Drug Master File Procedures in the EU, the US and Japan
Im Auftrag der ECA Academy

29/30 September 2021

Berlin, Germany

Seminar Nr. 18345

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

Unser Seminarservice

Kosten

ECA-Member:	EUR 1590,--
Non ECA Member:	EUR 1790,--
EU/GMP Inspectorates:	EUR 895,--
APIC Member Discount:	EUR 1690,--

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
Hiltrud Horn, Horn Pharmaceutical Consulting, Germany
Usfeya A Muazzam, Bonn, Germany
Wilhelm Schlumbohm, Berlin, Germany

Zielsetzung

This education course is intended to provide guidance on the procedures for the European ASMF, the US-DMF and the Japanese DMF.

You will get to know

how to describe manufacturing processes
how to compile data for drug substance stability, impurities and residual solvents
which are the important points to consider for US-DMFs
which are the requirements for Japanese DMFs
how to handle changes in European, US- and Japanese DMFs
which are the major differences and advantages of the ASMF and CEP procedure

Participants will have the opportunity to join one of two parallel workshops about

Description of the manufacturing process
Managing changes in Drug Master Files

Hintergrund

Documentation of the drug substance quality is an integral part of any marketing authorisation application. In Europe the most common document for this purpose is the Active Substance Master File (ASMF) as long as the applicant has no Certificate of Suitability of the pharmacopoeial monograph (CEP). The European ASMF procedure differs significantly from the US-DMF procedure and for strategic reasons it is very important to take these differences into account. Moreover there are particular requirements for DMFs in Japan. For global acting companies it is a big challenge to handle the different procedures of compiling, submitting, changing and maintaining Drug Master Files in an efficient way.

Zielgruppe

The education course is designed for all persons involved in the compilation of pharmaceutical dossiers for marketing authorisations especially for Drug Master Files who want to become familiar with the different DMF procedures. Furthermore, the course will be of interest to personnel from Quality Units of the pharmaceutical and the API industry.

Parallel Workshops

Please choose one out of two parallel workshops

Description of the Active Substance manufacturing process
Managing changes in Drug Master Files – Case Studies

Programm

The European Active Substance Master File Procedure – An Introduction

Regulatory background and Scope
The revised ASMF guideline
Open and closed parts – points to consider
Comparison of ASMF and CEP procedure

Drug Master File Procedures in the US

Types of Drug Master Files
Drug Master Files under GDUFA
Submissions of DMFs
Holder obligations
Maintenance of Drug Master Files
US vs EU DMF – differences in the procedure

How to Document Drug Substance Stability

Stability Guidelines
Stability Testing of new drug substances and drug products
Storage Conditions
Bracketing and Matrixing Designs
Stability data from new drug dosage forms
How to document evaluation of stability data
Optimising the submission

Residual Solvents and Impurities: Synthesis Derived Impurities, Metals and Genotoxic Impurities

Guidelines
Impact of the new guidelines ICH Q3D and ICH M7
Sources of Impurities
Setting and justification of specifications
Residual solvents, solvent classes
Content and scope of data – documentation requirements
Frequent mistakes

Post Approval Changes in the US

Post approval activities
Reporting requirements to the FDA (CBE 0, CBE 30, Annual Report)
Post approval commitments and post approval reporting requirements
Risk evaluation and mitigation strategies (REMS)

Handling Changes in European Drug Master Files

Why is there a need for changes
Types of changes
How to communicate with the MA holders and how to get feed back
Differences between ASMF and CEP
When to implement a specific change
Version management of the ASMF

Requirements of the Drug Master File Procedure in Japan

Regulatory procedures in Japan:
- Site accreditation
- GMP paper based inspection
- Drug Master File
Drug Master File format
Specific points to consider for the J-DMF
Communication with the Japanese authorities

Changes and Maintenance of Japanese Drug Master Files

Change procedures and communication with the Japanese authority
Types of changes
Notification of changes

Comparison of the CEP and ASMF Procedure

The certification scheme of the Ph.Eur.
Advantages and disadvantages of the CEP procedure compared to the ASMF procedure
Handling of variations in the CEP procedure

Countries accepting CEPs

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Drug Master File Procedures in the EU, the US and JapanIm Auftrag der ECA Academy