Qualified Person IMP Pre-Course Session

4 June 2024, Munich, Germany

Course No. 20899



Dr Susanne Ding

Dr Susanne Ding

Boehringer Ingelheim Pharma

Dr. Sue Mann

Dr. Sue Mann

Sue Mann Consultancy


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.


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.


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)
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?

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To find alternative dates for this training/webinar or similar events please see the complete list of all events.

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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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Testimonials about our courses and conferences

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

Anthony Cummins, Sebela Pharmaceuticals, Ireland
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“Good overview of different types of agreements, good to see both the GMP and the legal angle”

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“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