Currently, generic drugs account for a very large percentage of prescriptions. Despite this success, generic drug makers face multiple hurdles to bring these products to the market, from scratch to formulation to regulatory submission and eventual commercialization. In this course, we will guide you through the different steps necessary to achieve the successful production of a generic drug product. Using practical examples, the importance of understanding ‘real-life’ constraints and regulatory requirements will be highlighted. We will focus on the expected timelines, costs and regulatory requirements of the European market, and quickly touch upon some other territories. At the end of the day, you will have acquired knowledge on the following topics:
- Changes in formulation paradigms: how the introduction of PAT and QbD are influencing current practices;
- Scale-up and/or technology transfer: main requirements and possible challenges;
- Registration and validation batches in view of current regulatory specifications;
- Importance of the stability of a drug product;
- Bioequivalence studies: assessment of the performance of the drug in vivo;
- Preparation and submission of a regulatory dossier (timelines and requirements).
This course is intended for those who want to improve their understanding of the overall process of developing generic drug products. The course includes both basic and advanced level topics of interest to QA and QC professionals, staff from chemical production and development departments, and regulatory affairs personnel.
