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Updated in [September 26th, 2023]

What does this course tell?
(Please note that the following overview content is from the original platform)
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.

We considered the value of this course from many aspects, and finally summarized it for you from two aspects: skills and knowledge, and the people who benefit from it:
(Please note that our content is optimized through artificial intelligence tools and carefully reviewed by our editorial staff.)
What skills and knowledge will you acquire during this course?During the Pharmaceutical Drug Regulatory Affairs (DRA) 2023 course, students will acquire the following skills and knowledge:
1. Understanding of drug development process: Students will gain a comprehensive understanding of the drug development process, including the various stages involved from preclinical research to clinical trials.
2. Knowledge of regulatory agencies and guidelines: Students will learn about the role and functions of regulatory agencies such as the FDA and EMA. They will also become familiar with international guidelines and regulations governing drug development.
3. Drug registration process: Students will gain a detailed understanding of the drug registration process in major markets like the United States and Europe. This includes learning about the requirements and procedures for submitting a new drug application (NDA) or investigational new drug application (IND).
4. 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. They will understand the specific regulations governing these products.
5. Knowledge of clinical trials and marketing regulations: The course covers the role of clinical trials in drug development and the regulatory aspects of marketing and advertising drugs. Students will learn about the regulations governing these activities.
6. Understanding of 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.
7. Familiarity with fast track designations: The course covers the process and requirements for special designations like fast track, which facilitate expedited development and approval of drugs. Students will understand the benefits and criteria for obtaining these designations.
8. Knowledge of documentation: Students will learn about the various forms of documentation used during regulatory submissions, including electronic documentation, web gateways, and tools. They will understand the importance of accurate and complete documentation.
9. 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, enhancing their practical skills.
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.

Who will benefit from this course?
Professionals in the pharmaceutical industry, specifically those involved in drug development, regulatory affairs, and compliance, will benefit from this course. This includes individuals working in pharmaceutical companies, regulatory agencies, contract research organizations (CROs), and clinical research organizations (CROs).

Pharmaceutical executives and managers will benefit from gaining a comprehensive understanding of the drug development process and the regulations that govern it. This knowledge will enable them to make informed decisions and effectively navigate the regulatory landscape.

Regulatory affairs professionals will benefit from the course by enhancing their knowledge and skills in drug regulatory affairs. They will gain a deep understanding of the drug registration process, including the stages of drug development and post-approval changes. This will enable them to effectively manage regulatory submissions and ensure compliance with international guidelines and regulations.

Clinical research professionals will benefit from learning about the role of clinical trials in drug development and the regulatory aspects of marketing and advertising drugs. This knowledge will enable them to design and conduct clinical trials in accordance with regulatory requirements.

Quality assurance professionals will benefit from understanding the regulatory requirements for medical devices and combination products. This knowledge will enable them to ensure compliance and quality control in the development and manufacturing of these products.

Pharmaceutical scientists and researchers will benefit from gaining a comprehensive understanding of the drug regulatory process. This knowledge will enable them to design and conduct research studies in accordance with regulatory requirements and contribute to the development of safe and effective drugs.

Course Syllabus

Introduction

History, Role, and Challenges of Regulatory Affair

Documentation

Gateways and Web Tools in Pharma Regulatory Affairs

Journey of Drug

Registration

Clinical Trials

Bonus Lecture : Pandemic Situation Approval of Drugs