InstructorRoyed Training
TypeOnline Course
Price$225 USD / 12375 INR
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New Drug Approval Training


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About New Drug

New Drug Approval Process Training

This New Drug Approval short orientation training provides fundamental understanding of regulation and approval of the novel innovator pharmaceuticals. The course briefs how the new drugs are discovered and developed and commercialized.

New novel innovator molecule development is not a easy task. Drug development is a lengthy, complex, and costly process. It has a high degree of uncertainty that a drug will actually succeed. Regulatory, Business Development, Sales Management or even business development managers should have fundamental understanding of the new drug development process.

In this online self-paced modules, participant will be understanding about the new drug development to commercialization process in detail. The course provide valuable insight on stages of drug discovery and development, investigational new drug application, new drug application, handling of different phases of clinical trials.

Course Code: RYD-063

Course Title: Fundamental Training in New Drug Approval

Online micro learning course. So, course can be accessed online across anywhere 24×7.

Duration: 3 Days

Any body who wants to acquire detailed understanding on new drug approval pathway, should attend the course.

Any body who wants to acquire competency regarding new drug development process, should attend the course.

Who should attend this course? 

  • This course is ideal for those who requires fundamental understanding on the drug discovery, development to commercialization process for new innovator drugs.
  • Fresher/Beginners, Those who want to make a career in drug regulatory department.

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

  • This course provides orientation to new drug development process. Hence, this course is ideal for those who wants quick understanding of new drug approval process.
  • The course briefs step by step process for registering new drug.
  • Moreover, course also provide clear cut understanding of the clinical trials which new drugs has to undergo effectively.
  • Advance training on drug registration requirements for various regulatory bodies.

New Drug

A new drug is an experimental drug. This experimental medication or therapy is not used that has not been used before in clinical practice to treat a disease or condition. Hence, a new drug needs marketing authorization before it that is marketed must first obtain approval from the regulatory body. New drug application process is the submissions of the marketing authorization application.

How a New Drug Gets Approved?

The process of getting a new drug to market involves certain logical steps. In this course we will be understanding how these logical steps are performed in pharmaceutical companies.

  • Development of a new drug molecule.
  • Animal tests for toxicity, to ensure the compound is safe for humans
  • Investigational New Drug (IND) application to the NDA
  • Clinical Trials
  • Phase 1 clinical trials or studies, where the emphasis is on the drug’s safety and side effects
  • In Phase 2 clinical trials, where the focus is on the proposed drug’s effectiveness
  • Finally, in Phase 3 clinical trials, which are very large, multi-stage trials that gather more information about the drug’s safety and effectiveness
  • New Drug Application (NDA) to the FDA, which is a comprehensive document containing all the above information
  • NDA review by the FDA
  • Drug labeling review and facility inspection by the FDA
  • Drug approval (or rejection) by the FDA

About regulatory affairs job>> Learn here

Section 1Learning Sessions
Lecture 1R&D Process & Introduction to drug discovery 
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Review of Drug Discovery Development 
Lecture 5Exploratory IND Vs. Traditional IND
Lecture 6USFDA expedited programs
Lecture 7505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 8Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 9Advance Learning on 505B2 Pathway
Lecture 10Chemistry, Manufacturing & Controls 
Lecture 11Understanding on Clinical Trials  and Clinical Research 
Lecture 12Clinical Trials Terminologies 
Lecture 13Clinical Trial Protocol Writing
Lecture 14Ethics in Clinical Research
Lecture 15Informed Consent | Practical Training on preparing ICF | Ready Templates
Lecture 16FDA Forms and How to fill the resources
Lecture 17Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !
Lecture 18Common Technical Document (CTD)
Lecture 19CMC Dossier & Compliance Management
Section 2Final Certification Examination