TypeOnline Course
Price$90 / Rs. 5400
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Admission Process

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Fundamental Training in Drug Discovery to Commercialization Pathway

Fundamental Training in Drug Discovery to Commercialization Pathway by nckpharma

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

Course Objectives: In the fields of medicine, biotechnology and pharmacology, drug discovery, development is the process by which new candidate medications are discovered. 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 commericialization 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.

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

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

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 6Review on Drug Discovery and Development 
Lecture 7Simulation in Drug Discovery and Development
Lecture 8505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 9Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 10Clinical Trial - Fundamental
Section 2Final Examination