Qualified Person Education Course Module A PLUS IMP Pre-Course Session
25-27 March 2025, Vienna, Austria
Course No. 21517
Speakers
Dr. Sue Mann
Sue Mann Consultancy
Dr Susanne Ding
Boehringer Ingelheim Pharma
Dr. Julia Gudd
Behörde für Justiz und Verbraucherschutz (BJV)
Patryk Jegorow
Takeda
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Savvas Koulouridas
Fagron BV
Aidan Madden
FivePharma
Dr Lance Smallshaw
UCB Pharma
Objectives
IMP Pre-Course Session
This pre-course session provides a detailed overview of the basic and specific characteristics in IMP manufacturing a QP must know to certify IMP batches for the release for clinical trials.
Qualified Person Education Course
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.
Background
IMP Pre-Course Session
The manufacture of investigational medicinal products (IMPs), including labelling, packaging, testing and certification, is carried out in accordance with the applicable GMP regulations. However, this is not a routine process, since, among other things, manufacturing and packaging procedures might be different for each and every clinical trial. The Qualified Person (QP) must therefore consider these particularities and the GMP/GCP Interface.
Qualified Person Education Course
Over the last years the role and responsibilities of the Qualified Persons have been increasing considerably. As a key person in the company, the QP has to consider many issues and has to take up the challenges within its areas of responsibilities. Additionally, as laid out in Article 49 of the European Directive 2001/83/EC, the QP needs to be highly qualified and experienced. This education course is one important part to help the QP be on top of current developments in GMP and regulatory requirements.
Target Group
IMP Pre-Course Session
New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.
Qualified Person Education Course
New and future Qualified Persons, QPs who are looking for ongoing training and personnel who want to get a detailed overview of the role and responsibilities of a QP.
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?
Programme QP Education Course Module A
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
Summary
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
Workshop: What the QP needs to know about OOS/OOT
Involvement of the QP
Role and responsibility of the Head of Quality Control
Responsibility of the QP
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?
Testimonials
Seminar Programme as PDF