Dossier Requirements for the Drug Substance – An Introduction
- Chemical pharmaceutical documentation for active substance(s) – Regulatory requirements in EU and USA
- Types of active substances – types of documentation
- CTD Module 3, CEP and ASMF (former DMF)
- CEP for a substance for TSE risk assessment
Requirements for the Certificate of Suitability to the European Pharmacopoeia
- Regulatory basis: Resolution AP-CSP (99)4 of the Council of Europe
- CEP Procedure
- Content of the CEP dossier with practical examples
- Administrative minor and major changes, 5-year’s revision
The European Active Substance Master File Procedure
- Regulatory background and scope
- The revised European ASMF guideline
- Applicant‘s and restricted parts - points to consider
- Questions & Answers on the ASMF procedure
- Recent European developments: Sharing of assessment reports, data bases ….
Pharmaceutical Impurities: Residual solvents, synthesis-derived and genotoxic and elemental impurities
- CPMP-/ICH-Guidelines on Impurities and Residual Solvents
- ICH M7 Guideline on genotoxic impurities
- ICH Q3D(R1) Guideline on elemental impurities
- Specifying Impurities
- Classifying solvents, setting and proving limits
- Justification of Specification
- Stability Data
- CPMP/ICH Guidelines
- Stability Summary and Conclusions, stability commitment
- Documentation of Stability Data
- Necessity for documentation of raw data?
How to read and use a CEP
API Regulatory Starting Materials: how to defend their choice in a submission
- Why is this such a hot topic
- What guidelines to consider
- How to define a suitable starting material
- How to defend your choice in the submission
- What is different for generics
- Consequences of a redefinition
Comparison of the CEP and DMF Procedure
- Advantages of the CEP procedure
- Handling Changes
- In which countries is the CEP being accepted?
- Cost Considerations
- Practical examples
Registration procedures in the US and Japan – what are the differences?
The EDQM inspection program
Registration requirements for APIs in emerging countries
- General remarks on API registrations in Emerging Countries
- Details of API registration in:
- China | Taiwan | India | CIS countries: Russia, Belarus, Ukraine | Brazil | GCC countries
- APIC Emerging Countries Interest Group
Variations/Changes and life cycle management: in the EU, US and rest of the world
- Types and categories of API changes
- EU: the variation regulation and CEP revisions
- Handling API changes in the US
- Handling API changes in Japan
- Handling API changes outside these regions
- Initiatives to facilitate changes.
ICH Q3D – how to do in practice for APIs
Stability Studies and Establishing the Retest Date - Dr Jan Smeets
Description of the Manufacturing Process - Dr Wilhelm Schlumbohm
Top ten deficiencies in new applications for Certificates of Suitability for chemical purity - Marta Miquel
Important:
In order to prepare the lectures and the workshops in an optimal way, please send your questions to special topics to Ms Anne Günster,
guenster@concept-heidelberg.de. She will forward your questions to the responsible speaker. Thank you in advance for your cooperation.