Investigators Meet Inspectors
EFGCP Workshop
Description
| 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.
Programme
| 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 |