Dr Wilhelm Schlumbohm
Berlin
Referierende
Marieke van Dalen
MARA Consultancy
Dr Cornelia Nopitsch-Mai
formerly Quality Assessor
Zielgruppe
The Live Online Training 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.
Zielsetzung
This Live Online Training is intended to provide guidance on the procedures for the European ASMF, the US-DMF and the Japanese DMF.
You will get to know
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
Background
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.
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.
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
- The worksharing procedure for assessments of ASMFs
- Upcoming European developments: Potential implications of the pharma package
Drug Master File Procedures in the US
- How to file and use Drug Master Files in the US
- The format and the content of the US Drug Master File
- Specific points to consider for the US Drug Master File
- Question-based review: some US specifics
How to document Drug Substance Quality
- How to provide CMC Information
- CTD guidance: contents of the file
- Differences in interpretation
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
Description of the Active Substance Manufacturing Process
- Description of the manufacturing process
- Active substance starting material
- Critical steps in the Synthesis
- Process validation for active substances
- Case studies
Handling Changes in the US
- What guidance to use
- Types of changes in the US guidance and the procedures around it
- How to classify a change in the US
- Link to the FDA inspection program
Handling Changes in the EU
- 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
Comparison of the CEP and ASMF Procedure
- The certification scheme of the Ph.Eur.
- Handling of variations in the CEP procedure
- Advantages and disadvantages of the CEP procedure compared to the ASMF procedure
- When to use a CEP or an ASMF in an MAA
How to Document Drug Substance Stability
- Stability guidelines
- Stability testing of new drug substances and drug product
- Storage conditions
- Bracketing and matrixing designs
- Stability data from new drug dosage forms
- How to document evaluation of stability data
- Optimising the submission
Requirements of the Drug Master File Procedure and Change Control Procedure in Japan
- File procedure and change control 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
- Change procedures and communication with the Japanese authority
- Types of changes
- Notification of changes
Managing Changes in Drug Master Files – Case Studies
Weitere Informationen
Technical Details
To participate in an on demand training course, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration
When you register for the on demand training course, you can decide at what date you want to follow the training course online. Starting with the access date you entered in the registration process the stream will be available to you for 7 days. Within in this period you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Contacts:
Questions regarding content:
Dr Christian Arndt, +49 62 21 84 44-14, arndt@concept-heidelberg.de
Questions regarding organisation:
Mr Rouwen Schopka, +49 62 21 84 44-24, schopka@concept-heidelberg.de.
Recording from 6-7 October 2026
Duration Recording: 9h 06m
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Regular Fee*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager"
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E-Mail: info@concept-heidelberg.de
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