Industrial Pharmacy II
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Questions and Answers

What is the primary goal of Regulatory Affairs (RA) or Government Affairs?

The primary goal is to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, foods, cosmetics and complementary medicines.

What specific skills and occupations does regulatory affairs cover?

Regulatory affairs cover a broad range of specific skills and occupations.

Why is drug development to commercialization highly regulated?

Every drug before getting market approval must undergo scrutiny and clinical trials to ensure its safety, efficacy, and quality.

What is the role of people working in regulatory affairs?

<p>They act as a liaison between the government, industry, and consumers to ensure that marketed products are safe and effective when used as advertised.</p> Signup and view all the answers

What does Pharmaceutical Drug Regulatory Affairs (DRA) encompass?

<p>It encompasses the scientific, legal, and commercial aspects of drug development.</p> Signup and view all the answers

Flashcards

Regulatory Affairs Goal

To protect public health by ensuring the safety and efficacy of products like pharmaceuticals, medical devices, and food.

Drug Development Regulation

Rigorous process of testing and approval to ensure drug safety, effectiveness, and quality before market release.

Regulatory Affairs Skills

Includes a broad range of skills encompassing scientific knowledge, legal expertise, and industry understanding in relation to products regulation.

Regulatory Affairs Role

Liaison between the government, industry, and consumers to ensure product safety and effectiveness.

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Pharmaceutical Drug Regulatory Affairs

A specialised aspect of regulatory affairs focusing on the science, law, and business side of drug development and approval

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