Public-registration training
Quality Management in Drug Development
This two-day training provides insight into the regulatory requirements for drug development
Quality Management in 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)
Understand the basic concepts of quality, nonclinical- and clinical drug 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. 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
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.
Start date End date Venue Price Status 27-09-2023 28-09-2023 Van der Valk Utrecht € 2.280 ex. VAT Open for registration Need training sooner?Click here to get personal training options.
Christine Mitchell
Module Leader, Senior GCP/GLP Consultant & Trainer
Christine Mitchell
To start your registration, first select the start date of the training, then fill in the form below.
Register now!
Register for this training by clicking the button.Drag the table left or right to reveal all fields.Learning form: Classroom Times: The course starts at approx. 9:00 am and ends at approx. 5:00 pm Venue(s): Start date Venue Register 27-09-2023
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
€ 2.280 ex. VAT
Training certificate
Lunch buffet
Course dinner
An in-house training is your best choice! We have more than 100 GxP in-house training courses on request.
