Global Registration and Life Cycle Management for APIs
8-10 April 2025, Vienna, Austria
Course No. 21631
Speakers
Dr. Wilhelm Schlumbohm
Cristina Jimenez Sala
Centrient Pharmaceuticals
Marieke van Dalen
MARA Consultancy
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.
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
This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager" Learn more
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