Drug Regulatory Affairs
Description
Welcome to Pharmastate Academy’s comprehensive course on Drug Regulatory Affairs in the Pharmaceutical Landscape. Unravel the significance of regulatory affairs in the pharmaceutical realm, exploring its pivotal role in different countries.
Through this course, delve into the crucial elements of drug discovery and drug development phases, from preclinical studies to clinical trial studies.
Understand various regulatory concepts including Code of Federal Regulations, Federal Register, Purple Book, and Orange Book. Gain insights into the structure and organization of Common Technical Documents (CTD).
Explore the diverse classifications of Drug Master File Applications, from Open Part DMF to Letter of Authorization DMF categories.
Join us on this insightful journey to grasp the essence of drug regulatory affairs, navigating through regulatory requirements, submission procedures, timelines, and FDA review processes. Enroll now for a comprehensive learning experience that will empower you in the world of pharmaceutical quality.
- This course has a 1450+ Star Rating & an Average Rating of 4.6/5.
- 4500+ Students have enrolled in the course till now.
- It is one of the highest-rated online certificate courses on Drug Regulatory Affairs.
Enroll in the course to learn the fundamentals of Drug Regulatory Affairs.
In this course learn about the basics of drug regulatory affairs and regulations of drug development.
Regulatory affairs is a profession within regulated industries, such as pharmaceuticals and medical devices, ensuring that their companies comply with all the regulations and laws pertaining to their business.
This course encompasses a series of enlightening lessons, including an introduction to Regulatory Affairs, a deep dive into drug development regulation, an insightful perspective on the Product Life Cycle from a Regulatory Affairs standpoint, understanding the pivotal role of Regulatory Affairs within a pharmaceutical company, and mastering essential regulatory documentation and tools. Gain valuable insights and practical knowledge to thrive in the dynamic and evolving landscape of drug regulatory affairs. Enroll in the course to elevate your understanding of the critical intersections between pharmaceuticals and compliance, setting the foundation for a successful career in this vital industry.
Today we will understand the role of these regulatory affairs in the pharma industry.
Language: English
Course Curriculum
1. Drug Regulatory Affairs
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1.1 – Introduction
02:41 -
1.2 Introduction
03:22 -
Quiz: Introduction
2. Regulatory Framework in the pharmaceutical industries
3. Stages of Drug Discovery
4. Drug Development Process
5. Registration and Approval process for the Documentations
6. Regulatory Concepts
7. Pharmacovigilance and Post-Marketing Surveillance
8. Case Studies
9. Final Assessment
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Course Ratings & Reviews
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Course Ratings & Reviews
I liked the case studies.
A few more details and case studies can be added on each topic if possible.