The Complex Generic Course will address the critical development stages and determination of QTPP for such a product as well as defining the mission statement effectively initially. It will identify key decision for comparators and for selection of batches for BE studies. It will ensure developers now what companies are looking for and allow effective due diligence. The course will teach you how to bring a generic drug / complex generic drug to market whilst assuring you meet the regulatory challenges and compliance issues. This course will allow the participants to gain a strategic insight into key requirements for developing generics from a global perspective
and an overview of the generics market; current trends and practices; and future strategies for regulatory compliance. There will be time on this course to discuss the likely implications of CMC decision and BE decision / outcomes on the strategies for Generics
Regarding CMC Sections of the CTD is a very practical presentation set incorporating key element of PAT and QbD with respect to needs for global dossier, use of FMEA and effective linkage of CQAs and CPP to material attributes using techniques in QbD triangle practical which is used by multiple companies both small and large. The definitions and level of data expected is addressed with anecdotes provided. Furthermore the Quality and Pharmaceutical Module (Module 3) of the CTD is challenging and requires considerable expertise to manage it. This course will provide you with a clear understanding of the US and European regulatory requirements for Module 3, PAT and QbD, and will show you how to compile this important part of your
submission dossier. The Indian pharmaceutical industry has been undergoing a significant transformation to streamline their Research and Development (R&D) process, provide greater manufacturing flexibility and control, and to reduce regulatory burden.