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

29 Mar 2019

& 24 Sep 2019

GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 18 Feb

Book now

Course overview

Clinical research is a constantly evolving field and the regulatory requirements are regularly 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, data integrity and the impact of GDPR on clinical trials. 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) – overview and update including new supporting documents

  • Review of the key changes including the new clinical trial application process
  • Update on the additional guidance and directives
  • Compliance considerations for serious breaches

ICH GCP E6 R2 – practical examples of implementation to comply with 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 and document for CRO oversight and investigator oversight

  • How to demonstrate oversight of the investigator and expanded responsibilities under ICH GCP R2
  • How to meet inspectors’ expectations for sponsor oversight of CROs and other vendors

Risk management – new requirements for GCP compliance

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

Data integrity

  • The latest requirements and new regulatory guidance from MHRA, FDA, EU
  • Computer System Validation
  • Avoiding data integrity breaches
  • The TMF Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials (2017)

GDPR (General Data Protection Regulation) requirements for clinical trials

  • Penalties for non-compliance and reporting serious data breaches
  • Overview of key requirements including informed consent, contracts with suppliers, responsibilities of data controllers and data processors
  • Preparation of data protection impact assessments for clinical trials

Q & A and other hot topics

  • Brief overview of other recent GCP developments including electronic informed consent

Summary, action plans and final Q & A

Book now

29 Mar 2019
29 Mar 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
GBP 599.00
EUR 839.00
USD 934.00
Until 18 Feb
Enrol now
24 Sep 2019
24 Sep 2019 Cavendish 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
  • Hansa Medical AB
  • Octapharma Pharmazeutika Produktionsges.m.b.H.
  • Zogenix Intermational Limited

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.