GMP meets Regulatory Affairs

(Im Auftrag der European Compliance Academy)

GMP meets Regulatory Affairs <p>(Im Auftrag der European Compliance Academy)

Prague, Czech Republic

Seminar Nr. 9241


Die Veranstaltung hat bereits stattgefunden

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Marieke van Dalen, Aspen Oss B.V., The Netherlands
Dr Josef Hofer, EXDRA GmbH, Germany
Dr Usfeya A Muazzam, Bonn, Germany
Dr Rainer Gnibl, EU-GMP Inspector, Bavarian Government


During this course you will get to know the relevant aspects of applying for and maintaining a marketing authorisation in the ICH countries. You will learn what you need to know from a GMP perspective about

the basic requirements for drug approval in Europe, the US and Japan
the structure of the marketing authorisation dossier according to the CTD
the input from the GMP regulated departments
drug approval procedures in the EU and US
documents to be provided and timelines to be observed
the peculiarities of drug approval procedures in Japan
how to handle changes and variations in the EU, the US and Japan


For getting a drug approved it is required to demonstrate its quality efficiency and safety. For that purpose the format of the Common Technical Document (CTD) which is mandatory in Europe since more than 10 years now has to be used. It is also used to apply for a marketing authorisation in the US and Japan.
Therefore a good understanding of the CTD structure is inevitable and a basic requirement for all persons from GMP regulated departments involved in providing and compiling documents for a marketing authorisation application.
For the maintenance of a marketing authorisation it is very important to know how to handle all the changes and variations occurring during the life cycle of a medicinal product.

The rules for handling variations in Europe are laid down in the variations regulation (EC) No. 1234/2008 – being applicable as well for national marketing authorisations from August 3rd 2013 – and supporting guidelines.

For handling changes in the US rules are provided in different guidances for industry and for approval of changes in Japan there are specific procedures in place to be followed. Maintaining marketing authorisations in a global scenario is a challenge and requires strategic planning and a good knowledge of the different regulations and timelines.

Efficient and smooth communication between GMP and Regulatory Affairs is a key factor of success.


This education course is designed for all persons involved in the compilation of pharmaceutical dossiers for global marketing authorisations in the EU and USA. Furthermore the course will be of interest to personnel from Regulatory Affairs, Quality Assurance, Quality Control and Production and Project Management.


Getting Drugs Approved – What you need to know from a GMP perspective
Drug Approvals in the ICH countries: prerequisites and procedures
Centralized procedure
Decentralized procedure
Mutual recognition
National procedures
Specific dossier requirements for different medicinal products
Time Lines
Generic applications
New Drug Application (NDA)
IND procedure and special issues
Abbreviated New Drug Application (ANDA) – Generics
Pre-approval inspections
Timelines and meetings with the FDA
Regulatory requirements in Japan
GMP regulations in Japan (J-GMP)

CTD Module 1:
Summary of product characteristics and other national requirements
Quality related aspects of the SmPC
- Clinical particulars
- Pharmacological properties
- Pharmaceutical particulars
Package leaflet
Mock ups and specimen
Quality experts, non-clinical and clinical experts
Bibliographical applications
Homeopathic applications
Paediatric application

CTD Module 2:
Quality of the Drug Substance: relevant GMP documents
Presentation and format of the dossier
Active Pharmaceutical Ingredient – documentation of quality in Module 2
ASMF procedure and CEP procedure
Stability data
The Quality Overall Summary (QOS)

CTD Module 3:
Quality of the Drug Product: relevant GMP documents
Medicinal product – documentation of quality in Module 3
Stability data
Container and closure systems
Critical parameters
Optimising the submission
Risk-based approach in industry and regulatory authority

CTD Module 4 and 5:
Non-clinical and clinical documentation: GMP, GCP and GLP aspects
Clinical study reports
Efficacy and safety
Clinical summary and clinical overview
Non-clinical study reports
Safety studies – decision tree
Toxicity studies to qualify impurities
Non-clinical summary
Critical points

How to document Drug Substance Quality: Certificate of Suitability (CEP) and Active Substance Master File (ASMF) in EU and DMF in US and Japan
CEP and ASMF procedure – how they work in principle
Types and format of ASMFs
Contents of the applicants part and the restricted part
How to apply for a CEP
Dossier Content
CEP assessment and CEP inspections
DMF in US and Japan

Peculiarities of drug approvals in Japan: GMP and quality-related aspects
Management of Japan-specific requirements in marketing authorisation
Establishment of regulatory documentation for and from Japan,
international challenges
Japanese oriented organisation and structures in drug regulatory affairs

Regulatory Compliance aspects during authority inspections
Different types of inspections
Inspections with respect to the marketing authorisation: Procedures,
key aspects, typical findings
What to do in the case of deviations from the dossier; Q.P. discretion

Maintaining a Marketing Authorisation – The interaction between GMP and Regulatory Affairs
Handling variations in the ICH countries
The variations procedure in Europe
General provisions of the Commission Regulation (EC) No 1234/2008
- Supporting guidelines
- Best practice guides and explanatory notes
- Classification of variations
- Procedural handling of variations; grouping, worksharing
Handling Changes in the US: Changes to an approved NDA and ANDA
Types of changes
Change control procedure and reporting mechanisms
Handling changes in Japan: Change procedures and communication with the Japanese authority
Types of changes
Notification of changes


GMP Seminare nach Thema

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