Quality Management in Drug Development

This two-day training provides insight into the regulatory requirements for drug development.

Based on 392 participants

Practical GMP & GDP training for pharma and biotech professionals — taught by senior PCS consultants who advise manufacturers on real GMP issues every week.

Language:
2 days in total

0 ex. VAT

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This training contains:

Accreditation for openbaar apothekers (KNMP), 12 Accreditation points

Accreditation for ziekenhuisapothekers (NVZA), 12 Accreditation points

Lunch

Digital copy of materials

Training certificate

Certificate of competence

What you will be able to do after this course

To be able to apply tools and strategies for the development and testing of a product.

A basic understanding of the clinical and non clinical studies to understand their impact on product development, the risks, and to manage and mitigate them in relation to product quality.

To be able to assess the right and relevant information about the product to be able to release it for its use in a non clinical or clinical study.

To enhance knowledge of regulatory requirements and best practices for the development of a pharmaceutical product and its quality to be able to comprehend the regulatory landscape.

To create an understanding of concepts and principles in pharmaceutical development to understand the risks, manage and mitigate them in the different stages of development.

Upcoming dates — pick a seat

Quality Course Modules default to English, but will be in Dutch if all attendees are Dutch or Flemish-speaking.

Start date	End date	Dates	Language	Venue	Price	Register
No open dates scheduled right now. Check back soon, or contact us to request a date or an in-house run for your team.

About this course

What this course covers

This training program is designed to equip professionals in the pharmaceutical industry and hospital pharmacies with the knowledge and skills necessary to effectively manage, assess and improve the quality of pharmaceutical products during pharmaceutical product development.

It focuses on the different stages in development and testing of a product in these phases to be able to determine the relevant issues and critical aspects of the production process and to compile and submit a registration dossier for market approval.

This course provides a comprehensive understanding of the pharmaceutical development and regulatory affairs landscape, the challenges during development and testing, the impact of gaining knowledge and implementing GMP and developing a pharmaceutical quality system during the different stages.

Participants will gain practical skills, regulatory knowledge, and ethical perspectives necessary to ensure product quality, patient safety, and compliance with industry standards (GLP/GCP/GMP/ICH).

It prepares professionals to excel in their roles and make meaningful contributions to the pharmaceutical industry and hospital pharmacies to be able to assess the relevant information in relation to new products for non-clinical studies and IMP’s for clinical studies.

What is it about?

This two-day training provides insight into the regulatory requirements for drug development from both the viewpoint of regulatory authorities as well as inspection bodies.

Following the journey of product development from drug discovery to non-clinical and clinical studies, the course touches upon the Registration Dossier and will discuss the GLP, GCP and GMP requirements and guidelines.

Understanding regulatory expectations will ensure professionals minimize delays and clarify the decisions made along the way.

Course structure

Expert knowledge and real-life case studies are combined to form an ideal learning experience. Professionals from industry and academia will share their wealth of experience and knowledge during the course. The course is highly interactive. The program is offered as a combination of self-study, theory, and practical case studies.

Who this course is for

The course is aimed at:

Professionals in the pharmaceutical and biotechnology industry;
Professionals in institutions and Contract Research and Manufacturing Organizations (CROs/CMO’s);
Hospital Pharmacists;
Post-graduate students.

This training is also suitable for openbaar apothekers and ziekenhuisapothekers, who will receive professional accreditation points.

(University) Students

Master's and PhD students get a discount of 25% per module/programme.

What you take back to work

After having followed this course, you will have:

Awareness of the difference between the GxPs and regulatory expectations.
Understanding of your role in the drug product development.
Knowledge on how to identify gaps in the data package to be submitted for regulatory approval.

Welcome, Introduction & Personal Expectations
Introduction to Drug Discovery - From Patient to Target Product Profile
The importance of GMP for IMP's and practical aspects including the role of the QP for IMP
- Workshop
The IMPD and the Registration Dossier
Defining the QTPP, CPP & CQA
QbD, ATP and Validation
Product Development
- Workshop
Pharmacokinetics & pharmacodynamics
GLP & Non-Clinical Studies
GCP & Clinical Trials
- Workshop
Workshop: Begin with the End in mind!
Reflection and closure

Programme

Lecture	Day
Welcome, Introduction and Personal Expectations	1
Introduction to Drug Discovery - From Patient to Target Product Profile (TPP)	1
The importance of GMP for IMP’s and practical aspects including the role of the QP for IMP Workshop	1
The IMPD and the Registration Dossier	1
Defining the QTTP, CPP and CQA	1
QbD, ATP and Validation	1
Product Development Workshop	1

Lecture	Day
Opening and Reflection	2
Pharmacokinetics and pharmacodynamics (PK/PD)	2
GLP & Non-Clinical Studies	2
GCP & Clinical Trials Workshop	2
Workshop: Begin with the End in mind!	2
Reflection, Evaluation & Closure	2

Quality Course modules

This module is part of a series called: "Quality Management in Pharma and Biotech". This series is designed to give participants an in-depth understanding of the QP’s role and responsibilities. See the other modules in this series below.

