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

15 September 2020

Hamburg, Germany

Course No 18048

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Speakers

Susanne Ding, Boehringer Ingelheim, Germany
Sue Mann, Sue Mann Consultancy, U.K.
Brenda Van Assche, Janssen, Belgium

Objectives

This pre-course session provides a detailed overview of the 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.

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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