Course Title: KPE’s Certificate Program in Drug Registration and Dossier Preparations.
Course Objective: The objective of this course is to impart knowledge and understanding of Drug Registration and Dossier Preparation.
This online course utilizes interactive learning tools to guide each participant through the steps of drug regulation and registration process for different regulatory bodies and practical exposure in drug dossier preparation. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.
The course can be completed at any pace, allowing the user to stop and start at their leisure.
1. Orientation to practical understanding in the entire drug regulation in brief, drug registration process of different regulatory bodies and practical exposure on Drug Dossier Preparation.
2. Technical Documents and guidelines on dossier preparation
2. Simulation to real life Strategic planning in Drug Registration Process
3. Access to Industry Data bank
4. Attend Live Lectures of all different chapters / study content.
B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.
This course is divided into following modules
1. Overview of the Drug Regulation and different regulatory bodies. Basic in-depth Training on regulatory affairs.
2. Drug Registration Process.
3. Drug Dossier and its components.
4. Page by page development of Drug Dossier Preparation.