Dr Wolfram Eisenreich, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
Dr Siegfried Giess, formerly Paul-Ehrlich-Institut, Germany
Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany
Dr Claus-Dieter Schiller, F. Hoffmann-La Roche AG, Switzerland
This education course 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
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.
This education course 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 course will be of interest in particular for personnel from Regulatory Affairs as well as for personnel from Quality Assurance, Quality Control and Production.
Why do we need an IMPD? - Legal Framework and Regulatory Requirements
General Requirements to an IMPD
- Regulatory Requirements
- Practical Hints
- Sources of Information
Quality Documentation for a Biotech IMPD – Manufacturing Process and Analytical Characterisation
- Structure and Content
Quality Documentation for a Biotech IMPD – Product Control and Stability Studies
- Description of the manufacturing process, control of critical steps
- Manufacturing process development
- Characterisation and control of the active substance
Drug Substance – Description of the Manufacturing Process
- Control of excipients
- Specifications, batch analysis
- Stability data
- Substantial amendments
Writing of the Drug Product Section of an IMPD
- Control of critical steps and intermediates
- Control of Impurities
- Analytical Procedures and validation requirements
- Justification of specifications and stability data
Quality Information of Authorised Modified and non-modified Comparator Products
- Key aspects
- Practical examples
How to Manage and Document Changes to IMP
- 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
Quality information required for global clinical trials
- Quality Data – Substantial Amendments
- Changes that need to be notified
- Amendments that are to be regarded as “substantial”
- When have changes to be notified?
- Some examples
Case Study: Planning of an IMPD
- Role of Investigators Brochure
- IMPD vs IND?
- Other countries e.g. Canada, Japan, China etc. – one dossier for all?
This workshop will focus on the essentials of clinical trials. The participants will get practical advice on how to successfully plan and prepare IMPDs.