Presented by
Management Forum
EU (European Union) Clinical Trial Regulation 536/2014: Overview and Implementation Experience Training Course
This course will provide an update on the experience of working to the regulation since Go-live, to help your implementation and compliance including transferring clinical trials from the directive to the regulation.
★★★★★ "This was a very detailed and great overview of the CTR and I would recommend following this course i... more (11)"
11-12 November 2024
+ 13-14 February 2025, 2-3 June 2025, 13-14 October 2025 »
from £1099
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
- Clinical Quality Management Systems
- Clinical Trial Regulatory Requirements
- EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience
- GCP and Clinical Research Update - Hot Inspection Topics
- Managing Service Providers including CRO and CMOs oversight to comply with ICH GCP R3
- Introduction to Good Clinical Practice (GCP)
Course overview
The CTR, which became applicable on 31st January 2022, is directly effective in all EU Member States and introduced the biggest change to the legal framework surrounding clinical trials since the Clinical Trials Directive was implemented. The CTR has already had a global impact as all interventional trials that take place even partially in an EU Member State need to comply with its regulatory requirements, at every stage of the trial life cycle.
This course will provide an essential understanding of the new Regulation and key associated implementing acts and other texts for carrying out clinical trials in the EU. It 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 have impacted so far on trials for biopharmaceutical companies, vendors and study sites since going live in 2022.
This will include explaining how the regulation has harmonised 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).
Benefits of attending:
- Gain an overview of the Clinical Trial Regulation and changes for trials in the EU
- Understand the new Clinical Trials Information system (CTIS) and experience so far
- Share experiences of implementing the Clinical Trials Regulation
- Discuss the Clinical Trial Regulation implementation documents
- Understand the EU clinical trial authorisation process and experience
Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.
Key topics to be covered include:
- Clinical Trials Information System
- Clinical trial authorisation process
- Safety reporting
- Requirements for managing investigational medicinal products
- Clinical trials conducted on children
- Regulatory inspection
Who should attend?
This event is ideal for anyone requiring an understanding and update on the EU Clinical Trials 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.
This 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
- Experience and challenges so far since Go Live
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
- Requests for information
- End of study reports
The new CTIS (Clinical Trial Information System)
- What is CTIS?
- How to use CTIS
- CTIS training
- Transitioning to the regulation
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
Independent Pharmaceutical Consultant
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and QA Consultant.
Laura has more than 25 years of 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 the author of several articles on the EU Clinical Trials Regulation, The Planning of International Drug Development in the Clinical Research Manual and has written a chapter in International Pharmaceutical Product Registration.
Laura has consulted with several companies for the implementation of the CTR internationally.
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*
Please contact us for pricing if you are interested in booking 5 or more delegates
11-12 November 2024
Live online
09:30-16:30 UK (London) (UTC+00)
10:30-17:30 Paris (UTC+01)
04:30-11:30 New York (UTC-05)
Course code 14005
- GBP 1,299
- EUR 1,869
- USD 2,129
- 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
Not ready to book yet?
for 7 days, no obligation
13-14 February 2025
Live online
09:30-16:30 UK (London) (UTC+00)
10:30-17:30 Paris (UTC+01)
04:30-11:30 New York (UTC-05)
Course code 14508
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 09 Jan
- 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
Not ready to book yet?
for 7 days, no obligation
2-3 June 2025
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 14875
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 28 Apr
- 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
Not ready to book yet?
for 7 days, no obligation
13-14 October 2025
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 15052
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 08 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
Not ready to book yet?
for 7 days, no obligation
* 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; and apply only when booking multiple delegates on the same date.
Reviews of IPI's EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience training course
Laura is a good speaker, keep the attention. The content was in line with the expectation.
May 23 2022
Margherita Lerro 
Study Manager, Menarini Ricerche
Feb 21 2022
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.
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
Denmark
- ALK
- ALK-Abelló
- ALK-Abello A/S
- H. Lundbeck A/S
- KLIFO A/S
- LEO Pharma
- Leo Pharma A S
- Lundbeck
- Novo Nordisk A/S
- Novo Nordisk A/S.
- Novo Nordisk A/S. Company Member
- Zealand Pharma
United Kingdom
- Alcon-Novartis
- Biomarin
- Blue Reg Pharma Consult
- CHEMIDEX PHARMA LTD
- CSL Behring UK Ltd
- Drug Safety Solutions Limited
- Jazz Pharmaceuticals
- Mediscribe Consulting Ltd
- Oxford Biomedica
- PRA Health Sciences
- Smith & Nephew
Netherlands
- Abbott Healthcare Products B.V.
- Byondis B.V.
- Galapagos
- HAL Allergy BV Leiden
- Merus NV
France
- Indivior France
- JWC
- STALLERGENES
- stallergennes greer
Italy
- Alfasigma Sp.A.
- Chiesi Farmaceutici SPA
- Indivior
- Menarini Ricerche
Switzerland
- CUTISS AG
- Incyte Europe
- Takeda Pharmaceuticals International AG
Austria
- Octapharma Pharmazeutika Produktionsges.m.b.H.
- Takeda/Baxalta
Belgium
- Ablynx
- Baxter R&D sprl
Germany
- Christian Hucke Pharma Consulting and Services
- Life Molecular Imaging GmbH
Ireland
- Aspen Pharma Trading Limited
- Theravance Biopharma Ireland Limited
Canada
- Medicenna Therapeutics
Spain
- FAES FARMA
Sweden
- Link Medical AB
United States of America
- USGI Medical
Run EU Clinical Trial Regulation 536/2014: Overview and Implementation Experience Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee, based on 10 attendees
- 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 experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
