TypeOnline Course
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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.

Section 1Fundamental Training on Drug Discovery and Development
Lecture 1R&D Process & Introduction to drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Basic concept and understanding of the Generic Drug & ANDA Filing
Lecture 5Review on Drug Discovery and Development 
Lecture 6Generic Drug User Fees Act  (GDUFA)
Lecture 7Prescription Drug User Fees Act (PDUFA)
Lecture 8Handling of orange book
Lecture 9Expedited Program
Lecture 10Practical Training on INDA, NDA, ANDA filing
Lecture 11505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Authorized Generics: Key Understanding
Lecture 13Exploratory IND Vs. Traditional IND
Lecture 14Patents Vs. exclusivity 
Lecture 15Orphan Drug Designation 
Lecture 16Clinical Trials Terminologies 
Lecture 17Clinical Trial Protocol Writing
Lecture 18Ethics in Clinical Research
Lecture 19Informed Consent 
Lecture 20FDA Forms and How to fill the resources
Lecture 21Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 22505B2 Pathway
Section 2Discovery to Commercialization - Strategic Planning
Lecture 23Regulatory Strategies in different phases of Clinical Trial
Lecture 24Advance study on Para IV Filing
Lecture 25Para IV Notices
Lecture 26Evergreening - Patent Life Extension Strategies
Lecture 27Pay For Delay Strategy
Lecture 28REMS Strategic Planning 
Lecture 29Compulsory Licensing
Lecture 30Licensing & Technology Transfer
Lecture 31In-Licensing Vs. Outlicensing
Lecture 32LOE Strategies for Innovator Brands with case study
Lecture 33Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 34Drug Repurposing