GMP meets Regulatory Affairs Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective

GMP meets Regulatory Affairs

Barcelona, Spain

Course No 21622

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



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

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Marieke van Dalen, MARA Consultancy, The Netherlands
Dr Rainer Gnibl,  EU-GMP Inspector, Bavarian Government, Germany
Dr Josef Hofer, EXDRA, Germany
Dr Cornelia Nopitsch-Mai, Bonn, Germany


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.

Presentations / Certificate

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.

After the event, you will automatically receive your certificate of participation.


Getting Drugs Approved – What you need to know from a GMP Perspective

What is a Regulatory Dossier? - Setting the Scene for the Training
  • Reasons for filing regulatory dossiers
  • GMP aspects in regulatory dossiers
  • Compliance of the regulatory dossier
Drug Approvals in the ICH Countries: Prerequisites and Procedures
  • Centralized procedure
  • Decentralized procedure
  • Mutual recognition
  • National procedures
  • Specific dossier requirements for different medicinal products
  • Timelines
  • 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
  • Labelling
  • Package leaflet
  • Mock ups and specimen
  • Quality experts, non-clinical and clinical experts
  • Bibliographical applications
  • Homeopathic applications
  • Pediatric applications
CTD Module 3 – How to Document Drug Substance Quality around the World
  • How to provide CMC Information
  • What information is required in Module 3.2.S
  • Differences in interpretation of the requirements
  • Differences in format
  • Procedures in the various regions: US, EU, Japan, Brazil, China
CTD Module 3 – Quality of the Drug Product: Relevant GMP Documents
  • Medicinal product – documentation of quality in Module 3
    - Impurities
    - Stability data
    - Container and closure systems
    - Critical Parameters
  • Optimising the submission
  • Risk-based approach in industry and regulatory authority
CTD Modules 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
  • Toxicology
  • Pharmacokinetics
  • Safety studies – decision tree
  • Toxicity studies to qualify impurities
  • Non-clinical summary
  • Critical points
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
Other GMP Basics with MA & Regulatory Affairs Relevance
  • Required authorizations, registrations, certificates and how to get them
  • How to certify/release a batch?
  • Which audits are on duty?
Maintaining a Marketing Authorisation – The Interaction between GMP and Regulatory Affairs

Handling Variations and Changes
  • Why do we need to file changes
  • Handling changes within an API Company
  • Impact of a change: categorization of changes
  • Change procedures around the world: EU (ASMF and CEP), US, Japan, Brazil, China

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