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

25-27 March 2025, Vienna, Austria

Course No. 21517

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Speakers

Dr. Sue Mann

Dr. Sue Mann

Sue Mann Consultancy

Dr Susanne Ding

Dr Susanne Ding

Boehringer Ingelheim Pharma

Dr. Julia Gudd

Dr. Julia Gudd

Behörde für Justiz und Verbraucherschutz (BJV)

Patryk Jegorow

Patryk Jegorow

Takeda

Dr Ulrich Kissel

Dr Ulrich Kissel

European QP Association (EQPA), KisselPharmaConsulting

Savvas Koulouridas

Savvas Koulouridas

Fagron BV

Aidan Madden

Aidan Madden

FivePharma

Dr Lance Smallshaw

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.

Programme

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

Seminar Programme as PDF

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
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?

ECA-Member*: € 2190,-
Non ECA Member*: € 2490,-
EU/GMP Inspectorates*: € 1245,-
QP Member Discount*: € 2190,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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