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EU (European Union) Clinical Trial Regulation: Overview and Implementation Training Course

This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU

10-11 Jan 2022

& 7-8 Apr 2022 , 4-5 Jul 2022 , 20-21 Oct 2022

Book now

Details

Course overview

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). 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 database and portal. Once the electronic portal and database are fully functional and the European Commission has given its approval, it will take six months to become applicable. Guidelines for enacting the new Regulation have also been prepared in a number of areas including inspection, investigational medicinal products and trial documentation.

This course will provide an essential understanding to help with compliance with the new Regulation and 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 changes and how these are likely to impact on trials for biopharmaceutical companies, CROs 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
  • Discuss the Clinical Trial Regulation delegated acts and other implementation documents
  • Understand the new EU clinical trial authorisation process, including considerations for the UK

Key topics to be covered include:

  • 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 (536/2014)

  • The development of European clinical trial legislation
  • The framework of clinical trial regulations in Europe
  • Overview of the current Clinical Trials Directive requirements
  • Problems with the Clinical Trials Directive
  • Directive vs Regulation – what are the main differences?

Changes in the new EU Clinical Trial Regulation

  • Overview of the major new requirements of the Regulation including:Risk-based evaluations
    • Non-EU sponsors
    • Transparency
    • Informed consent
    • Co-sponsorship

EU Clinical Trial Regulation documents

  • Serious breaches
  • Risk-proportionate approaches in clinical trials
  • Summaries of clinical trial results for laypersons
  • ICH GCP (R2)
  • New requirements for the trial master file
  • Q&A document

Clinical trial regulatory authorisation and ethical approval

  • The significant changes in clinical trial approval in the EU
  • The new clinical trial authorisation process
  • Substantial modifications

Investigational medicinal product/auxiliary product guidelines

  • GMP requirements
  • Key requirements for IMPs and AMPs (auxiliary medicinal products)
  • Requirements for labelling and packaging

Pharmacovigilance and adverse event reporting

  • Adverse event reporting – requirements and definitions
  • Safety reporting requirements
  • RSI (reference safety information)

Considerations for clinical trials conducted with minors

  • EU guidance for running clinical trials on children
  • Assent and consent
  • Key differences and requirements for running clinical trials on children compared to adults

Considerations for regulatory inspection

  • GCP and GMP inspection guidelines
  • How to prepare for inspection under the new EU clinical trial requirements

Presenter

Laura Brown (More...)

Dr Laura Brown is an independent QA and training consultant and Senior Lecturer of the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura has many years’ experience in the pharmaceutical industry, having worked for several leading companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. 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 now

Book now

10-11 Jan 2022
Face-to-face, (venue not yet confirmed)
10-11 Jan 2022
Face-to-face
(venue not yet confirmed)
GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 6 Dec*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 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
7-8 Apr 2022
Live webinar
7-8 Apr 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 3 Mar 22*
Enrol now
to attend
Live webinar
4-5 Jul 2022
Face-to-face, (venue not yet confirmed)
4-5 Jul 2022
Face-to-face
(venue not yet confirmed)
GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 30 May 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 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 webinar
20-21 Oct 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 15 Sep 22*
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

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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  • Abbott Healthcare Products B.V.
  • Ablynx
  • Alcon-Novartis
  • Alfasigma Sp.A.
  • ALK
  • Aspen Pharma Trading Limited
  • Baxter R&D sprl
  • Biomarin
  • Blue Reg Pharma Consult
  • CHEMIDEX PHARMA LTD
  • Chiesi Canada Corp
  • CSL Behring UK Ltd
  • FAES FARMA
  • Galapagos
  • H. Lundbeck A/S
  • Incyte Europe
  • JWC
  • LEO Pharma
  • Life Molecular Imaging GmbH
  • Mediscribe Consulting Ltd
  • Merus NV
  • Novo Nordisk A/S
  • Novo Nordisk A/S.
  • Novo Nordisk A/S. Company Member
  • Octapharma Pharmazeutika Produktionsges.m.b.H.
  • Oxford BioMedica
  • PRA Health Sciences
  • Takeda Pharmaceuticals International AG
  • Theravance Biopharma Ireland Limited
  • USGI Medical

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