GCP (Good Clinical Practice) and Clinical Research Update: Hot Inspection Topics Training Course (ONLINE EVENT)

Dublin, June 20, 2024 (GLOBE NEWSWIRE) -- The "GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course" conference has been added to ResearchAndMarkets.com's offering.

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 guidance and legislation and will look at how these developments have been implemented and are likely to be implemented. Topics covered will include the EU Clinical Trials Regulation and associated documents and an update on ICH GCP R3

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

  • Be updated on ICH GCP R3
  • Discuss recent developments in GCP and clinical trial legislation and guidance in the EU, FDA considerations
  • Review the requirements of clinical trail essential documentation
  • Identify common audit and inspection findings to help prepare for inspection
  • Understand the EU Clinical Trial Regulation requirements
  • Clarify requirements for data integrity and governance
  • Explore technology advances in clinical trials


  • CPD: 6 hours for your records
  • Certificate of completion

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.

Key Topics Covered:

Brief review of regulatory authority inspection findings

EMA, MHRA and FDA findings

New ICH GCP E6 R3 draft guideline

  • What is new and likely to impact on running trials
  • Revised principles
  • Data governance
  • Records and reports
  • Key updates, additions and revisions
  • ICH E8

Other ICH updates

  • European Commission Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs)
  • ICH E8

Data integrity governance

  • What inspectors look for
  • MHRA integrity guidance compliance
  • ICH GCP R3 Governance requirements

EU Clinical Trial Regulation (536/2014) update

  • Key changes and documentation
  • Update since go-live
  • Clinical Trials Information System (CTIS)
  • EU clinical trial authorisation
  • Serious Breaches

Essential records: EMA key requirements to avoid inspection findings, and documents requirement in ICH GCP E6 R3

  • TMF structure, content, security, control, maintaining the TMF and storage, e-TMFs, archiving and retention
  • ICH GCP R3 - recommended format for compliance

Awareness update from EU and FDA

  • EU
    • EMA Guidance on validation & qualification of computerised systems
    • European Commission Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs)
    • Artificial intelligence reflection guidance in lifecycle
    • Stronger enforcement of the GDPR in cross-border cases
  • Real-world data
  • FDA
    • Guidance for industry: considerations for the use of real-world data
    • FDA guidance on enhancing the diversity of clinical trials
    • A risk-based approach to monitoring of clinical investigations
    • Informed consent guidance for IRBs, clinical investigators and sponsors

Digitalisation and technology advances and GCP

  • Technology innovations in clinical research
  • Electronic informed consent
  • Apps, medical devices and mobile technologies in clinical trials
  • Artificial intelligence
  • Decentralised clinical trials

Conclusion and final Q&A


Laura Brown
Pharmaceutical QA and Training Consultant
University of Cardiff

Dr Laura Brown MBA, BSc,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 in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International.

She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including "The Planning of International Drug Development", in the Clinical Research Manual, Euromed and the "Impact of Brexit", RQA Journal 2017.

For more information about this conference visit https://www.researchandmarkets.com/r/ky5ajg

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