Why do we Need an IMPD? Legal Framework and Regulatory Requirements
- Regulatory Requirements
- Challenges
- Practical Hints
- Sources of Information
General Requirements to an IMPD
- Structure and Content
- Planning
- Preparation
- Submission
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 – Description of the Manufacturing Process
- Control of critical steps and intermediates
- Control of Impurities
- Analytical Procedures and validation requirements
- Justification of specifications and stability data
Writing of the Drug Product Section of an IMPD
- Key aspects
- Practical examples
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
Case Study: Planning of an IMPD
- This workshop will Focus on the essentials of clinical trials. The participants will get practical advice on how to successfully plan and prepare IMPDs.
How to Manage and Document Changes to IMP 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
Quality Information Required for Global Clinical Trials
- Role of Investigators Brochure
- IMPD vs IND?
- Other countries e.g. Canada, Japan, China etc. – one dossier for all?