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

23-25 March 2021

Berlin, Germany

Seminar Nr. 17965

Unser Seminarservice

Kosten

ECA-Member:	EUR 1790,--
Non ECA Member:	EUR 1990,--
EU/GMP Inspectorates:	EUR 995,--
APIC Member Discount:	EUR 1890,--

Alle Preise zzgl. MwSt.

Zur Anmeldung

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Marieke van Dalen, Aspen Oss B.V., The Netherlands
Marta Miquel, European Directorate for the Quality of Medicines (EDQM & Health Care), France
Dr Wilhelm Schlumbohm, Berlin, Germany
Dr Jan Smeets, Centrient Pharmaceuticals, The Netherlands

Zielsetzung

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 join 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

Hintergrund

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.

Zielgruppe

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.

Programm

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

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

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.

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Global registration and Life Cycle Management of APIsIm Auftrag der ECA Academy