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. This course is intended for those who want to improve their understanding of the overall process of developing generic drug products.
Scope Provided by this Training:
- 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).
Who Should Attend:
- Formulation Managers;
- Manufacturing Process Managers;
- Process Development Scientist;
- Process Engineers;
- Technology Transfer Specialist;
- Manufacturing Managers.
This training has already been successfully delivered in an online format in cooperation with Symmetric
