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

Admission Process

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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 Fees: 25 USD | 1500 Indian Rupees

Course Syllabus | Course Flow | Content 

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

Section 1Drug Discovery and Development
Section 2IND
Section 3NDA
Section 4Generic Drug
Section 5Review of Drug Discovery & Development
Section 6Expedited Review
Section 7Review / Case Study on INDA, NDA, ANDA filing
Section 8505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Section 9Authorized Generics: Key Understanding
Section 10Advance Learning on 505B2 Pathway
Section 11Final Certification