Quality Management in Drug Development

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

Based on 392 participants

GMP & GDP training for pharma & biotech

Language:
2 days in total

€ 2495.00 ex. VAT

Registration ends in 320 days.

The upcoming start date of this training is guaranteed.

This training contains:

Lunch

Digital copy of materials

Training certificate

Certificate of competence

What you will learn

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.

Training Dates

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

Start date	End date	Dates	Language	Venue	Price	Register
Tuesday, May 19, 2026	Wednesday, May 20, 2026	5/19/26 to 5/20/26	English spoken language (primary)	Hotel Van Der Valk Breukelen	€ 2495.00	Register

Description

The Training

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.

Target Audience

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.

If you're a pharmacist or hospital pharmacist interested in earning accreditation points by attending this training,

(University) Students

Master students get a discount of 25% per module/training.

Results

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

Program

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: 10/28/25	3d	€ 2719.00
Quality Management in Biopharmaceutical Manufacturing	Next edition: 11/18/25	3d	€ 2719.00
Quality Management - the Role of the Qualified Person	Next edition: 3/24/26	5d	€ 3485.00
Quality Management in Drug Development (Current Module)	Next edition: 5/19/26	2d	€ 2495.00

Practical Information

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):: English spoken language (primary)

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:: Starts at approx. 08:30 and ends at approx. 17:30
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

Christine Mitchell

Trainer

Marel de Wit

Trainer

Reviews (34)

Based on 34 reviews

5 star reviews: 18%
4 star reviews: 59%
3 star reviews: 24%
2 star reviews: 0%
1 star reviews: 0%

5 out of 5 stars

Strong points (and why):

interactive

Anonymous - Anonymous

2025

5 out of 5 stars

Strong points (and why):

From basic understandings to more in detail topics

Review:

Cases are very good exercise

Anonymous - QA specialist

2025

4 out of 5 stars

Strong points (and why):

Variation in topicstarter, workshops

Anonymous - Anonymous

2025

5 out of 5 stars

Strong points (and why):

Good balance between lectures and workshops. Enough breaks

Anonymous - Qa intern/Msc student

2025

4 out of 5 stars

Strong points (and why):

The workshops

Anonymous - Anonymous

2025

5 out of 5 stars

Strong points (and why):

The case studies. The discussions with the group members and teachers.

Birke Geurts - RAQA Manager

2025

4 out of 5 stars

Strong points (and why):

The knowledge of the instructers and there was plenty of time for question and discussions.

Ger Molenaar - QP in training

2025

4 out of 5 stars

Strong points (and why):

Goede afwisseling tussen opdrachten en lectures

Review:

Probeer de opdrachten tussendoor iets meer te kaderen vanwege de korte tijd

Pol Vleer - QA Specialist

2025

5 out of 5 stars

Strong points (and why):

Good preparation

Anonymous - Sr QA Project Manager

2025

4 out of 5 stars

Strong points (and why):

Interaction and exercises

Review:

Regarding the exercises, clearer defined exercises and a bit more time would have been a plus

Xander - QA Manager

2024

4 out of 5 stars

Strong points (and why):

Training content covers all aspects of drug development

Review:

Trainers were well prepared for training and interactions was good. Training is helpful for my career growth.

Sunil Patil - QP, QA manager

2024

4 out of 5 stars

Strong points (and why):

The interaction with the trainers and other course members was very insightful.

Review:

Keep groups small. Trainers were very friendly, knowledgeable, and great in sharing their experience.

Mike Gielisse - Quality Specialist / QP

2024

Related Courses

€ 2495.00 ex. VAT

Registration ends in 320 days.

The upcoming start date of this training is guaranteed.

Difficulty:

Intermediate level Professional level