A discount of EUR 400 applies when booking the QP Education Course Module A together with the IMP pre-course session.
Highlights:
- Legal Background - Tasks and responsibilities - Liability and indemnification
Target Group
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.
Objectives
Dear Colleagues,
The European Qualified Person Association (EQPA) has developed two Education Course Modules for new, trainee and practising Qualified Persons to address general compulsory and regulatory issues. This Module A has been compiled by the EQPA Board of Directors to provide a general idea of the special tasks and responsibilities of a QP, but also to discuss and convey possible solutions to problems addressed in case studies and workshops. How to master the QP role in practice including interfaces and interactions is a central topic of Module B. Broaden and intensify your knowledge of the Qualified Person’s duties and responsibilities. Experts from the EQPA Board of Directors, pharmaceutical industry and regulatory authority will share their experience on important issues of the QP’s daily business and will give first-hand information on current and future expectations.
Further impacts of the latest developments, specific tasks and further discussions will be part of the annual QP Forum of the European Qualified Person Association.
Best regards, Ulrich Kissel, Chairman of the European Qualified Person Association
Moderator Wolfgang Schmitt, on behalf of EQPA
Programme
This pre-course session provides a detailed overview of the specific characteristics in IMP manufacturing a QP must know to certify IMP batches for the release for clinical Trials.
Principles of Clinical Trials
Introduction to Clinical Trials
Principles involved in: - API and excipients - Bulk manufacturing - Packing and labelling - QP Certification and batch release
Final Thoughts for the QP
Specific Legal Requirements for IMPs
Definitions
Clinical Trial Regulation 536/2014
Clinical Trial Directive 2001/20/EC
MD Regulation 2017/745
IMP Guidelines (various)
Content of phase appropriate QMS overview
GMP meets Clinical Trials – Differences between IMPs and Commercial Products
Starting materials – Active pharmaceutical ingredient, excipient, diluent / reconstitution media
Bulk
Placebo
Comparator
Auxiliary Medicinal Product AxMP
Trial design, randomization
Order
Blinding principles
Packaging Scenarios
Labelling
Exemptions from the manufacturing authorization for packaging & labelling
Future concepts
IMP Batch Confirmation, QP Certification and IMP Release
Definitions / Regulations / Guidelines
IMP Release Process
Distribution Concept / Controlled Shipment of IMPs
GMP/ GDP/ GCP Interface
Reconstitution
Pre-requisites for randomisation and blinding
Distribution
Stability and shelf-life extensions
Trial Master File
Site to site transfers
Complaints and recall
End of study
Where does QP responsibility end?
Further Information
Date
Tuesday, 09 March 2027, 09:00–17:45 h (Registration and coffee 08:30–09:00 h)
Venue Barceló Sants Hotel Plaça dels Països Catalans, s/n 08014 Barcelona, Spain +34 (93) 503 53 00 sants@barcelo.com
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on-site and that there will not be any opportunity to print the presentations on-site. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Fees (per delegate plus VAT)
QP Association Members EUR 1,090 ECA Members EUR 1,090 Non-ECA/Non-QP Association Members EUR 1,290 EU GMP Inspectorates EUR 645
Save money when booking both events. A discount of EUR 400 applies when booking the QP Education Course Module together with the IMP pre-course session. The conference fee is payable in advance after receipt of invoice and includes lunch on all conference days and all refreshments. VAT is reclaimable.
Testimonials
