Q course - Module 2: Quality Management in Drug Development

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Q course - Module 2: Quality Management in Drug Development

Pharmaceutical Consultancy Services (PCS)
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Opleiderscore: starstarstarstarstar_half 9,2 Pharmaceutical Consultancy Services (PCS) heeft een gemiddelde beoordeling van 9,2 (uit 5 ervaringen)

Tip: meer info over het programma, prijs, en inschrijven? Download de brochure!

Startdata en plaatsen

placeMitland, Utrecht
11 jun. 2024 tot 12 jun. 2024

Beschrijving

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 …

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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. 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:

  • 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

Do you want to register for this training, this is possible through our website: https://pcs-nl.com/product/quality-management-in-drug-development-2/. Or send us an email at courses@pcs-nl.com.

PCS - The Practical Compliance Specialists since 1990

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