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 up to date and maintain your GCP knowledge, it is important to receive regular training.

This course provides an update on recent changes to relevant legislation and guidance and will discuss how these changes have been implemented. Topics covered will include ICH GCP R2, the EU Clinical Trial Regulation, the final EU TMF guideline and data integrity. The programme will discuss 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
  • Identify common audit and inspection findings and discuss how to prevent these occurring
  • Understand the impact on clinical trials of recent GCP principles and regulatory standards such as the EU Clinical Trial Regulation (536/2014) and GDPR (2016/679)
  • 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

New EU Clinical Trial Regulation (536/2014)

  • Review of the key changes
  • Update on implementation
  • Compliance considerations

ICH GCP E6 R2 – update and inspectors’ expectations

  • Update on the revision of ICH GCP R2
  • Practical implications of the key changes
  • Requirements for clinical QMS and QTLs (quality tolerance limits)
  • Hot topics discussion, including procedures for ‘certified copies’

Oversight – how to demonstrate CRO oversight and investigator oversight

  • Oversight of the investigator and expanded responsibilities under ICH GCP R2
  • Inspectors’ expectations for sponsor oversight of CROs and other vendors

Risk management – including new requirements

  • Quality risk management requirements
  • Risk-based monitoring
  • Examples of risk-based tools to demonstrate compliance

Final EU TMF guideline and data integrity

  • The latest requirements
  • EU TMF guideline on GCP compliance
  • Avoiding data integrity breaches

Q & A and other hot topics – brief overview of other recent GCP developments in the EU and US

  • Electronic informed consent
  • GDPR requirements for 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.