Introduction
Features
Duration
Eligibility
Syllabus
Course Description
This online drug development training course utilizes interactive learning tools to guide each participant through the steps of the drug development process. 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.
Course Title: KPE’s Certificate Program in Drug Development Process: Discovery to Commercialization
Course Objective: The objective of this course is to impart knowledge and understanding of the Drug Development Process – from discovery to commercialization – different strategic planning involved in the different phases.
1. Orientation to practical understanding in the entire drug development process
2. Simulation to real life Strategic planning in drug discovery and development process management.
3. Access to Industry Databank – 300 Strategic Management examples etc.
4. Access to case studies on drug discovery management Studies
5. Attend Live Lectures of all different chapters / study content.
1 Month
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.
The online drug development process course is broken down into four modules:
The Drug Development Process Regulatory Environment – It also offers a perspective into global regulatory entities, as each country is equipped with its own laws, regulations and guidelines.
Stages in the Drug Development Process – the second module provides a detailed overview of the drug development process, taking a look at the life cycle, history, timelines and phases critical to the process. The module covers the product discovery and clinical testing steps essential to the early stages of the drug development process. This is followed by the activities needed for regulatory approval, manufacturing scale-up and post-market issues such as adverse event monitoring/reporting and patent exclusivity.
Pre-Clinical Steps in Drug Development – the third module is centered on the pre-clinical studies used to see if a product is reasonably safe for animal subjects and later for human testing. Subjects include pre-clinical pharmacology, pharmacokinetics, GLP compliance and more.
Clinical Steps in Drug Development –This covers what happens after discovering an NCE, conducting pre-clinical trials and completing the IND/CTA application. Attendees will learn the different phases of these clinical studies and about the NDA/MAA application.
Launching and marketing of Innovative Branded Drug – marketing planning, strategic initiative, usage of clinical trial in marketing, Product Life cycle Management, forward and backward integration for the branded pharmaceuticals for managing high ROI.
