Public-registration training

Quality Management in Drug Development

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

This training includes:

Upcoming edition starts 27-09-2023

Quality Management in Drug Development

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

2 days in total
343 students
Upcoming edition starts 27-09-2023

Quality Management in Drug Development

What you will learn

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)

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

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Training language(s)

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 two-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

Training program

The program is subject to change. 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 date(s)

Start dateEnd dateVenuePriceStatus
27-09-202328-09-2023Van der Valk Utrecht 2.280 ex. VATOpen for registration
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Lecturer(s)

Registration

To start your registration, first select the start date of the training, then fill in the form below.

Upon passing the exam, you will receive a Certificate of Competence. The exam is optional.

Participants
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General information

Learning form:Classroom
Times:The course starts at approx. 9:00 am and ends at approx. 5:00 pm
Venue(s):
Start dateVenueRegister

27-09-2023

Van der Valk Utrecht

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

Register now!

Register for this training by clicking the button.