Drug Master File Procedures in the EU, the US and Japan - Online Training Recording
Course No. 21975
Speakers
Dr. Wilhelm Schlumbohm
Marieke van Dalen
MARA Consultancy
Dr. Cornelia Nopitsch-Mai
formerly Quality Assessor
Objectives
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
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.
Target Group
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.
Technical Details:
To participate in an on demand training course or webinar, 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 or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe 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.
Programme
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
GDUFA question-based review: some US specifics
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
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
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.
The CEP 2.0: What is new?
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
Managing Changes in Drug Master Files - Case Studies
Recording from 17/18 September 2024
Duration of Recording: 8h 16min
This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager" Learn more
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