TypeOnline Course
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Fundamental Training in Drug Discovery to Commercialization Pathway

Drug Discovery to Commercialization Pathway is a short online course provides training on new drug is commercialized step by step. Hence, the objective of the course is to provide simulation based understanding of drug discovery, development stages and commercialization process.

In the fields of medicine, biotechnology and pharmacology, drug discovery, development is the process by which new candidate medications are commercialized. Once a compound that fulfills all of these requirements has been identified, the process of drug development can continue, and, if successful, clinical trials. Followed by that market commercialization will take place.

In this online self-paced modules, participant will be understanding about the drug development to commercialization process in detail. Stages of drug discovery and development, Investigational new drug application, new drug application, handling of different phases of clinical trial, generic drug approval process, Abbreviated new drug applications will be covered in phased manner for easy understanding.

  • Course Code: KPE-C-079
  • Course Title: Fundamental Training in Drug Discovery to Commercialization Pathway
  • Type of Course: Online Certification Course
  • Course Duration: 1 Week
  • Course Certification: Yes. Course completion and Course gradation certificate will be provided

Who should attend this course? 

  • Fresher/Beginners, Those who want to make a career in marketing, sales, strategic management, business development professionals for clear understanding of the drug discovery process
  • Professionals from drug discovery development
  • Anyone requiring an overview of drug regulatory affairs fundamental knowledge
Section 1R&D Drug Discovery Development Commercialization and Related Regulatory Understanding
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
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 7Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 8Clinical Trial - Fundamental
Lecture 9Clinical Trial Protocol Writing
Lecture 10Ethics in Clinical Research
Lecture 11Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 12Biological Licensing Application (BLA) 
Lecture 13Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 14Handling of orange book
Lecture 15Purple Book: Significance | Searching | Assignments
Lecture 16USFDA expedited programs
Lecture 17Practical Training on INDA, NDA, ANDA filing
Lecture 18Authorized Generics: Key Understanding
Lecture 19Exploratory IND Vs. Traditional IND
Lecture 20Orphan Drug Designation
Lecture 21Advance Learning on 505B2 Pathway
Lecture 22Simulation on Drug Discovery and Development 
Lecture 23Review on Drug Discovery and Development 
Section 2Final Examination