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.
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.
Expert knowledge and real-life case studies are combined to form an ideal learning experience. Professionals from industry, academia and national regulatory authorities such as Dutch IGJ 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.
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).
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.
- 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
- Perspective of the Dutch Inspectorate for Healthcare and Youth (IGJ)
- Real-life case studies
Go to Quality Management in Pharma and Biotech for more information about the 4 modules.
Date 14-16 September 2021
Location Hotel van der Valk, Breukelen
Discount when following all four modules: 20%
Master and PhD students receive a discount of 25%
The fee includes course notes, hotel accommodation, drinks, lunches and dinners. In the event of cancellation, we refer to the general terms and conditions of PCS (www.pcs-nl.com).
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