Presented by
Management Forum

GCP and Clinical Research Update - Hot Inspection Topics

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 + 2 more dates

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  • Format: Live online, Classroom
  • CPD: 6 hours for your records
  • Certificate of completion

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.

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The GCP and Clinical Research Update - Hot Inspection Topics course will cover:

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

  • 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

MHRA

  • Brexit and running clinical trials in the UK

FDA

  • 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

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Laura Brown

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.

More details

Book GCP and Clinical Research Update - Hot Inspection Topics Live online/Classroom training

10 Mar 2022

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11585

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 03 Feb

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16 Jun 2022

Classroom
London venue TBC

00:00-00:00 UK (London)
Course code 11379

  • GBP 599 699
  • EUR 839 979
  • USD 934 1,090

Until 12 May

  • 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

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22 Sep 2022

Live online

00:00-00:00 UK (London) (UTC+01)
01:00-01:00 Paris (UTC+02)
19:00-19:00 New York (UTC-04)
Course code 11700

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 18 Aug

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Reviews of IPI's GCP and Clinical Research Update - Hot Inspection Topics training course


[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.

Sep 24 2021

Angelo Jacala
Director, Clinical QA, MEI Pharma

Mar 29 2019

Very good and worthwhile attending.

Christopher Rollinson
Research Governance Manager, University Hospitals Plymouth NHS Trust

Sep 25 2018

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.

UK

  • EUSA Pharma
  • Mediscribe Consulting Ltd
  • Norgine
  • Octapharma Pharmazeutika Produktionsges.m.b.H.
  • Psychosis Research Unit
  • University Hospitals Plymouth NHS Trust
  • Vertex
  • Zogenix Intermational Limited

Belgium

  • GlaskoSmithkline

Denmark

  • Novo Nordisk A/S

France

  • Institut De Recherches Internationales Servier Iris

Netherlands

  • DADA Consultancy BV

Sweden

  • Hansa Medical AB

Switzerland

  • CROSS Research S.A.

United States of America

  • MEI Pharma

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy