Quality Management in Drug Development
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.
for pharma & biotech
Languages:
3 days in total
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
Previously organized by PAO Farmacie, now by PCS Academy.
Target audience
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
The course is highly interactive. The program is offered as a combination of self-study, theory, and practical case studies.
Learning goals
- 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
- 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
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Quality from a regulatory and GMP perspective
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Legislation
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ICH and regional guidelines
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The Common Technical Document (CTD)
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Development and manufacture of Drug substance and Drug product
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Clinical Trial Applications; quality requirements during development
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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
- English spoken languageDutch secondary spoken languageEnglish course materials
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.
