Drug Master File Procedures in the EU, the US and Japan - Live Online Training
17/18 September 2024
Course No. 21212
Speakers
Dr. Wilhelm Schlumbohm
Marieke van Dalen
MARA Consultancy, The Netherlands
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.
Testimonials
Seminar Programme as PDF