Quality - Drug Substance and Drug Product

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

2. Feb 2022

3 days course

English

20,700 DKK ex VAT
(app. 2,783 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 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 

Hi! Do you need help choosing the right course?

We are ready to help you at +45 39 27 60 60 or contact@atriumcph.com

    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.

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    IS THIS COURSE FOR YOU?

    Whether you are new to the field or have several years of experience, this course is relevant if you are a Regulatory Affairs Professional who wants to improve your knowledge and skills.

    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

    Course calendar

    Starting 2. Feb 2022
    2. Feb 2022 9:00-16:00

    DAY 1

    • Introduction
    • Development of drug substance and drug product in the overall development programme
    • The ICH vision - Q8, Q9, Q10, Q11 and Q12
    • Drug substance synthesis
    • Drug substance characterisation
    • Preformulation
    • Workshop
    3. Feb 2022 9:00-16:00

    DAY 2

    • Short summary of day 1 and introduction to day 2
    • Drug product
    • Control of drug substance and drug product
    • Impurities - With a 15 minutes break included
    • Developing specifications: Drug substance and drug product
    • Workshop
    4. Feb 2022 9:00-16:00

    DAY 3

    • Short summary of day 1 - 2 and introduction to day 3
    • Pharmacopoeias
    • Container closure systems
    • Stability, drug substance and drug product
    • The certification scheme of the european pharmacopoeia (CEP)
    • The quality overall summary
    • Rounding off and good-bye
    Practical information

    Registration

    Registration deadline
    5. Jan 2022
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register (2 - 4 Feb)
    Sometimes things change. This is the expected programme.

    Course information

    Literature

    Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

    Please familiarize yourself with the mandatory readings before starting the course.

    The mandatory readings are also part of the examination syllabus.

    Prerequisites

    To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in regulatory affairs, or other equivalent qualifications. We consider all applications upon registration.

    If you do not fulfill the requirements, you can still apply for the course if you have experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 20% of the positions on our course are filled by applicants who have no or limited experience in regulatory affairs. We consider applicants on a case-by-case basis.

    Examination

    The exam is usually held 4-6 weeks after the course. It is a digital exam in the University of Copenhagen’s digital exam system.

    You can therefore take the exam in your own country.

    Please let us know if this is relevant for you as we can conduct exams at embassies, universities and so on worldwide.

    This course is a part of this programme

    Master of Medicines Regulatory Affairs (MRA)

    Are you a regulatory affairs professional and are you concerned with your ongoing learning and development consider these courses, offered in development with University of Copenhagen. Explore the Master of Medicines Regulatory Affairs (MRA)

    Read more
    Regulatory Affairs Diploma

    The regulatory affairs diploma gives you an understanding of the entire ‘regulatory affairs platform’ of the medicinal product lifecycle. All courses have been designed in collaboration with highly acclaimed experts, that are on our regulatory affairs faculty board

    Read more

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    WANT TO KNOW MORE or need help?

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

    Send me a message