TypeOnline Course
(1 ratings)
Price$25 / Rs. 1500
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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? 

  • Those who are in regulatory affairs and related department
  • Professionals from drug discovery development
  • Anyone requiring an overview of drug regulatory affairs
  • Fresher/Beginners, Those who want to make a career in drug regulatory department

Duration: Access Available for 1 Day

Course Code: KPE-C-058

Course Syllabus | Course Flow | Content 

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

Section 1Drug Discovery and Development
Lecture 1Drug Discovery and Development
Lecture 2Investigational New Drug Application (INDA)
Lecture 3New Drug Application (NDA) 
Lecture 4Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 5Abbreviated New Drug Application (ANDA) 
Lecture 6Abbreviated New Drug Application (ANDA) 
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 8Orange Book
Lecture 9Purple Book: Significance | Searching | Assignments
Lecture 10USFDA expedited programs
Lecture 11505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 12Advance Learning on 505B2 Pathway
Section 2Final Certification