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GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course

This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments

10 Mar 2022

& 16 Jun 2022 , 22 Sep 2022

Book now


Course overview

Clinical research is a constantly evolving field and the regulatory requirements are frequently being updated. In order to stay ahead and maintain your GCP knowledge, it is important to receive regular training.

This must-attend course provides a review of recent changes to relevant legislation and guidance and will look at how these developments have been implemented. Topics covered will include the latest update of the EU Clinical Trial Regulation, the final EMA TMF guideline and the further renovation of ICH GCP R2. The programme will also examine inspection findings and common failings in these new areas and how these should be addressed.

This is a highly interactive course suitable for those who need to refresh their knowledge and to demonstrate recent and up-to-date training to regulatory inspectors.

Benefits of attending:

  • Discuss recent developments in GCP and clinical trial legislation and guidance in the EU, UK and FDA considerations including Covid 19 for future studies
  • Review the requirements of the TMF
  • Identify common audit and inspection findings to help prepare for inspection
  • Understand the EU Clinical Trial Regulation implementation
  • Be updated on the ICH including ICH GCP R3 renovation
  • Clarify requirements for data integrity
  • Technology advances and GCP

Who should attend

The course is of particular relevance for those working in clinical research, regulatory affairs and pharmacovigilance, QA, Audit, CROs, academic trialists and regulatory inspectors. It will also be of interest to those departments who liaise/support clinical trial personnel and all other professionals who want to know more about updates in GCP regulations and guidelines covering clinical trials.


Brief review of regulatory authority inspections findings

Hot inspection topics, including EMA, MHRA and FDA findings

EU Clinical Trial Regulation (536/2014) update

  • Electronic EU clinical trial authorisation and the new CTIS
  • Update on implementation
  • Review of the key changes

Requirements of the EMA TMF from EMA GCP Inspectors Working Group

  • TMF structure, content, security, control, managing correspondence and emails, scanning and certified copies, maintaining the TMF and storage, e-TMFs, archiving and retention
  • The TMF plan – recommended format for compliance

Data Integrity guidance

  • What inspectors look for in this
  • MHRA integrity guidance

ICH update

  • New European Commission Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs)
  • ICH E8
  • ICH GCP E6 R3 update

Awareness update from other EU, MHRA and FDA


  • EU Guidance on trials during Covid - pandemic-proof’ studies moving forward
  • EMA guidance on validation & qualification of computerised systems
  • ENpr-EMA Guideline: Assent / Informed Consent Guidance for Paediatric Clinical Trials


  • Brexit and running clinical trials in the UK


  • Guidance for Industry, Investigators, and Institutional Review Boards: FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic
  • FDA methods to obtain informed consent during Covid
  • FDA Guidance on Enhancing the Diversity of clinical trial populations

Digitalisation and technology advances and GCP

  • Technology innovations and drug development
  • Electronic informed consent
  • Apps, medical devices and mobile technologies in clinical trials
  • Artificial intelligence
  • Virtual clinical trials

Conclusion and final Q&A


Laura Brown (More...)

Dr Laura Brown is an independent QA and training consultant and director of the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura has many years’ experience of managing GCP inspections in the pharmaceutical industry and has 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. She is an international expert on GCP and clinical trial requirements and was chair of the Institute of Clinical Research GCP Forum for six years. Laura writes regularly on clinical research regulatory requirements and has written a chapter in International Pharmaceutical Product Registration and several articles on the EU Clinical Trial Regulation, Brexit, and ICH GCP R2.

Book now

Book now

10 Mar 2022
Live webinar
10 Mar 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 3 Feb 22*
Enrol now
to attend
Live webinar
16 Jun 2022
Face-to-face, (venue not yet confirmed)
16 Jun 2022
(venue not yet confirmed)
GBP 699 599
EUR 979 839
USD 1,090 934
Until 12 May 22*
Enrol now
to attend
(venue not yet confirmed)
  • 1 day 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
22 Sep 2022
Live webinar
22 Sep 2022
Live webinar
GBP 599 499
EUR 859 719
USD 970 814
Until 18 Aug 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 6 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

Previous customers include...

  • CROSS Research SA
  • DADA Consultancy BV
  • EUSA Pharma
  • GlaskoSmithkline
  • Hansa Medical AB
  • Institut De Recherches Internationales Servier Iris
  • Mediscribe Consulting Ltd
  • MEI Pharma
  • Norgine
  • Novo Nordisk A/S
  • Octapharma Pharmazeutika Produktionsges.m.b.H.
  • University Hospitals Plymouth NHS Trust
  • Vertex
  • Zogenix Intermational Limited

[Laura] is a good presenter, she has world of knowledge. She was also able to get open discussion with the participant which made the course more interesting.

Angelo Jacala, Director, Clinical QA, MEI Pharma, Sep 21

Very good and worthwhile attending.

Christopher Rollinson, Research Governance Manager, University Hospitals Plymouth NHS Trust, Mar 19

It was understandable and fullfiled my expectations. I received many useful links and publications, which I can search for. The content was good but a bit too much information in a short timeslot.

Ines Kovacikova, Lead CRA, Octapharma Pharmazeutika Produktionsges.m.b.H., Sep 18