Quality - Drug Substance and Drug Product

Get an overview of the quality-related requirements of the quality part of the dossier

  • 15. Nov 2017

3 days course

English

17.350,- DKK ex VAT
(app. 2.333,- EUR ex VAT)

Module 6

Summary

This module will provide you with a comprehensive overview of the quality-related requirements and critical issues of the quality part of the dossier with interfaces to product development and post-approval maintenance. You will learn about various subjects ranging from chemical synthesis of active substances and development of drug products to global quality trends. You will get an understanding of the CTD Module 3 and Quality Overall Summary Module 2, critical issues during development and in the submission stage, and how to compile the dossier with a view to future product maintenance.

You will receive lectures from international lecturers with extensive experience and expertise within chemical, pharmaceutical and analytical Development.

The course is offered every 2 years.

Keywords

Development of Drug Substance and Drug Product
The ICH Vision
CMC Documentation
Container Closure Systems
Control of Drug Substance and Drug Product
Pharmacopoeia
Impurities
Certificate of the European Pharmacopoeia (CEP)
The Quality Overall Summary
Global Quality Dossier
   

PLEASE NOTE:

As this module is a mandatory module in the Master of Medicines Regulatory Affairs at the University of Copenhagen, you will apply via the joint Atrium and University of Copenhagen application form. This means that you will be enrolled at both Atrium and the University of Copenhagen, and that your data will be registered at both institutions. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.

What you will learn


  1. To understand the basic principles of how to design, develop and document drug substances and drug products
  2. How data is generated, and how the work with drug substances and drug products is regulated by guidelines and standards
  3. How to analyze and evaluate development processes, reports, specifications, methods and data from a regulatory point of view in order to ensure coherency and transparency of the quality dossier and other regulatory documentation

What your company will get

  1. A regulatory affairs professional who understands the principles of the quality part of the dossier
  2. A regulatory affairs professional who is able to analyze and evaluate the development processes, reports, specifications, methods and data from a regulatory point of view
  3. A regulatory affairs professional who is able to challenge and ask the right questions with respect to the quality-related documentation
Available start dates
15. Nov 2017 (Registration deadline 15. Oct 2017)

Registration quick facts for master modules

When you click the “register”-button you will get to the joint Atrium and University of Copenhagen application form. To apply for the course you must fill out the form and send in the relevant documentation. If your application is accepted you will be enrolled both at Atrium and at the University of Copenhagen and your data will be registered at both institutions.

All modules that are mandatory in the Master of Medicines Regulatory Affairs at the University of Copenhagen are paid by invoice sent from the University of Copenhagen. See the University of Copenhagen’s terms and conditions here.

All the master modules can be taken individually. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Senior Programme Director Tina Jensen at +45 39 15 09 14

Send an email

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