Quality - Drug Substance and Drug Product, module 6

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

10 - 12 Oct 2023

or

7 - 9 Oct 2024

On location

English

21,730 DKK ex VAT

(app. 2,922 EUR ex VAT)

Summary

Module 6

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.


Other course participants say

"It's an excellent course for someone needing an overview of 32S and 32P with deep dives into some of the topics. The workshops were the best thing about the course because they gave rise to good discussions."

Jeff Møller, Regulatory Affairs Specialist, Pharmacosmos


    Hi! 

    Do you need help choosing the right course? 

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    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.


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    Course leader & lecturers

    • Karen Fich
      Course leader
      Director, Head of RA-CMC
      H. LUNDBECK A/S
    • Inger Mollerup
      Course leader
      Independent Regulatory Consultant
      Inger Mollerup Regulatory Consulting
    • Peter Hudson
      Lecturer
      Phd, Senior Director, Head of PMO
      Hovione
    • Christine Weber
      Lecturer
      Scientific Senior Consultant
      Emendo a/s
    • Siham Barghadouch
      Lecturer
      Project Manager, Primary Packaging R&D, Devices & Delivery Solutions
      Novo Nordisk A/S
    • Michala de Neergaard
      Lecturer
      Late Stage Analytical Development, Manager
      ALK-ABELLÓ NORDIC A/S
    • Suzanne Wigchert
      Lecturer
      Associate Director Regulatory Strategy Benelux
      Vertex Pharmaceuticals
    • Rikke Pedersen
      Lecturer
      Senior Regulatory Affair Professional
      Novo Nordisk A/S
    • Anne-Sofie Thøger Andersen
      Lecturer
      Regulatory Specialist, Product Lead
      Novo Nordisk A/S
    • Maria Fullerton
      Lecturer
      CMC operational lead, Regulatory Specialist
      H. LUNDBECK A/S
    • Tine Kock Thorslund
      Lecturer
      Senior Global Regulatory Affairs Manager, Technical Writing
      Ferring Pharmaceuticals A/S
    See all

    Is this course for you?

    This course is for you if you work as a regulatory affairs specialist, employed in the industry, a regulatory agency, or a consulting firm.

    You must have a minimum of 2 years relevant job experience.

    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

    Choose your starting date
    Starting 10 Oct 2023
    Starting 7 Oct 2024
    10 Oct 2023 8:30-18:30

    Day 1

    • Light breakfast and network
    • Introduction, overall process, and expectations
    • Development of drug substance and drug product in the overall development programme
    • The ICH vision – Q8, Q9, Q10, Q11 and Q12
    • Workshop
    • Drug substance synthesis
    • Drug substance characterization
    • Preformulation
    • Kahoot
    • Workshop
    • Networking with tapas
    11 Oct 2023 8:15-16:30

    Day 2

    • Light breakfast and network
    • Short summary of day 1 and introduction to day 2
    • Drug product
    • Impurities
    • Control of drug substance and drug product and developing specifications: Drug substance and drug product
    • Workshop
    12 Oct 2023 8:15-16:30

    Day 3

    • Light breakfast and network
    • Short summary of day 2 and introduction to day 3
    • Container closure systems
    • Stability, drug substance and drug product
    • The quality overall summary
    • Accelerated development & workshop
    • Life cycle management
    • Rounding off
    • End of course
    Practical information

    Registration

    Registration deadline
    29 Aug 2023
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    10 - 12 Oct
    7 Oct 2024 9:00-16:00

    Day 1

    • Light breakfast and network
    • Introduction, overall process, and expectations
    • Development of drug substance and drug product in the overall development programme
    • The ICH vision – Q8, Q9, Q10, Q11 and Q12
    • Workshop
    • Drug substance synthesis
    • Drug substance characterization
    • Preformulation
    • Kahoot
    • Workshop
    • Networking with tapas
    8 Oct 2024 9:00-16:00

    Day 2

    • Light breakfast and network
    • Short summary of day 1 and introduction to day 2
    • Drug product
    • Impurities
    • Control of drug substance and drug product and developing specifications: Drug substance and drug product
    • Workshop
    9 Oct 2024 9:00-16:00

    Day 3

    • Light breakfast and network
    • Short summary of day 2 and introduction to day 3
    • Container closure systems
    • Stability, drug substance and drug product
    • The quality overall summary
    • Accelerated development & workshop
    • Life cycle management
    • Rounding off
    • End of course
    Practical information

    Registration

    Registration deadline
    26 Aug 2024
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    7 - 9 Oct
    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.

    This course is a part of a diploma

    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 together with University of Copenhagen. Explore the Master of Medicines Regulatory Affairs (MRA).

    Read more
    Diploma in Regulatory Affairs

    The regulatory affairs diploma gives you an understanding of the entire regulatory affairs platform of the medicinal lifecycle. All courses have been designed in collaboration with highly acclaimed experts that are on our regulatory affairs Advisory Board.

    Read more

    Course leaders

    Karen Fich
    Director, Head of RA-CMC
    H. LUNDBECK A/S
    Inger Mollerup
    Independent Regulatory Consultant
    Inger Mollerup Regulatory Consulting

    Lecturers

    Peter Hudson
    Phd, Senior Director, Head of PMO
    Hovione
    Christine Weber
    Scientific Senior Consultant
    Emendo a/s
    Siham Barghadouch
    Project Manager, Primary Packaging R&D, Devices & Delivery Solutions
    Novo Nordisk A/S
    Michala de Neergaard
    Late Stage Analytical Development, Manager
    ALK-ABELLÓ NORDIC A/S
    Inger Mollerup
    Independent Regulatory Consultant
    Inger Mollerup Regulatory Consulting
    Suzanne Wigchert
    Associate Director Regulatory Strategy Benelux
    Vertex Pharmaceuticals
    Rikke Pedersen
    Senior Regulatory Affair Professional
    Novo Nordisk A/S
    Anne-Sofie Thøger Andersen
    Regulatory Specialist, Product Lead
    Novo Nordisk A/S
    Maria Fullerton
    CMC operational lead, Regulatory Specialist
    H. LUNDBECK A/S
    Tine Kock Thorslund
    Senior Global Regulatory Affairs Manager, Technical Writing
    Ferring Pharmaceuticals A/S

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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