Quality - Drug Substance and Drug Product

This course provides the students with a comprehensive overview of the quality related requirements and critical issues of the quality part of a registration dossier of a medicinal product with interfaces to product development and post approval maintenance.

The various subjects range from chemical synthesis of active substances and development of medicinal products including Quality bu Design (QbD) to global quality trends. 

WHAT YOU WILL LEARN

This course will introduce you to regulatory quality requirements and documentation in regards to medicinal product development. You will be able to explain and identify the basic principles of regulatory quality requirements and documentation and learn how this work is regulated through guidelines and standards in order to obtain a market authorisation.

You will learn to apply and analyse the development processes, methods and data to ensure coherency and transparency of the quality dossier and compliance with required guidelines and quality standard. The course will teach you how to act in the chemistry, manufacturing and control (CMC) interface, and analyse and discuss the CMC documentation in relation to the clinical phases.

After the course, you will be able to make quality plans and take decisions with regard to pharmaceutical development. Lastly, you will learn to review and assess pharmaceutical data and documentation at all levels of the drug development and life cycle.

COURSE CONTENT

Attendees will get an understanding of the basic principles of how to design, develop and document active substances and medicinal products i.e. how data are generated and how the work is regulated by guidelines and quality standards. Additionally, the student should be capable of analyzing and evaluating the development processes, reports, specifications, methods and data – all seen from a regulatory point of view.

PARTICIPANTS

Participants must meet the following criteria: 
• A relevant bachelor degree or equivalent 
• A minimum of 2 years working experience within regulatory affairs 
• Be proficient in English

COURSE DETAILS

Course dates

3 days, 4-6 November 2019

Course fee

EU/EEA citizens Master student DKK 18,275

Non EU/EEA citizens Master student DKK 20,275

EU/EEA citizens Single course student DKK 20,275

Non EU/EEA citizens Single course student DKK 22,300

Application deadline

9 September 2019

Applications will be processed by receipt, and applicants are admitted on a "first come, first served" basis. Registration will close when the maximum number of seats are taken. Applicants will be notified of admission within 4 weeks of submitted application. 
Please note that the course can be cancel or rescheduled if the number of participants fails to meet the required minimum.

EXAMINATION

3 hours written assignment with descriptive questions and multiple choice held on Digital Exam - The online platform for examination at the University of Copenhagen.

Credit

4 ECTS

Examination date

To be announced.