Qualified Person IMP Pre-Course Session

25 March 2025, Vienna, Austria

Course No. 21516

header-image

Speakers

Dr Susanne Ding

Dr Susanne Ding

Boehringer Ingelheim Pharma

Patryk Jegorow

Patryk Jegorow

Takeda

Dr. Sue Mann

Dr. Sue Mann

Sue Mann Consultancy

Objectives

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.

Background

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.

Target Group

New colleagues becoming IMP QPs, QPs looking for continuous training and personnel of CROs and “non-commercial” IMP organisations.

Programme

Qualified Person IMP Pre-Course Session

Seminar Programme as PDF

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?

ECA-Member*: € 990,-
Regular Fee*: € 1190,-
EU/GMP Inspectorates*: € 595,-
QP Member Discount*: € 990,-

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

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

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

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023