Referent:innen
Marieke van Dalen
MARA Consultancy, The Netherlands
Dr. Cornelia Nopitsch-Mai
formerly Quality Assessor
All times mentioned are CEST.
Zielsetzung
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
Hintergrund
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
Technical Requirements
Programm
Gesamtes Programm als PDF herunterladen
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Change procedures and communication with the Japanese authority
- Types of changes
- Notification of changes
- 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
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This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager"
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