Quality Management in Drug Development

3.7 343 students

Quality Management in Drug Development

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.

3.7 343 students

for pharma & biotech

Languages:

3 days in total

€ 2280.00
excl. VAT

Registration ends in 40 days

Register now

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)

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.

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 and biotechnological 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.

Contents


  • 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


Date                20-22 September 2022
Location         Hotel van der Valk, Breukelen
Preparation    Yes, 2-10 hours depending on prior knowledge 
Exam              Yes, optional (re-exam possible) (exams in the week of the 21st of November)

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).

Training contents

26 lectures 3 days in total
    • Quality from a regulatory and GMP perspective
    • Legislation
    • ICH and regional guidelines
    • The Common Technical Document (CTD)
    • Development and manufacture of Drug substance and Drug product
    • Clinical Trial Applications; quality requirements during development

Subject to changes. The final program will be sent to the participants approximately 1 week before the start of the training. No rights can be derived from this program.

Training dates

Training Price From Register
Quality Management in Drug Development
€ 2280.00 20-09-2022 Register now

Languages

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.

4.0 1977 € 7650.00
3.7 343 € 2280.00
4.1 455 € 2280.00
Quality Management in Drug Development thumbnail
€ 2280.00
excl. VAT

Registration ends in 40 days

Register now

This training's start date is guaranteed

This training includes:

26 lectures

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.