Global Registration and Life Cycle Management for APIs

8-10 April 2025, Vienna, Austria

Course No. 21631

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

Participants will have the opportunity to take part in 3 Workshops:
  •  Stability studies and establishing a retest date
  •  Description of the manufacturing process
  •  Top ten deficiencies in new applications for Certificates of Suitability for chemical purity

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 medicinal products and the API industry.

Presentations / Certificate

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.

After the event, you will automatically receive your certificate of participation.

Programme

Global Registration and Life Cycle Management for APIs

Seminar Programme as PDF

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
  • CEP for a substance for TSE risk assessment

Requirements for the Certificate of Suitability to the European Pharmacopoeia

  • CEP Procedure: legal framework,  the role, place and scope
  • How the CEP procedure works for new CEPs
  • Basic principles for maintaining the CEP: administrative, minor and major changes, renewal of CEPs
  • Key figures and how to communicate with EDQM

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 / Implementation of CEP 2.0
  • How to interpret information laid down on CEP-practical examples
  • Project CEP 2.0: What has changed and what are the benefits?
  • CEP holders’ responsibilities towards their customers
  • How to use a CEP in marketing authorization application

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 Programme
  • How does the EDQM inspection procedure work
  • EDQM GMP Assessment tools: On-site inspections, documentation-based GMP Assessment and Real Time Remote Inspections (RTEMIS)
  • Inspection facts and figures


Stability Studies and Establishing the Retest Date
Cristina Jimenez Sala

Description of the Manufacturing Process
Dr Wilhelm Schlumbohm

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

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.

Country specific Requirements
  • 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
Regulatory Procedures in Brazil and China
  • Overview of the procedures
  • Specifics for Brazil and China
  • Experiences

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

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

ECA-Member*: € 2090,-
Non ECA Member*: € 2290,-
EU/GMP Inspectorates*: € 1145,-
APIC Member Discount*: € 2190,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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