Sprecher
Dr Jörg Engelbergs, Paul- Ehrlich- Institut, Germany
Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany
Dr Claus-Dieter Schiller, . Hoffmann-La Roche AG, Switzerland
Zielsetzung
- 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
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
Technical Requirements
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Programm
- Regulatory Requirements
- Challenges
- Practical Hints
- Sources of Information
- Structure and Content
- Planning
- Preparation
- Submission
- Description of the manufacturing process, control of critical steps
- Manufacturing process development
- Characterisation and control of the active substance
- Control of excipients
- Specifications, batch analysis
- Stability data
- Substantial amendments
- Control of critical steps and intermediates
- Control of Impurities
- Analytical Procedures and validation requirements
- Justification of specifications and stability data
- Key aspects
- Practical examples
- 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
- This Case Study will focus on the essentials of clinical
- trials. The participants will get practical advice on how to successfully plan and prepare IMPDs.
- Changes that need to be notified
- Amendments that are to be regarded as “substantial”
- When have changes to be notified?
- Some examples
- Role of Investigators Brochure
- IMPD vs IND?
- Other countries e.g. Canada, Japan, China etc. – one dossier for all?
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This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager"
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