Referent:innen

Dr. Wilhelm Schlumbohm

Dr. Wilhelm Schlumbohm

Marieke van Dalen

Marieke van Dalen

MARA Consultancy

Dr. Cornelia Nopitsch-Mai

Dr. Cornelia Nopitsch-Mai

formerly Quality Assessor

All times mentioned are CEST.

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
  •  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

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.

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.

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.

Programm

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

Gesamtes Programm als PDF herunterladen

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

ECA-Member*: € 1690,-
Non ECA Member*: € 1890,-
EU/GMP Inspectorates*: € 945,-
APIC Member Discount*: € 1790,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

icon
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
icon
Weitere Termine online
Weitere Termine online nicht verfügbar
icon
Aufzeichnung nicht verfügbar

Haben Sie noch Fragen?

Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.

Frau mit Headset
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de

Zurück

Teilnehmerstimmen - das sagen andere über unsere Seminare:

"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen.
Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.”
Christian Wagener, WAGENER & CO. GmbH
GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024

„Danke für das tolle und interessante Seminar! Ich nehme mir fachlich total viel mit und habe viele tolle Menschen kennengelernt.“
Melanie Schifferer, DAIICHI SANKYO EUROPE GmbH
Batch Record Review (QS 23)
September 2024

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023

„Interessante Themen, gut vorgetragen, die eigenen Erfahrungen der Vortragenden helfen, dies noch besser nachzuvollziehen.“ „Gute Gestaltung der Workshops, das Zusammenarbeiten in Gruppen und der Austausch mit anderen hilft sehr.“
Manuela Seibert, Merck, GMP-Leadauditor/in (FA 2), April 2024

NEWSLETTER

Bleiben Sie informiert mit dem GMP Newsletter von Concept Heidelberg!

GMP Newsletter

Concept Heidelberg bietet verschieden GMP Newsletter die Sie auf Ihren Bedarf hin zusammenstellen können.

Hier können Sie sich kostenfrei registrieren.

Kontakt

Kontaktieren Sie uns

Haben Sie Fragen?

Concept Heidelberg GmbH
Rischerstraße 8
69123 Heidelberg

Tel. :+49622184440
Fax : +49 6221 84 44 84
E-Mail: info@concept-heidelberg.de

zum Kontaktformular