Incyte Europe
- Takeda Pharmaceuticals International AG
Belgium
- Ablynx
- Baxter R&D sprl
Ireland
- Aspen Pharma Trading Limited
- Theravance Biopharma Ireland Limited
Austria
- Octapharma Pharmazeutika Produktionsges.m.b.H.
Germany
- Life Molecular Imaging GmbH
Spain
- FAES FARMA
Sweden
- Link Medical AB
United States of America
- USGI Medical
Run EU Clinical Trial Regulation 536/2014: Overview and Implementation Live online/Classroom for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements:
