Qualified Person Education Course Module A & IMP Pre-Course Session
Understand the Implications of becoming a QP
9-11 March 2027, Barcelona, Spain
Course No. 22775
With an optional pre-course Session: Investigational Medicinal Products (IMP) QP Education Course on 09 March 2027 (A discount of EUR 400 applies when booking both training courses together.)
Highlights:
- Legal Background - Tasks and responsibilities - Liability and indemnification
Target Group
New and future Qualified Persons
QPs who are looking for ongoing training
Personnel who want to get a detailed overview of the role and responsibilities of a QP
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
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)
Concept of phase appropriate QMS oversight
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
The Legal and Professional Duties of the Qualified Person
The EU legislation and regulation Framework
Requirements for becoming a QP
Role and duties of a QP
Update on European Requirements
EU GMP Guide Chapters
EU GMP Guide Annexes
Other important News
What the QP needs to be aware of
Delegation of Duties and Responsibilities
Duties and responsibilities of a QP (summary)
Delegation of duties and responsibilities - Annex 16 - Importation - Assessments by others
Workshop on Case Studies: QP Discretion and Batch Certification
Batch certification: degrees of freedom and limits
Batch deviations and QP Certification: To certify or not, that’s the question
What the QP needs to know about Pharmacopoeias
The world of different Pharmacopoeias
Pharmacopoeias are more than just Monographs
How to deal with different methods
The role of QC and QA in Release (Presentation and Workshop)
Basic, common, and advanced release concepts including QC and QA
Reflections on OOS/OOT
Case studies
Discussion of possible solutions
What the QP needs to know regarding the Supply Chain (from Supplier Qualification to GDP)
Introduction to Supply Chains and expectations
QP´s role in supplier qualification and auditing
Written confirmation and QP Declaration
GMP meets GDP: where does the responsibility end?
QP’s involvement in the recall process
QP’s role in drug shortages
How the QP fits into the Quality Systems
How much involvement is needed in systems like: - Product Quality Review - Inspection Management - Batch Record Review - CAPA - Change Control - Validation - Complaints and recalls
Liability and Indemnification
Liability and indemnification of QPs
Responsibility in the pharmaceutical industry
Types of drug-related product liability claims
Advanced tips - trends in liability
Examples (interactive part)
Workshop: Deviations during the Manufacture of an API – What Actions should you take as the responsible QP?
Further Information
Venue for both Events 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.
Social Event On 10 March, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
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)
Pre-course Session: IMP QP Education Course QP Association Members EUR 1,090 ECA Members EURO 1,090 Non-ECA/Non-QP Association Members EUR 1,290 EU GMP Inspectorates EUR 645
QP Education Course QP Association Members EUR 1,890 ECA Members EUR 1,890 Non-ECA/Non-QP Association Members EUR 2,090 EU GMP Inspectorates EUR 1,045
Save money when booking both events. A discount of EUR 400 applies when booking both training Courses together. The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on all conference days and all refreshments. VAT is reclaimable.
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