Pharmaceutical Industry Drug Regulatory Affairs (DRA)
Empowering Professionals in the Pharmaceutical Industry: A Comprehensive Online Course in Drug Regulatory Affairs
4.34 (1128 reviews)
3 711
students
2.5 hours
content
Feb 2023
last update
$59.99
regular price
What you will learn
Overview of the drug development process
The role of regulatory agencies in drug development and approval
International guidelines and regulations for drug development and approval
The drug registration process in the United States (FDA)
The drug registration process in Europe (EMA)
The importance of good manufacturing practices (GMP)
The principles of pharmacovigilance and adverse event reporting
The regulation of medical devices and combination products
Regulatory strategies for different types of drugs (e.g. orphan drugs, biosimilars)
The impact of intellectual property on drug development and approval
The role of clinical trials in drug development
The regulatory aspects of marketing and advertising of drugs
The regulation of generics and biosimilars
The ethical considerations involved in drug regulation
The future direction of drug regulation and its potential impact on the pharmaceutical industry.
The process and requirements for submitting a new drug application (NDA) or investigational new drug application (IND)
The requirements for post-approval changes and supplements to a drug product
The process and requirements for conducting clinical trials in the US and abroad
The requirements for labeling and packaging of drugs
The role of regulatory agencies in inspections and enforcement
The role of regulatory agencies in risk management and pharmacovigilance
The process and requirements for fast track, breakthrough therapy, and orphan drug designations
The process and requirements for market exclusivity and data protection
The regulatory requirements for advertising and promotion of drugs
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5074068
udemy ID
10/01/2023
course created date
29/01/2023
course indexed date
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