Global Registration and Life Cycle Management of APIs - Live Online Training Contents of the regulatory information in the ASMF and CEP

Global Registration and Life Cycle Management of APIs - Live Online Training

Course No 20254

This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager". Learn more.

All times mentioned are CEST.

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Speakers

Marieke van Dalen, Aspen Oss B.V., The Netherlands
Cristina Jimenez Sala, Centrient Pharmaceuticals, Spain
Alma Kiso, European Directorate for the Quality of Medicines (EDQM & Health Care), France
Dr Wilhelm Schlumbohm, Berlin, Germany

Objectives

This Live Online Training 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 (R1)) and genotoxic impurities (ICH M7) will be considered. Furthermore, the impact of the variations regulations will be discussed.

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 Live Online Training 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 medicinal products and the API industry.

Technical Requirements

We use WebEx Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

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?

  • Overview of the procedures
  • Specifics for US and Japan

The EDQM Inspection Program

 

Three Case Studies
Stability Studies and Establishing the Retest Date
Cristian Jimenez Sala

Description of the Manufacturing Process
Dr Wilhelm Schlumbohm

Top ten Deficiencies in new Applications for Certificates of Suitability for Chemical Purity
Dr Alma Kiso

Important:
In order to prepare the lectures and the Case Studies in an optimal way, please send your questions to special topics prior to the Live Online Training to Ms Anne Günster, guenster@concept-heidelberg.de
She will forward your questions to the responsible speaker. Thank you in advance for your co-operation.

 

Registration Requirements for APIs in Emerging Countries

  • General remarks on API registrations in Emerging Countries
  • Details of API registration in:
    • Taiwan 
    • India 
    • CIS countries: Russia, Belarus, Ukraine 
    • 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

Regulatory Procedures in Brazil and China

  • Overview of the procedures
  • Specifics for Brazil and China
  • Experiences

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