InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$290 USD / 14500 INR.
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Drug Development Training

Introduction

Course Duration

Eligibility

Certification

Features

Features

Related Courses

Course Content

drug development

This online drug development training course focus on how the experimental drugs are designed and developed. 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 helps you to understand the practical timeline of the drug development process.

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-096
  • Course Title: Competency Development Training in Drug Development
  • Types of Learning: Online Self Paced Learning

1 Week

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 for the R&D professionals.
  • 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 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 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 / Non-clinical Stage -Training on the preclinical studies (studies in animal subjects). Topic includes preclinical pharmacology, pharmacokinetic, GLP compliance and more.
  • Clinical Steps-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.
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 
Lecture 20Regulatory Requirements for Preformulation Study 
Lecture 21Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies  
Lecture 22Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies 
Lecture 23Types and Timing of Non-clinical Studies 
Lecture 24Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements
Section 2Clinical Trial Fundamentals
Lecture 25Understanding on Clinical Trials  and Clinical Research 
Lecture 26Clinical Trial Protocol Writing
Lecture 27Ethics in Clinical Research
Lecture 28FDA Forms and How to fill the resources
Lecture 29Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Section 3Drug Discovery Development to Commercialization - Advance Strategic Planning
Lecture 30Regulatory Strategies in different phases of Clinical Trial
Lecture 31Advance study on Para IV Filing
Lecture 32Para IV Notices
Lecture 33Evergreening - Patent Life Extension Strategies
Lecture 34Pay For Delay Strategy
Lecture 35Authorized Generics: Key Understanding
Lecture 36Licensing & Technology Transfer
Lecture 37In-Licensing Vs. Outlicensing
Lecture 38LOE Strategies for Innovator Brands with case study
Lecture 39Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 40Drug Repurposing
Lecture 41Practical Queries on different USFDA application and Filing 
Lecture 42New Indication Approval Process and Promotion 
Lecture 43OTC Switch 
Lecture 44Target product profile (TPP) | Quality Target product profile (QTPP) | Critical Quality Attributes (CQAs) | Quality By Design (QbD)