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

€ 2280.00 ex. VAT

Registration ends in 259 days.

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, June 3, 2025	Wednesday, June 4, 2025	6/3/25 to 6/4/25	English spoken language (primary)	Hotel Van Der Valk Breukelen	€ 2280.00	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.

(University) Students

Master- and PhD-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
Pharmacokinetics & pharmacodynamics
The IMPD and the Registration Dossier
Getting to know the IMPD and the Registration Dossier - Where to find what information
Product Development for the Purpose of Non-Clinical and Clinical Studies
Product Development (TPP, CPP & CQA)
Analytical Development
Product & Analytical Development
Introduction GLP & Non-Clinical Studies
Non-Clinical Studies
Introduction GCP & Clinical Studies
GCP & Clinical Studies
Theory of GMP for IMP’s and its practical aspects including the role of the QP for IMP
From development documentation to IMPD to registration filing including changes, deviations and their impact on the registration dossier
Reflection and closure

Program

Lecture	Day
Welcome, Introduction and Personal Expectations	1
Introduction to Drug Discovery - From Patient to Target Product Profile (TPP)	1
Pharmacokinetics and pharmacodynamics (PK/PD)	1
The IMPD and the Registration Dossier	1
Getting to know the IMPD and the Registration Dossier - Where to find what information	1
Product Development for the Purpose of Non-Clinical and Clinical Studies	1
Product Development (TPP, CPP & CQA)	1
Analytical Development	1
Product & Analytical Development	1

Lecture	Day
Opening and Reflection	2
Introduction GLP & Non-Clinical Studies	2
Non-Clinical Studies	2
Introduction GCP & Clinical Studies	2
GCP & Clinical Studies	2
Theory of GMP for IMP’s and its practical aspects including the role of the QP for IMP	2
From development documentation to IMPD to registration filing Changes Deviations and their impact on the regulatory dossier	2
Reflection and 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: 11/5/24	3d	€ 2590.00
Quality Management in Biopharmaceutical Manufacturing	Next edition: 11/26/24	3d	€ 2590.00
Quality Management - the Role of the Qualified Person	Next edition: 4/8/25	5d	€ 3225.00
Quality Management in Drug Development (Current Module)	Next edition: 6/3/25	2d	€ 2280.00

Practical Information

Difficulty / Level:: Intermediate level and Professional level
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.