Quality Management in Drug Development

343 students

Quality Management in Drug Development

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.

343 students

GMP & GDP training for pharma & biotech

Language(s):

2 days in total

€ 2.280 ex. VAT

Registration ends in 53 days.

Register Now Download Brochure

The upcoming start date of this training is guaranteed.

What you'll 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 and apply that knowledge to ensure product quality, patient safety and compliance with standards.

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.

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. Previously organized by PAO Farmacie, now by PCS Academy.

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.

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.

Learning goals

After having followed this course, you will be able to:
  • 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 and apply that knowledge to ensure product quality, patient safety and compliance with standards.
  • 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.
  • 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.

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.

Contents

  • 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
Course content

Program - Day 1
Program - Day 2
LectureDay
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
LectureDay
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 including changes, deviations and their impact on the registration dossier

 2
Reflection and closure

2

Course dates

Start dateEnd dateVenuePriceStatus
11-06-202412-06-2024Hotel Mitland€ 2.280 ex. VATRegister

Language

  • Dutch secondary spoken language
    Some lectures/lessons may be in the secondary language. The primary language remains the dominant spoken/written language during the training.
  • English spoken language

General information

Learning form:Classroom
Times:The course starts at approx. 9:00 am and ends at approx. 6:00 pm
Venue(s):
Start dateVenueRegister

11-06-2024

Hotel Mitland

Register

Preparation:
Preparation required:Yes
Preparation details:Homework
Exam:
Includes exam:Yes
Exam optional:Yes
Re-examination possible:Yes
Exam fee in course price:No
Examination fee for each exam attempt:350

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.

Quality Management in Manufacturing of Biopharmaceuticals
3 days in total
4.1 560 € 2.590 ex. VAT
Quality Management in Sterile Manufacturing
3 days in total
4.1 455 € 2.590 ex. VAT
Quality Management - The Role of the Qualified Person
5 days in total
4.3 617 € 3.225 ex. VAT
Quality Management in Drug Development
2 days in total
3.7 343 € 2.280 ex. VAT
Quality Management in Drug Development thumbnail
€ 2.280 ex. VAT

Registration ends in 53 days.

Register Now Download Brochure

The upcoming start date of this training is guaranteed.

This training includes:

Training certificate

Lunch buffet

Course dinner

17 Lectures

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