Speakers

Dr. Wilhelm Schlumbohm

Marieke van Dalen

MARA Consultancy

Dr. Cornelia Nopitsch-Mai

formerly Quality Assessor

All times mentioned are CEST.

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 Requirements

We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.

Programme

Drug Master File Procedures in the EU, the US and Japan - Live Online Training

Seminar Programme as PDF

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

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

ECA-Member*:	€ 1890,-
Non ECA Member*:	€ 2090,-
EU/GMP Inspectorates*:	€ 1045,-
APIC Member Discount*:	€ 1990,-

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

Further dates on-site

Further dates on-site
Not available

Further dates online

Further dates online
Not available

Recording Available

Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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