Speakers

Dr. Wilhelm Schlumbohm

Marieke van Dalen

MARA Consultancy

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

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

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

Seminar Programme as PDF

Programme 29 September 2020

09.00 – 09.15 h Introduction

09.15 – 10.00 h
The European Active Substance Master File

Procedure – An Introduction
Regulatory background and Scope
The revised ASMF guideline
Open and closed parts – points to consider
Comparison of ASMF and CEP procedure

10.00 – 10.15 h
Q & A Session

10.15 – 10.45 h Break

10.45 – 11.30 h
Drug Master File Procedures in the US

Types of Drug Master Files
Drug Master Files under GDUFA
Submissions of DMFs
Holder obligations
Maintenance of Drug Master Files
US vs EU DMF – differences in the procedure

11.30 – 11.45 h
Q & A Session

11.45 – 12.30 h
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

12.30 – 12.45 h
Q & A Session

12.45 – 14.00 h Break

14.00 – 14.45 h
Post Approval Changes in the US

Post approval activities
Reporting requirements to the FDA (CBE 0, CBE 30, Annual Report)
Post approval commitments and post approval reporting requirements
Risk evaluation and mitigation strategies (REMS)

14.45 – 15.00 h
Q & A Session

15.00 – 15.30 h Break

15.30 – 16.30 h
Description of the Active Substance Manufacturing Process

Regulatory basis - relevant guidelines
Description of the Active Substance Manufacturing process
Active substance starting material
Critical steps in the synthesis
Process validation

16.30 – 16.45 h
Q & A Session

Programme 30 September 2020

08.30 – 09.15 h
Comparison of the CEP and ASMF Procedure

The certification scheme of the Ph.Eur.
Advantages and disadvantages of the CEP procedure compared to the ASMF procedure
Handling of variations in the CEP procedure
Countries accepting CEPs

09.15 – 09.30 h
Q & A Session

09.30 – 10.15 h
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

10.15 – 10.30 h
Q & A Session

10.30 – 11.00 h Break

11.00 – 11.45 h
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

11.45 – 12.00 h
Q & A Session

12.00 – 13.00 h Break

13.00 – 14.15 h
Requirements of the Drug Master File Procedure in Japan (Part 1 and 2)

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

14.15 – 14.30 h
Q & A Session

14.30 – 15.00 h Break

15.00 – 16.00 h
Workshop
Managing Changes in Drug Master Files – Case Studies

16.00 – 16.30 h
Final Q & A Session

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

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

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