Quality Management in Drug Development

RENEWED 3.7 343 students

Quality Management in Drug Development

Three days of training. Date: 20-22 September 2022.

RENEWED 3.7 343 students

for pharma & biotech

English Dutch

3 days in total

20-09-2022

€ 2099
excl. VAT

Registration ends in 244 days

This training's start date is guaranteed

What will you learn?

Understand the basic concepts of quality, nonclinical- and clinical drug development

Find, interpret, and understand relevant GxP guidelines and identify the key regulatory requirements for products in development

Identify the location of quality, nonclinical- and clinical data in the Common Technical Document (CTD)

Training contents

Training description

The training

The development of a new therapeutic product is a complicated and expensive process that may take up to 12 years (or more!) before hitting the shelves. Insight into applicable quality management systems, GxPs, and regulatory expectations will help participants minimizing delays and provide clarity on the decisions made along the way.

Previously organized by PAO Farmacie, now by PCS Academy.

Target audience
Professionals in pharmaceutical, biotechnological and medical device industries, Professionals in institutions and Contract Research Organisations (CRO’s), Hospital pharmacists and Postgraduate students.

The course is aimed at (young) professionals in non-clinical and clinical development of new medicinal products, production, packaging, Quality Control, Quality Assurance or Regulatory Affairs who are dealing with complex quality systems. The target audience needs to gain an in-depth understanding of these systems to improve quality management in their own organization. The course is an international training program in English and requires, at minimum, a Bachelor’s Degree level (HBO level in the Netherlands).

What is it about?
This three-day training provides insight into the regulatory requirements for drug development from both the viewpoint of regulatory
authorities as well as inspection bodies. We will explore the development of a new Active Pharmaceutical Ingredient (API), following the principles of Quality by Design. Then non-clinical development is discussed, including toxicology, up to clinical development and manufacturing, referring to GLP, GCP and GMP requirements and regulatory guidelines.

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:

  • Understand the basic concepts of quality, nonclinical- and clinical drug development.
  • Find, interpret, and understand relevant GxP guidelines and identify the key regulatory requirements for products in development.
  • Identify the location of quality, nonclinical- and clinical data in the Common Technical Document (CTD).

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.

Content

  • API – Profile of lead compound: R&D steps and R&D data
  • Medicinal chemistry - Quality in lead finding and optimization
  • Pharmaceutical formulations (incl. development, quality management and GMP)
  • Drug development in Dutch hospital pharmacies
  • Regulatory requirements - quality, clinical and nonclinical (incl. CTD, Clinical Trial Applications)
  • GLP and nonclinical development program
  • Execution of a GLP compliant study
  • GMP during nonclinical and clinical development
  • Clinical development and GCP
    • Clinical phase I, II and III
  • Real-life case studies

More Information
Go to Quality Management in Pharma and Biotech for more information about the 4 modules.

Date                20-22 September 2022
Location         Hotel van der Valk, Breukelen

Discount when following all four modules: 20%
Master and PhD students receive a discount of 25%
Prices exclude exam fees

In the event of cancellation, we refer to the general terms and conditions of PCS (www.pcs-nl.com).

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 Pharma and Biotech
13 days in total Start date: 07-03-2022
4.0 1977 € 7036
Quality Management - The role of the Qualified Person
4 days in total Start date: 07-03-2022
4.1 617 € 2497
Quality Management in Drug Development
3 days in total Start date: 19-09-2022
3.7 343 € 2099

Instructors

Ineke Jonker-Hoogerkamp

Trainer

Ineke is an independent consultant in regulatory affairs and drug development. She has over 25 years of experience in regulatory affairs.

Jan-Jaap Scherpbier

Trainer

Jan-Jaap is an independent consultant in the areas of drug development and regulatory affairs from a CMC perspective.

Quality Management in Drug Development thumbnail
€ 2099
excl. VAT

Registration ends in 244 days

This training's start date is guaranteed

This training includes:

Lunch buffet

Training certificate

Copy of all course materials

Training 5 people or more?

In-house training may be your best choice! We have more than 100 GxP training courses on demand.