TypeOnline Course
(1 ratings)
Buy NowBook Now

Course Code: KPE-C-054

Course Title: Fundamental Training in Drug Regulatory Affairs

Type of Course: Online Certification Course

Course Duration: 1 Week

Course Certification: Yes. Course completion and Course gradation certificate will be provided

Course Objectives: The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities. Regulatory affairs professionals are involved in product development from the beginning. Regulatory restraints and requirements need to be considered when drafting the pharmaceutical, preclinical and clinical development plan.

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 drug regulatory department
  • Those who are in regulatory affairs and related department
  • 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

Additional Resource: 

  • View comparison of 1 Week, 1 Month, 1 Year Advance and 1 Year Executive Program >> Click here
Section 1Download Study Module and Course Introduction
Section 2R&D Drug Discovery Development Commercialization and Related Regulatory Understanding
Lecture 2R&D Process & Introduction to drug discovery 
Lecture 3Investigational New Drug Application (INDA)
Lecture 4New Drug Application (NDA) 
Lecture 5Biological Licensing Application (BLA) 
Lecture 6Basic concept and understanding of the Generic Drug
Lecture 7Abbreviated New Drug Application (ANDA) 
Lecture 8Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 9Handling of orange book
Lecture 10Purple Book: Significance | Searching | Assignments
Lecture 11505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Authorized Generics: Key Understanding
Lecture 13Exploratory IND Vs. Traditional IND
Lecture 14Advance Learning on 505B2 Pathway
Lecture 15Chemistry, Manufacturing & Controls 
Lecture 16Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 17Clinical Trials Terminologies 
Lecture 18Clinical Trial Protocol Writing
Lecture 19Ethics in Clinical Research
Lecture 20Informed Consent | Practical Training in Preparing ICF | Templates
Section 3Final Examination