Investigators Meet Inspectors

EFGCP Workshop


Event Workshop
Type Face To Face
Language English
Date(s) 18 Jun. 2018
Day(s) 1 Day(s)
Duration 6 hours

Investigators have to comply with GCP guidance and national clinical trial legislation while integrating clinical trial activities into their routine care environment. This is an increasing challenge, and inspectors often see only the compliance aspects of this integration. The interpretation and application of guidance and legislation are not always clear to investigators.

EFGCP will provide you with an opportunity to directly ask inspectors all the questions you always wanted to ask. And inspectors will have an opportunity to understand more about the constraints and motivations of investigators performing clinical trials in their clinical settings.

Disclaimer: Please, note that the views and opinions expressed during this Open Forum are those of the speakers and do not necessarily reflect the official policies of their organisations. 


Monday 18 June 2018
10:00 Welcome & Introduction
Ingrid Klingmann, EFGCP / Pharmaplex, Belgium
Key Note Presentations
10:05 What is new for investigators in ICH-GCP(R2)
Petcharat Jones, Pfizer, UK
10:35 Q&A
10:45 GCP & Investigators: An Inspector's Perspective
Paula Walker, MHRA, UK
Discussion Forum: Morning Session
11:15 Your questions on best implementation practice of the new ICH-GCP(R2)
Dominique Delforge, GCP Inspector AFMPS/FAGG, Belgium
Ingrid Klingmann, EFGCP /Pharmaplex, Belgium
12:00 Lunch
Discussion Forums: Afternoon Session
13:30 Your questions on investigator delegation and oversight
Bruno François, CHU Limoges, France
Christine de Balincourt, EORTC, Belgium
14:00 Your questions concerning expected documentation practices including source data
Christine de Balincourt, EORTC, Belgium
14:30 Your questions concerning expected electronic data handling and data protection regulation
Gunnar Danielsson, DGD Consulting, former GCP inspector MPA, Sweden
Lisbeth Tofte Hemmingsen, Drug Safety Consult, Denmark
15:00 Your questions concerning preparing for inspection on both sides
Helen Cadiou, UCL / EFGCP, United Kingdom
Paul Strickland, Strickland Quality Assurance / EFGCP, United Kingdom
15:30 Your questions concerning classification of findings and responses to CAPAs
Beat Widler, Widler & Schiemann AG, Switzerland
Louise Mawer, Mirabilitas / RQA, United Kingdom
15:55 Conclusions and next steps
16:00 End of the Open Forum