Presented by
Management Forum
GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course
This course provides recent updates on the New ICH GCP R3 guideline, EU Clinical Trial Regulation update, other EU and FDA requirements, consideration for managing studies in the future and AI and other technology developments.
★★★★★ "Very well done and would recommend to others"
- 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:
- Be updated on the ICH including IC GCP R3 progress
- Discuss recent developments in GCP and clinical trial legislation and guidance in the EU, FDA and ICH 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
- 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
EMA, MHRA and FDA findings
New ICH GCP E6 R3 draft guideline
- What is new and likely to impact on running trials and inspection
- Revised principles
- Data governance
- Records and reports
- Important updates, additions and revisions
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
- Electronic EU clinical trial authorisation
- Update on implementation from go-live
- Key changes
- Clinical Trials Information System (CTIS)
- Interim Guidance Document on How to Approach the Protection of Personal Data and Commercially Confidential Information while using the Clinical Trials Information System (CTIS)
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
- 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
- New 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 and 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.
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
15 March 2024
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
05:30-13:00 New York (UTC-04)
Course code 14174
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 09 Feb
- 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
1 July 2024
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 14175
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 27 May
- 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
22 November 2024
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 14176
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 18 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
Belgium
- argenx
- GlaskoSmithkline
Denmark
- Lundbeck
- Novo Nordisk A/S
United States of America
- MEI Pharma
- Vertex Pharmaceuticals
France
- Institut De Recherches Internationales Servier Iris
Latvia
- JSC Olainfarm
Netherlands
- DADA Consultancy BV
Spain
- Ferrer International S.A.
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, based on 10 attendees
- 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:
