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GCP and Clinical Research Update - Hot Inspection Topics

This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented

27 Mar 2020

& 25 Sep 2020

GBP 699
EUR 979
USD 1,090

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 with an industry expert
  • Review the requirements of the new EMA TMF guidance
  • Identify common audit and inspection findings to help prepare for inspection
  • Understand the impact of the EU Clinical Trial Regulation and discuss the latest updates on clinical trial approvals and notifications
  • Be updated on the ICH GCP R2 renovation
  • Clarify requirements for clinical QMS and QTLs (quality tolerance limits)

Who should attend

The course is of particular relevance for those working in clinical research, regulatory affairs and pharmacovigilance. 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 EU portal
  • Update on implementation
  • Review of the key changes
  • New site templates which should have already been implemented
  • Serious breaches requirements
  • Compliance considerations and implementation checklist

Requirements of the new EMA TMF guideline from EMA GCP Inspectors Working Group

  • What are the most common areas for critical and major inspection findings?
  • TMF guidance published by EMA GCP Inspectors Working Group applicable from June 2019
  • Key recommendations in the guideline
  • 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
The EU Clinical Trial Regulation and General Data Protection Regulation Q&A guidance
  • European Commission and European Data Protection Board guidance on GDPR for clinical trials
  • GDPR requirements for clinical trials
  • Legitimate basis for processing clinical trial data
  • GDPR and transparency, consent requirements, data security, data risk assessment and procedures for data breaches
ICH update
  • New European Commission Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs) covering gene therapies, cell therapies and tissue-engineered products2
  • ICH GCP E6 R2 renovation
    • Update on the revision of ICH GCP R2
    • Practical implications of the key changes
    • Requirements for clinical QMS and QTLs
    • Quality by design
    • Oversight
    • Risk management approaches and tools
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

Summary, action plans and final Q & A


Laura Brown

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials

Book now

27 Mar 2020
27 Mar 2020 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
25 Sep 2020
25 Sep 2020 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • CROSS Research SA
  • EUSA Pharma
  • GlaskoSmithkline
  • Hansa Medical AB
  • Institut De Recherches Internationales Servier Iris
  • Octapharma Pharmazeutika Produktionsges.m.b.H.
  • University Hospitals Plymouth NHS Trust
  • Vertex
  • Zogenix Intermational Limited

Very good and worthwhile attending.

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

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.