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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

20-21 Oct 2022

& 20-21 Feb 2023 , 22-23 May 2023 , 13-14 Jul 2023 , 13-14 Nov 2023

Book or reserve now

Details

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.

Programme

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

Presenter

Laura Brown (More...)

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.

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Book or reserve now

NEW higher discounts for booking multiple places - 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

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
20-21 Oct 2022
Live webinar
09:30-16:30
UK (London)
20-21 Oct 2022
Live webinar
09:30-16:30
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 15 Sep*
Enrol now
to attend Live webinar
20-21 Feb 2023
Live webinar
09:30-16:30
UK (London)
20-21 Feb 2023
Live webinar
09:30-16:30
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 16 Jan 23*
Enrol now
to attend Live webinar
22-23 May 2023
Live webinar
09:30-16:30
UK (London)
22-23 May 2023
Live webinar
09:30-16:30
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 17 Apr 23*
Enrol now
to attend Live webinar
13-14 Jul 2023
Face-to-face, Rembrandt Hotel London
13-14 Jul 2023
Face-to-face
Rembrandt Hotel London
GBP 1,499 1,299
EUR 2,149 1,869
USD 2,449 2,137
Until 8 Jun 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 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
13-14 Nov 2023
Live webinar
09:30-16:30
UK (London)
13-14 Nov 2023
Live webinar
09:30-16:30
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 9 Oct 23*
Enrol now
to attend Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Abbott Healthcare Products B.V.
  • Ablynx
  • Alfasigma Sp.A.
  • ALK-Abello A/S
  • Aspen Pharma Trading Limited
  • Baxter R&D sprl
  • Biomarin
  • Blue Reg Pharma Consult
  • CHEMIDEX PHARMA LTD
  • CSL Behring UK Ltd
  • Drug Safety Solutions Limited
  • FAES FARMA
  • Galapagos
  • Incyte Europe
  • Jazz Pharmaceuticals
  • JWC
  • LEO Pharma
  • Leo Pharma A S
  • Life Molecular Imaging GmbH
  • Menarini Ricerche
  • Merus NV
  • Novo Nordisk A/S
  • Novo Nordisk A/S.
  • Octapharma Pharmazeutika Produktionsges.m.b.H.
  • Oxford BioMedica
  • PRA Health Sciences
  • stallergennes SAS
  • Takeda Pharmaceuticals International AG
  • Theravance Biopharma Ireland Limited
  • USGI Medical

Laura is a good speaker, keep the attention. The content was in line with the expectation.

Margherita Lerro, Study Manager, Menarini Ricerche, May 22

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 22

Very thorough and covered a lot of topics

Christine Woodward, Pharmacovigilance Manager, Drug Safety Solutions Limited, Feb 22

I think overall the webinar very good, instructive and informative.

Ban Eshqi, Scientific Affairs Pharmacist, CHEMIDEX PHARMA LTD, Apr 21

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 21

The small group allowed for good interaction between participants.

Jacques Wodelet , Quality Manager , JWC, Oct 19

Professional, engaging, informative, useful.

James O'Donoghue, Director Medical Writing, PRA Health Sciences, Apr 19

I think this course has been very good.

Sidse Schjøtz, Complinace Manager, ALK , Apr 19

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 17

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 , Jan 17

Lots of info, good content, pleasant speaker and very knowledgeable.

Francine Galibert, Incyte Europe, Jan 17