Qualified Person Education Course Module A PLUS IMP Pre-Course Session

Qualified Person Education Course Module A PLUS IMP Pre-Course Session is organized by Concept Heidelberg GmbH and will be held from Mar 25 - 27, 2025 at DoubleTree by Hilton Vienna Schonbrunn, Vienna, Wien, Austria.

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.

Programme Pre-Course Session: Investigational Medicinal Products (IMP) QP Education Course
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?

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

The role of QC and QA in Release (Presentation and Workshop)

• 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?