Certificate Program in Drug Regulatory Affairs

DMF, Dossier, CTD, eCTD, Clinical Regulatory Affairs, Quality Assurance and Control
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Regulatory Affairs
Pharma Regulatory Affairs


Noida - Uttar Pradesh - India


NOIDA, India - May 22, 2014 - PRLog -- Program Objectives

This course will help you to understand the fundamental and concepts of regulation prevailing in various countries. It will enhance their knowledge and skills in the field of Regulatory Affairs. The objectives of the course are:

• To create experts in the field of RA documentation and research.
• To encourage continuous learning and development in RA field.
• To update knowledge of existing RA professionals.
Career in Regulatory Affairs
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. The pharmaceutical industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products.

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
Course Methodology
After the Enrollment the student will be provided study material in form of books, power points i.e. Introduction Kit is delivered to participants of the program – this kit will contain study material and all necessary information about the program with important dates.

Evaluation will be examination/assignment based.

Successful participants will be awarded ‘Certificates and Mark-Sheet in the respective areas by Distance participation along with the grade obtained.

For More Details about the Course Contact to:

Centre Manager

C-50, First Floor, Sec-2, NOIDA
Mob: +91-9999 509892 (For Registration and Enrollment)
Tel: +91(120)412 2315 , Email: info@ibri.org.in

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Tags:Regulatory Affairs, Pharma Regulatory Affairs
Location:Noida - Uttar Pradesh - India
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