Global Registration and Life Cycle Management of APIs

Global Registration and Life Cycle Management of APIs

Barcelona, Spain

Course No 16336


Costs

Non-ECA Members: EUR 1790,--
ECA Members: EUR 1590,--
EU GMP Inspectorates: EUR 895,--
APIC Members: EUR 1690,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Marieke van Dalen, Aspen Oss, The Netherlands

Cristian Sampaolesi, European Directorate for the Quality of Medicines (EDQM & Health Care), France

Wilhelm Schlumbohm, Berlin, Germany

Jan Smeets, DSM Sinochem Pharmaceuticals, The Netherlands

Objectives

This education course is intended to provide guidance on the format, content and submission procedures for the pharmaceutical documentation of the quality of the drug substance for different types of dossiers, the CTD, the CEP and the European ASMF. In this context the consequences of the guidelines on Elemental Impurities (ICH Q3D) and genotoxic impurities (ICH M7) will be considered. Furthermore, the impact of the variations regulations will be discussed.

Participants will have the opportunity to choose 2 out of 3 parallel workshops:

  • Stability studies and establishing a retest date
  • Description of the manufacturing process
  • The CEP Procedure – do’s and don’ts

Background

In Europe there are several ways to document the quality of the drug substance for the purpose of marketing authorisation:
Certificate of Suitability of the pharmacopoeial monograph (CEP)
Full details of manufacture (according to CTD Module 3 Quality of Drug Substance)
European Active Substance Master File (ASMF; former Drug Master File, DMF)
Other evidence of suitability of the pharmacopoeial monograph

In the US, the quality of the drug substance can be documented as part of the CMC Dossier or in a US-DMF.

Target Group

The education course is designed for all persons involved in the compilation of pharmaceutical dossiers for marketing authorisations who want to become familiar with the different ways to document the quality of the drug substance for the purpose of marketing authorisation in Europe. Furthermore, the course will be of interest to personnel from Quality Units of the pharmaceutical and the API industry.

Programme

Dossier Requirements for the Drug Substance – An Introduction

  • Chemical pharmaceutical documentation for active substance(s) – Regulatory requirements in EU, 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
  • 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
Pharmaceutical Impurities: Residual solvents, synthesis-derived and genotoxic impurities
  • CPMP-/ICH-Guidelines on Impurities and Residual Solvents
  • ICH M7 Guideline on genotoxic 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?
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
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
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

Stability Studies and Establishing the Retest Date - Dr Jan Smeets

Description of the Manufacturing Process - Dr Wilhelm Schlumbohm

The CEP Procedure – do’s and don’ts - Cristian Sampaolesi

Important:
In order to prepare the lectures and the workshops in an optimal way, please send your questions to special topics to Dr Gerhard Becker, becker@concept-heidelberg.de

He will forward your questions to the responsible speaker. Thank you in advance for your cooperation.

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