Qualified Person in Clinical Trials
Course Objectives
This course will cover the revised details of Annex 13 of the GMP guideline, published in January 2010. Do not miss this opportunity to get all your questions answered!
The role of the QP has remained fairly constant since 1975 however in May 2004, the EU Clinical Trials Directive becam mandatory and the role of the Qualified Person was modified to include the certification of IMPs. T
The 'CT QP' must be familiar with EU and national requirements and be able to work effectively with colleagues in the clinical trials arena to improve current systems. This interactive 2-day training will clarify the expectations facing QPs and ensure your company can meet the demands of the EU Clinical Trials Directive with confidence.
What Will You Learn?
- Revised details of Annex 13 of the GMP guideline read more
- QP compliance with the EU Clinical Trials Directive read more
- Determine the correct level of contribution to GCP. read more
- Changes and challenges facing the Qualified Person read more
- Where and how the QP will be involved read more
- Role of the Qualified Person with regard to IMPs read more
- Systems and procedures for your company read more
Course Highlights
- Interpret the EU Clinical Trials Directive and identify its impact on your future role
- Take practical steps to ensure GMP in the manufacture of IMPs
- Carry out compliant batch record review and release
- Fulfil your new duties with total confidence and meet your legal responsibilities
- Complying with Code of Practice to become a QP Grandfather
Dates and Venues
24 Jun 2010 - 25 Jun 2010
Regus Poultry, London, UK
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals
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