Insights from an Auditor: Be 'GCP Inspection-Ready' - 21 September 2018

Who should attend?

This course offers a thorough update of the current understanding and interpretation of Good Clinical Practice and practical guidance/advice on how to ensure readiness for Health Authority inspections, both of Sponsor and Investigator sites.

It is designed for those with experience in clinical research requiring information on how to prepare for GCP inspections and for those seeking to update their knowledge on the changes to the ICH-GCP Guideline E6 R2. It is aimed at Clinical Research Assistants/Coordinators, Clinical Trial/Project Managers, Clinical Research Physicians, Study Data Managers, Monitors, those working in Clinical Quality and Compliance, and will also be of interest to those in related functions (Clinical Science, Drug Supply, Drug Safety, Regulatory).

Course Objectives

With this course you will:

• Refresh knowledge of ICH-GCP, particularly from the Sponsor perspective including the changes to ICH-GCP E6 R2
• Become familiar and discuss current "hot topics" in the Clinical Development environment
• Learn practical steps in preparing for Sponsor and Investigator site inspections
• Participate in interactive workshop exercises to improve course retention

Topics

• Overview of the history of GCP and the implementation of ICH-GCP
• Review of key elements of ICH-GCP, particularly related to Investigator / Sponsor responsibilities
• Changes to the ICH-GCP E6 R2 Guideline
• Impact of these changes on the conduct of Clinical Trials
• Inspection-Readiness: how to prepare for Sponsor / Site inspections
• Current "hot topics" in the area of Clinical Research, including: e-source documents, remote and risk-based monitoring

Course Leader

Ms. Alison E. Roberts has been involved in ICH-GCP, Clinical Research and Clinical Quality Assurance training for almost twenty years. She gained a BSc in Pharmacology from the University of Bath (UK) and has worked in the pharmaceutical industry since 1979, initially in Clinical Research operations and since 1991, in Clinical Quality Assurance. For the past fifteen years she has been working as an independent a Clinical Quality Assurance Auditor, Trainer and Consultant.

Learning Methodology

Interactive sessions with a mix of lecture, workshop exercises and Q&A.

Date:

21 September 2018

Time:

08.30 – 17.00 hrs

Venue:

CTC office
Münchensteinerstrasse 41
CH-4052 Basel

Directions:

Tram 15,
tram stop «Grosspeterstrasse»

Fee:

Early Bird Fee: CHF 855.00 + 7.7% VAT* (valid until: 10.08.2018)
Regular Fee: CHF 1'110.00 + 7.7% VAT* (valid after: 10.08.2018)
10 % reduction for CTC employees and SwAPP members

Registration fees include: Course documentation, refreshments, lunch and a course participation certificate.
Payment: After registration you will receive confirmation and an invoice with instructions on how to complete the bank transfer. Full prepayment is needed prior to the course.

Cancellation Policy:

• Cancellations received more than 14 days before course: 100% refund less bank charges & cancellation fee of CHF 50.00
• Cancellations received 7-14 days before the course: 50% refund
• Cancellations received 7 days before the course: no refund
In case of no show, no refund will be made

Document:

Insights from an Auditor_Flyer.pdf

Training Terms & Conditions