InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$390 USD / 18500 INR.
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drug discovery development to commercialization

Introduction

Course Duration

Eligibility

Certification

Features

Features

Related Courses

Course Content

About RA

drug discovery development to commercialization

This online drug discovery, development and commercialization training course focus on drug development to market commercialization process. The course provides orientation to practical understanding in the entire drug development process. Learn how to manage each steps of the drug development stages effectively. Further, course provide extensive training on clinical trials which is key for the approval of the drug. Fourthly, training includes regulatory pathways for approval. What exactly the requirement from regulatory agency for approving the drug. Lastly, this online training focuses on the market commercialization process. How to launch the drug into the market. And post marketing phase is explained in the course with interactive exercises.

This drug discovery development training course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions. Hence this training provides real life requirement for drug development and commercialization.

The course can be completed at any pace, allowing the user to stop and start at their leisure.

Course Code: RYD-015

Course Title: Advance Certification in Drug Discovery Development to Commercialization

gdlr_tab title=”Course Type”]Online distance learning course. So, course can be accessed online across anywhere 24×7.

1 Year

Any body who wants to acquire drug regulatory affairs competency should attend the course.

Certificate will be provided at the end of the successful completion of the course

  • Orientation to job related practical aspects of the drug regulatory managers, is covered in this course extensively.
  • Simulation to real life working in regulatory affairs department. It help to enhance the regulatory strategic decision making.
  • Advance training on drug registration requirements for various regulatory bodies.
  • Access to Case Studies to learn about the drug registration steps.

Who should attend this course? 

  • Those who are in working in drug discovery and development.
  • Drug Discovery R&D personnel who want advance understanding on drug approval process.
  • Professionals from drug discovery development.
  • Anyone requiring an overview of drug regulatory affairs.
  • Fresher or beginners, Those who want to make a career in drug regulatory department.

Course Timeline

The online drug development process course is broken down into four modules:

  • The Drug Development Process Regulatory Environment. 
  • Training on 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. After that, course provides detailed understanding on the activities needed for regulatory approval, manufacturing scale-up and post-market issues such as adverse event monitoring or reporting and patent exclusivity.
  • Preclinical Steps in Drug Development -Training on the preclinical studies (studies in animal subjects). Topic includes preclinical pharmacology, pharmacokinetic, GLP compliance and more.
  • Clinical Steps in Drug Development –This covers what happens after discovering an NCE, conducting preclinical 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.

Career in Drug Regulatory Affairs

A career in Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

The Pharma and biopharma industry is growing at a rapid pace, but there is a rising concern over the safety and efficacy. Major objective of the regulatory department to maintain safety and efficacy of the drugs and biopharmaceutical molecules. And to maintain safety and efficacy in pharmaceutical and biopharmaceutical products, regulatory agencies like US FDA, EMA, MHRA UK, DCGI, TGA – Autrallia, NMPA – China etc. all over the world are imposing number of regulation. These regulations are evolving and changing every other day. Regulatory professionals must have thorough knowledge about the updated regulations. Sound regulatory knowledge helps them to take strategic decision effectively. This has resulted in creation of regulatory department with certified regulatory affairs professionals. And it help companies to meet these requirements with ease.

About regulatory affairs job>> Learn here

Section 1Fundamental of Drug Discovery and Development
Lecture 1Introduction to R&D Process & drug discovery
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Biological Licensing Application (BLA) 
Lecture 5Basic concept and understanding of the Generic Drug
Lecture 6Abbreviated New Drug Application (ANDA) Filing 
Lecture 7Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 8Handling of orange book
Lecture 9Purple Book: Significance | Searching | Assignments
Lecture 10505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 11Authorized Generics: Key Understanding
Lecture 12Exploratory IND Vs. Traditional IND
Lecture 13Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 14Orphan Drug Designation 
Lecture 15Advance Learning on 505B2 Pathway
Lecture 16Chemistry, Manufacturing & Controls 
Lecture 17Complete Response Letter | Key understanding | Management and Action Plan
Lecture 18USFDA expedited programs
Lecture 19Review on Drug Discovery and Development 
Section 2Clinical Trial Fundamentals
Lecture 20Understanding on Clinical Trials  and Clinical Research 
Lecture 21Clinical Trial Protocol Writing
Lecture 22Ethics in Clinical Research
Lecture 23FDA Forms and How to fill the resources
Lecture 24Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 3Drug Discovery Development to Commercialization - Advance Strategic Planning
Lecture 25Regulatory Strategies in different phases of Clinical Trial
Lecture 26Advance study on Para IV Filing
Lecture 27Para IV Notices
Lecture 28Evergreening - Patent Life Extension Strategies
Lecture 29Pay For Delay Strategy
Lecture 30Authorized Generics: Key Understanding
Lecture 31Licensing & Technology Transfer
Lecture 32In-Licensing Vs. Outlicensing
Lecture 33LOE Strategies for Innovator Brands with case study
Lecture 34Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 35Drug Repurposing
Lecture 36Practical Queries on different USFDA application and Filing 
Lecture 37New Indication Approval Process and Promotion 
Lecture 38OTC Switch