Presented by
Management Forum
GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course
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 and update on the New ICH GCP R3 guideline.
★★★★★ "Very well done and would recommend to others"
3 July 2023
+ 24 November 2023
from £549
- Format: Live online
- 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 and update on the recently released ICH GCP R3. The programme will also examine inspection findings 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 requirements
- Be updated on the ICH including IC GCP R3 progress
- Clarify requirements for data integrity
- Technology advances in clinical trials
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.
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 from Go live
- Key changes
- Clinical Trials Information System (CTIS)
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 including
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
- 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 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
Laura Brown
LB Training and Development Ltd
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.
Book GCP and Clinical Research Update - Hot Inspection Topics Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
3 July 2023
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12208
- GBP 649
- EUR 929
- USD 1,049
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
24 November 2023
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 12334
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 20 Oct
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Reviews of IPI's GCP and Clinical Research Update - Hot Inspection Topics training course
Very well done and would recommend to others
Mar 10 2023
Jaclyn Verrow 
Director, TMF Compliance & Oversight, Vertex Pharmaceuticals
Mar 10 2022
Very good presentation and useful information with links, examples and clips which made it more interesting.
Kianoosh Khaksar 
Compliance Specialist, Lundbeck
Sep 24 2021
[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.
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.
United Kingdom
- EUSA Pharma
- Kyowa Kirin International plc
- Mediscribe Consulting Ltd
- Norgine
- Octapharma Pharmazeutika Produktionsges.m.b.H.
- Psychosis Research Unit
- University Hospitals Plymouth NHS Trust
- Vertex
- Zogenix Intermational Limited
Denmark
- Lundbeck
- Novo Nordisk A/S
United States of America
- MEI Pharma
- Vertex Pharmaceuticals
Belgium
- GlaskoSmithkline
France
- Institut De Recherches Internationales Servier Iris
Latvia
- JSC Olainfarm
Netherlands
- DADA Consultancy BV
Spain
- Ferrer
Sweden
- Hansa Medical AB
Switzerland
- CROSS Research S.A.
Run GCP and Clinical Research Update - Hot Inspection Topics Live online for your team
1 day
Typical duration
Pricing from:
- GBP 450
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
