Quality - Drug Substance and Drug Product

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

Download Material
  • TBD

3 days course

English

20.195,- DKK ex VAT
(app. 2.715,- EUR ex VAT)

Home > Courses > Quality - Drug Substance and Drug Product
At the moment there are no available dates for this course.

Module 6

Summary

This online 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 year.

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.

Course fee includes examination. By default you will pay the full amount to the University of Copenhagen regardless of you taking the exam or not. If you decide not to take the exam, you can apply for a refund of the exam fee at Atrium by contacting Atrium - please see contact details below. You must apply for a refund no later than two weeks after completion of the course.


Terms and conditions for signing up to and cancelling courses offered in collaboration between Atrium and the University of Copenhagen

  • These conditions apply to courses in Regulatory Affairs held in collaboration between Atrium and the University of Copenhagen.
  • These conditions apply as long as the campaign offering 2 participants for the price of 1 is valid, i.e. through May 31, 2020.
  • Enrolment to the University of Copenhagen via the course application form
  • The promotional offer 2 for 1 is obtained when two people from the same company register individually for the course and send an email to master@sund.ku.dk stating who you are participating with.
  • If one of the two participants cancels course participation, the full participation fee is still due, since the discount depends on two persons having signed up.
  • If one of the two participants cancels course participation, it is not possible for another employee from the company to take that place on the course within the discount scheme.
  • It is a condition that the debtor on the two payments is the same.
  • Master students' discount of DKK 2,000 waives if the promotional ”2 for 1” offer is used.

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

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.

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.

Show allShow fewer Faqs

This course is a part of this programme

Master of Medicines Regulatory Affairs (MRA)

University of Copenhagen in collaboration with Atrium ... Read more

Regulatory Affairs Diploma

Theoretical and practical aspects ... Read more

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

Send an email

 

You may also be interested in these courses