Qualified Person IMP Pre-Course Session

Qualified Person IMP Pre-Course Session

Hamburg, Germany

Course No 20168

 

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Speakers

Dr Susanne Ding Boehringer Ingelheim, Germany
Patryk Jegorow, Takeda, Ireland
Sue Mann Sue Mann Consultancy, U.K.

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 take into account 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.

Presentations / Certificate / Hygiene Measures

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.

On site, we will implement the necessary and required hygiene measures in close co-operation with the hotel. If infection rates and/or travel restrictions generally do not permit an on site event, it will be conducted live online. In this case, you will be informed in due time.

Programme

General Introduction
  • Different clinical phases I to IV, focus on patient safety
  • Undefined processes (manufacture, fit for purpose control strategy, etc.)
  • Why use risk assessments & how to apply – vital core of a IMP quality system
  • Diversity: IMP manufacturers, start-ups, academia…
Specific Legal Requirements for IMPs
  • Clinical Trial Regulation EU No. 536/2014 and the “old” Annex 13 and Directives 2001/20/EC and 2003/94/C
  • The “new” ATMP Regulation
GMP meets Clinical Trials – Differences between IMPs and Commercial Products
  • Packaging & labeling
  • Randomization
  • Blinding / placebos
  • Comparators
  • NIMPs / AMPs
  • Where to apply validation activities
  • The Product Specification File (PSF)
  • 3rd country manufacture of IMPs: import and the QP Declaration
Registration
  • IMPD, CTA, IND etc.
  • Regulatory compliance and the two step release procedure
GMP/ GDP/ GCP Interface
  • Interaction with clinical sites
  • Distribution
  • IRT

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