PRE-CONFERENCE TRAINING COURSES, 25th and 26th April 2016


The following two pre-conference training courses will run in conjunction with the 2nd European QA Conference. The courses will run during the period Monday 25th April and Tuesday 26th April 2016:
  • Update & Refresher course in Clinical Research & GCP - one day course
  • Computerised System Validation (CSV): Risks, Requirements, Tests and Traceability - two day course
​Please note places are limited so please book early to avoid disappointment.

Update & Refresher course in Clinical Research & GCP - One day course 26th April 2016
This course will cover the following topics:
Impact of the revision to the ICH GCP guidelines E6 R2; an overview of the new EU clinical Trial Regulation No.2014/536; GCP Update and refresher - an interactive Q&A on GCP questions and problems; Consent in clinical trials - GCP requirements, individualising consent and testing knowledge; serious breaches - understanding the new reporting requirement with case studies.

Programme
09.00       Registration
09.30       Introduction to the course
09.45       Impact of the revision to the ICH GCP guidelines E6 R2
10.45       Break
11.20       Overview of the new EU Clinical Trial Regulation No. 2014/536
12.45       Lunch
13.45       Serious breaches - understanding the new reporting requirement with case studies
14.20       Consent in clinical trials - GCP requirements, individualising consent and testing knowledge
15.00       Break
15.20       GCP update and refresher - an interactive Q&A on GCP questions and problems
16.00       Round up and summary
16.15       Close

Course Fees
350 Euros up to 31st March 2016
450 Euros from 1st April 2016
Prices exclude French VAT which will be charged at the standard prevailing rate (currently 20%) if applicable.
Computerised System Validation (CSV): Risks, Requirements, Tests and Traceability - Two day course 25th & 26th April 2016
This course will provide delegates with an understanding of the computerised system validation process, including:
  • Strategies
  • Modelling and documentation
  • Risk management
  • Independent review
  • End-user requirements definition
  • Project Management and deliverables
  • Formal testing and qualification
  • Validation outputs
  • Maintaining compliance
  • Techniques to optimisation validation for efficiency and effectiveness
This course is for IS professionals implementing computerised ssystems; quality professionals monitoring or auditing systems; IS business partners and business system owners; End-users, testers and project staff.

Course Fees
Association members Euros 998.83
Non members Euros 1308.35
Prices exclude French VAT which will be charged at the standard prevailing rate (currently 20%) if applicable.
A 20% discount is offered for delegates who have booked a full delegate package at the conference
2nd European QA Conference hosted by SOFAQ, DGGF and RQA
Copyright -2016 European QA Conference