Global registration and Life Cycle Management for APIs
Im Auftrag der ECA Academy

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.