Module	Date	Length	Price
Quality Management in Sterile Manufacturing	Next edition: 27/10/26	3d	€ 2719.00
Quality Management in Biopharmaceutical Manufacturing	Next edition: 24/11/26	3d	€ 2719.00
Quality Management – The Role of the Qualified Person	No dates planned	5d	0
Quality Management in Drug Development (Current Module)	No dates planned	2d	0

Practical Information

Accreditation:: Openbaar Apothekers (KNMP), 12 Accreditation points

Ziekenhuisapothekers (NVZA), 12 Accreditation points
Difficulty / Level:: Intermediate level and Professional level
Group discounts:: 2 participants - 5%

3 participants - 10%

4 participants - 15%

4 participants - 20%

6+ participants - 25%

Group discounts are only applicable when multiple participants register for the same course at the same time.
Language (upcoming edition):: Some lectures/lessons may be in the secondary language. The primary language remains the dominant spoken/written language during the training.
Learning form:: Classroom
Times:: To be announced.
Requires preparation:: Yes.
This module contains homework. The homework will be provided prior to the training.
Includes exam:: Yes.
Exam price:: €350.00 ex. VAT per participant.
Notes to the course dinner:: The course dinner takes place on day 1.

Lecturers

Your trainers are practising PCS consultants. They spend most of their week helping pharma manufacturers respond to real GMP findings, audits and inspections — and bring that experience straight into the classroom.

Christine Mitchell

Docent

Christine Mitchell is a highly experienced Quality Assurance professional and consultant with ove...

Marel de Wit

Docent

Marel de Wit is an experienced Regulatory Affairs professional with over 10 years of expertise in...

Reviews (48)

Based on 48 reviews

5 star reviews: 21%
4 star reviews: 60%
3 star reviews: 19%
2 star reviews: 0%
1 star reviews: 0%

4 out of 5 stars

Strong points (and why):

The workshops were nicely designed to the lessons

Fercan - Student

2026

5 out of 5 stars

Strong points (and why):

The interactive sessions

Anonymous - Anonymous

2026

4 out of 5 stars

Strong points (and why):

The interaction

To be improved:

Iets eerder lunchen en niet langer dan een uur lang zitten/luisteren.

Shanna Waterlander - Apotheker kwaliteitsbeheer en qp

2026

3 out of 5 stars

Strong points (and why):

Enthusiasm of all people

To be improved:

Move info from module 1b to 2. Since toxic part for example fits better here. Too much info already provided. I would reorganize some stuff

Review:

Jolly good

Quinten - Qp in training

2026

4 out of 5 stars

Strong points (and why):

The trainers

Ton Hellemons - QA compliance

2026

4 out of 5 stars

Strong points (and why):

Interactive discussions, overview of differences between IMP and registered products, registration dossiers requirements

To be improved:

Some redundancy with module 1 in some slides

Marion Chomet - VP/QP in training

2026

4 out of 5 stars

Strong points (and why):

Real life cases and the experience of the training

To be improved:

The more technical subject PK/PD and QbD should have more examples and a more guided approach

Anonymous - Anonymous

2026

4 out of 5 stars

Strong points (and why):

Good basics and examples during the course

To be improved:

More specific on ATMPs. A lot of general aspects for 'generic' drug development are not of use for ATMPs, and other aspects are not really touched upon. For instance PK/PD

Suzanne - Projectleider ATMP

2026

4 out of 5 stars

Strong points (and why):

Workshops and pace of the training

Mireille - Manager QA

2026

5 out of 5 stars

Strong points (and why):

Good explanation of QbD, better understanding of CQA, CPP, good summary of PK/PD.

Review:

Goede cursus, ook als je wel aan productontwikkeling doet, maar niet persé registreert.

Tjitske Veenbaas - Hospital pharmacist

2026

5 out of 5 stars

Strong points (and why):

Interactieve sessies, delen van praktijkervaring

Tessa Ververs - Ziekenhuisapotheker

2026

4 out of 5 stars

Strong points (and why):

Workshops questions clearly answered in the end, also on slides.

To be improved:

Second day had no red/green or abcd questions I think, would be nice to have more of I think.

Emiel - Qp in opleiding

2026

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Difficulty:

Intermediate level Professional level