Empowering Professionals in the Pharmaceutical Industry: A Comprehensive Online Course in Drug Regulatory Affairs
What you'll learn
Overview of Drug Regulatory Affairs in Pharma Industry
Different terms used in Pharma Industry by Regulatory Professional, which will help in the Regulatory Affair career
Historical Perspective of Drug Regulatory Affairs and different challenges
Journey of Drug from Discovery to Marketing
Drug Composition and Formulation
Different documentations : IND, NDA, ANDA, BLA
CTD and eCTD (Common Technical Document)
Dossiers
ESG and ESG web interface
Drug Registration
API ( Active Pharmaceutical Ingredients) and Excipients , DMF (Drug Master File)
Regulatory Compliance and Agencies
Different Clinical Trials In pharma industries
Approvals of Drug for Marketing
Pandemic Situations Approval of Drugs
Requirements
There Are No Requirements Necessary To Enroll. I Only Ask To Come Open-Minded And Ready To Learn.
Description
The drug regulatory affairs course is designed to provide professionals in the pharmaceutical industry with a comprehensive understanding of the drug development process and the regulations that govern it. Here are some key points about the course:Introduction to drug regulatory affairs: The course begins with an overview of drug development and the role of regulatory agencies like the FDA and EMA. Students will learn about international guidelines and regulations.Drug registration process: Students will gain a detailed understanding of the drug registration process in the United States, Europe, and other major markets. This includes learning about the stages of drug development and post-approval changes.Regulation of medical devices and combination products: Students will learn about the regulatory requirements for medical devices and combination products, which involve the combination of drugs and devices.Regulatory TermsClinical trials and marketing regulations: The role of clinical trials in drug development and the regulatory aspects of marketing and advertising drugs are covered. The course also addresses the changing regulatory landscape due to technological advancements.Submission requirements and post-approval changes: Students will learn about the process and requirements for submitting a new drug application (NDA) or investigational new drug application (IND). They will also understand the requirements for post-approval changes and supplements to a drug product.Fast track: The course covers the process and requirements for these special designations that facilitate expedited development and approval of drugs.Documentation: Students will learn about the various forms of documentation, electronic documentation, web gateways, and tools used during regulatory submissions.Online learning and practical application: The course is delivered online, allowing students to learn at their own pace. They will engage in interactive sessions, and apply their knowledge to real-world scenarios.By completing this course, students will be equipped with a deep understanding of the drug regulatory process and will be prepared to navigate the complex regulations governing the pharmaceutical industry.
Overview
Section 1: Introduction
Lecture 1 Introduction: Regulatory Affairs
Section 2: History, Role, and Challenges of Regulatory Affair
Lecture 2 History, Role and Challenges
Section 3: Documentation
Lecture 3 CTD: Common Technical Document
Lecture 4 eCTD
Lecture 5 Documentations Done in Pharma Industries: Regulatory
Section 4: Gateways and Web Tools in Pharma Regulatory Affairs
Lecture 6 ESG and ESG Web Interface
Lecture 7 Web Software Tools in Regulatory Pharma Industry
Section 5: Journey of Drug
Lecture 8 API and Excipients
Lecture 9 From Drug Discovery to Market
Lecture 10 Drug Composition and Formulation
Section 6: Registration
Lecture 11 Drug Registration
Section 7: Clinical Trials
Lecture 12 Clinical Trials Phase I, II, III and IV
Section 8: Bonus Lecture : Pandemic Situation Approval of Drugs
Lecture 13 EUA
Lecture 14 QSEM
The Ideal Student For This Course Is Anyone Who Wants To Learn About 'Pharmaceutical Regulatory Affairs' Or An Existing Professional Who Wants To Expand On Their Current Skills.
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