Dr Josef Hofer
exdra
Referent:innen
Marieke van Dalen
MARA Consultancy
Dr Wolfram Eisenreich
Boehringer Ingelheim Pharma
Sonja Estermann
F. Hoffmann-La Roche
Dr. Jörg Engelbergs
Paul-Ehrlich-Institut
All times mentioned are CEST.
Zielsetzung
This Live Online Training highlights the key principles of the Quality Part of an IMPD for Investigational Medicinal Products, both of chemical and biotechnological origin. You will get to know the essential aspects relevant for compiling the IMPD Quality Part and you will learn
- How to prepare and process the quality related information for drug substance and drug product
- How to manage and document changes concerning quality data
- How to consider quality parameters of drug substance and drug product with potential clinical relevance
- How to describe the manufacturing process development for a biotech IMP
- How to process and document stability data for an IMPD of a biotech product
Hintergrund
An IMPD is required for every Investigational Medicinal Product (IMP) to be used in a clinical study, regardless of whether it is the test product itself, a reference product already authorised or a placebo. The IMPD includes summaries of information related to the quality, manufacture and control of the IMP as well as data from non-clinical and clinical studies. Furthermore, it contains an overall risk-benefit assessment and critical analyses of the non-clinical and clinical data related to the potential risks and benefits of the proposed study.
In March 2006 the CHMP “Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning Investigational Medicinal Products in Clinical Trials” was published in Chapter III of Volume 10 of EudraLex.
Another CHMP Guidance for Biologicals entitled “Guideline on the Requirements for Quality Documentation concerning Biological Investigational Medicinal Products in Clinical Trials” was adopted in March 2012 and became effective in April 2012.
In March 2006 the CHMP “Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning Investigational Medicinal Products in Clinical Trials” was published in Chapter III of Volume 10 of EudraLex.
Another CHMP Guidance for Biologicals entitled “Guideline on the Requirements for Quality Documentation concerning Biological Investigational Medicinal Products in Clinical Trials” was adopted in March 2012 and became effective in April 2012.
Zielgruppe
This Live Online Training is designed for all persons involved in the compilation of IMPDs who want to become familiar with the requirements for the quality documentation of investigational medicinal products. The training will be of interest in particular for personnel from Regulatory Affairs as well as for personnel from Quality Assurance, Quality Control and Production.
Date & Technical Requirements
Tuesday, 27 May 2025, 09.00 – 16.30 h
Wednesday, 28 May 2025, 08.30 – 16.30 h
All times mentioned are CEST.
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Wednesday, 28 May 2025, 08.30 – 16.30 h
All times mentioned are CEST.
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Programm
Gesamtes Programm als PDF herunterladen
Clinical Trial and IMPD: Legal Framework and regulatory Environment
- Clinical Trial Authorisation Process following Regulation 536/2014/EU
- GMP requirements in clinical trial management
- Inspections on clinical trials e.g. GCP inspections
IMPD: Regulatory Requirements and Life Cycle Management
- IMPD and IB (Investigator’s Brochure) overlaps and differences
- Clinical Trials EU and International: Similarities and challenges
Quality Documentation for a Biotech IMPD – Manufacturing Process and analytical Characterisation
- Description of the manufacturing process, control of critical steps
- Manufacturing process development
- Characterisation and control of the active substance
Quality Documentation for a Biotech IMPD – Product Control and Stability Studies
- Control of excipients
- Specifications, batch Analysis
- Stability data
- Substantial amendments
Drug Substance Information
- Description of the manufacturing process
- Control of critical steps and intermediates
- Control of impurities
- Specifications and analytical methods
- Stability studies
IMP Dossier: Quality Drug Product
- Investigational medicinal product under test
- Chemical and pharmaceutical quality of:
- authorised, non-modified test
- modified authorised test
- concerning placebo products - Chemical and pharmaceutical quality of IMPs in bio-equivalence studies, novel excipients, solvents for reconstitution and diluents and auxiliary medicinal products
Quality Information of authorised modified and non-modified Comparator Products
- Description and composition
- Summary of Product Characteristics (SmPC)
- Additional information for Phase II and Phase III clinical Trials
- Quality information on existing active substances in bio-equivalence studies
- Quality information on placebo products
IMPD Planning and Organisation: Case Study
During this Case Study, we will explain and present how to plan and organise IMPDs. Take advantage of the experiences of our speakers and send us your questions and challenges prior to the Live Online Training.
IMPD Quality data – Changes, Modifications and Amendments
- Categorisation substantial / non-substantial modification
- Documentation and processing
- Strategies and Timing
How to handle Paediatric Formulations
- What is a Paediatric Investigation Plan (PIP)?
- Legal framework and content of the Quality Part
- Specific aspects for the formulation development (Taste, Preservatives, etc.)
- Specific aspects for a Paediatric Q-IMPD
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This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager"
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