GMP meets Regulatory Affairs

GMP meets Regulatory Affairs

Barcelona, Spain

Course No 15328


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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
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.

Target Group

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 -

What is a regulatory dossier?
Why do we need regulatory dossiers?
Why are regulatory dossiers binding?

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 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 3: How to document Drug Substance Quality - Certificate of Suitability (CEP) and Active Substance Master File (ASMF)
Documentation of drug substance quality in Module 2
The Quality Overall Summary (QOS)
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 procedures in US and Japan

CTD Module 4 and 5: nonclinical 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
Nonclinical summary
Critical points

The Quality Overall Summary (CTD Module 2) - Importance and Benefits
Regulatory background of QOS
Benefits (and why you can call it "Queen of Submission")
Frequent deficiencies, examples
Optimising the submission

Regulatory Compliance aspects during authority inspections
Types of inspections
Essential PQS interfaces
Change control from a GMP view
Deviations from Marketing Authorisations
Inspector's planning, preparation, conduction and follow-up of GMP inspections

Technical terms of GMP inspections - EU-GMP requirements
EU-GMP regulations
Technical terms of EU-GMP guidelines
Basic requirements for GMP inspections

Maintaining a Marketing Authorisation - The interaction between GMP and Regulatory Affairs -

Handling changes in the ICH countries
Starting a change in your company
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

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