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DRA Intro and Scope

This document provides an overview of drug regulatory affairs. It discusses the role of regulatory affairs professionals in ensuring pharmaceutical products comply with regulations from initial application through marketing. The course aims to create experts in regulatory affairs documentation and provide an entry point into the field for graduates. The course structure covers regulatory strategy, marketing authorization, non-clinical and clinical studies, and good manufacturing practice. Graduates will be able to write regulatory documents, create regulatory strategies, and obtain marketing authorization in different countries. Regulatory affairs professionals have career opportunities in pharmaceutical, medical device, and other health-related companies as well as with regulatory bodies and clinical research organizations. Emerging opportunities exist in Asia, particularly India and the United Arab Emirates, as the pharmaceutical industry

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793 views12 pages

DRA Intro and Scope

This document provides an overview of drug regulatory affairs. It discusses the role of regulatory affairs professionals in ensuring pharmaceutical products comply with regulations from initial application through marketing. The course aims to create experts in regulatory affairs documentation and provide an entry point into the field for graduates. The course structure covers regulatory strategy, marketing authorization, non-clinical and clinical studies, and good manufacturing practice. Graduates will be able to write regulatory documents, create regulatory strategies, and obtain marketing authorization in different countries. Regulatory affairs professionals have career opportunities in pharmaceutical, medical device, and other health-related companies as well as with regulatory bodies and clinical research organizations. Emerging opportunities exist in Asia, particularly India and the United Arab Emirates, as the pharmaceutical industry

Uploaded by

Jbelsen David
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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DRUG REGULATORY AFFAIRS

Introduction & Scope

Contents
Introduction Course objective Course structure Learning outcome Carrier opportunities Types of companies hiring RA professionals Emerging opportunity Market Review RA professional can get employment as

Introduction
Drug regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry. Those working in pharma regulatory affairs jobs not only work in the initial application phase for a new or generic drug, but also in the licensing and marketing stages making sure all operations and products meet required safety and efficacy standards

Course Objective
To create a thorough understanding of important regulatory concepts To create experts in the field of RA documentation and research. To create an entry platform in the field of RA for fresh graduates. To help students build their career in RA and become RA professionals. To provide students with a global knowledge of Regulatory Affairs.

Course Structure
The Aims & Structure of Regulation

Regulatory Strategy
Marketing Authorization

Non Clinical Studies


Clinical Trials

Good Manufacturing Practice (GMP)

Learning Outcome
Able to write Regulatory Documents Create Regulatory Strategy Get Marketing Authorization from different countries Become an RA professional

Career Opportunities
A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance and others are considered regulatory professionals.

Type of companies hiring RA professionals


Pharmaceutical Medical Devices In Vitro Diagnostics Biologics and Biotechnology Veterinary Products Cosmetics Local governing bodies Ministry of Health Clinical Research Organization/ Contract Research Organization Pharmaceutical consultancy companies

Emerging opportunity
Asia has emerged as a strong growth region for the pharmaceutical industry in recent years, in particular India which is fast becoming a preferred location for clinical trials, research and development activities.

The creation of a new product patent system in 2005 was a driver of this growth, which is expected to increase as the domestic market in India further opens up. This growth has also helped facilitate an increasing number of pharma regulatory affairs jobs in India.

Market Review
According to companiesandmarkets.com report By the year 2012 the market for clinical trials in India is expected to grow to $630 million (404 million), helped by the fact that the cost of conducting research in the country is sometimes less than half that in more developed nations. The United Arab Emirates (UAE) is also looking to expand its appeal to the pharmaceutical industry by increasing the number of pharma regulatory affairs jobs in Dubai. Accordingly an compound annual growth of 17 per cent will take place between 2010 and 2013 and that the UAE is ripe for investment for Pharmaceutical manufacturing operations.

RA professional can get employment as:


Regulatory Affairs Associates Regulatory Affairs Assistance Regulatory Affairs head/ Director Medical Information Associates Drug Inspector/Drug Controller Drug Safety Specialist/ Regulatory Food Safety Scientist Quality Operations/Quality Control/Quality Assurance Regulatory Affairs Consultants

Thank you

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