Certificate Program in Drug Regulatory Affairs (CPDRA)

DRUG REGULATORY AFFAIRS (DRA) OVERVIEW

Regulatory Affairs is a comparatively Young, multidimensional  and growing profession in the Pharmaceutical field with a desire to protect public health, by assuring safety and efficacy of pharmaceuticals products, veterinary medicines, medical devices, pesticides, agrochemicals, orphan drugs, cosmetics and complementary medicines. Regulatory Affairs professionals come from a variety of disciplines such as law, academics, industrial research and medicine.

According to the Regulatory Affairs Professional Society (RAPS), RA professionals are in increasing demand. Subsequently, the compensation package for careers in different level in this arena is also growing. The U.S. Department of Labor anticipates 24% growth, much higher than the national average of 9%. They report that "employment is expected to increase through 2016" and that "pharmaceutical and medicine manufacturing will be one of the fastest growing industries."

As outsourcing of jobs to India is high, the regulatory affairs industry in India is poised for rapid growth which is associated with flamboyant salaries. There are 120+ pharma companies having structured regulatory affairs department in India. Due to entry of MNCs in India, it is expected a requirement of 30,000 competent and trained workforce in next 5 years.

LEARNING OBJECTIVES

  • To impart clear understanding on various essential elements of Drug Regulatory Affairs
  • To provide theoretical knowledge on various essential DRA topics: Regulatory Introduction and Authorities,Regulatory Requirments, ICH Guidelines etc.
  • Roles and Responsibilities of DRA personnel along with its application required to execute at various levels.

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Curriculum

  • Introduction to Regulatory Affairs (Definition, Evolution, Scope, Role of DRA)
  • Regulatory Authorities (USFDA, Canadian, EU, CDSCO, ICH, WHO)
  • Regulatory Requirements in Pharmaceutical (Drug Product Lifecycle – Development, Regulatory Submission, Regulatory Compliance etc.)
  • Medical Device Regulation (Definition and Classification, Steps in Development, Product Lifecycle)
  • Overview of ICH Guidelines (Stability Testing of New Drug Substances and Products, Stability Testing : Photostability Testing of New Drug Substances and Products, Stability Testing for New Dosage Forms, Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, Evaluation of Stability Data, Stability Data Package for Registration Applications in Climatic Zones III and IV, Analytical Validation, Impurities Guidelines, Specifications Guidelines, Good Manufacturing practice Guidelines)

Eligibility

  • Pharmacy Students (Pursuing or completed): B.Pharm, M.Pharm
  • Life-Sciences Students (Pursuing or completed): B.Sc, M.Sc
  • Medicine Students (Pursuing or completed): BDS, MDS, MBBS. M.D., M.S, MCh
  • Alternative Medicine (Pursuing or completed): Ayurveda, Unani, Yoga, Siddhi, Homeopathy, Traditional Medicine etc.
  • Nursing (Pursuing or completed): B.Sc., M.Sc.
  • Industry Personnel
  • Clinical Research Personnel: CRC, CRA, CTA, Clinical Trial Investigators
  • PhD

Online Enrollment Procedure

Step 1

Click button Enroll Online and then Click Checkout button

Step 2

Complete and submit the Registration Form, followed by Checkout button

Step 3

Choose convenient Mode of Payment and Make the Payment

Step 4

Get Instant Access* to Login Details along with Study Material & Assignment.

*Instant access is applicable only to participant who have selected online mode of learning. For offline (distance) mode of learning, the study material and assignment will be dispatched to their corresponding address on the last date of registration of that batch.



Offline Enrollment Procedure

Step 1

Download the Offline Enrollment Form present on respective pages of courses

Step 2

Send the completed enrollment form along with the fee (details mentioned on enrollment form) on our official address

Step 3

Dispatch of course material along with assignment on your corresponding address.

Course FAQs

What is Drug Regulatory Affairs (DRA)?

Regulatory affairs is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

What are the career opportunities after completing CPDRA Training?

After successful completion of CPDRA one can start career as:

Drug Regulatory Associate/ Drug Regulatory Executive.

Why should I pursue this course?

CPDRA will offer you following inherent advantages to excel your career growth by:

  • Providing an in-depth knowledge in Drug Regulatory Affaris and its essential elements.
  • Increasing the visibility of your CV among potential recruiters
  • Increase the acceptance in companies’ for jobs against non CPDRA candidates.
  • An opportunity to explore career in clinical research domain as Drug Regultory Associate/ Executive

Where I can apply after completing CPDRA course?

After successfully completing CPDRA course one can join as Regulatory Associate with Pharmaceuticals, Biotech, Device, CROs, SMOs, Clinical Trial Consulting, Cosmetics, Local Regulatory Body (FDA, MHRA), Ministry of Health, In-vitro Diagnostics  companies etc.

What are the placement opportunities after completing CPDRA course?

Please visit General FAQs or visit Placement Assistance Page.

For more details on courses, fees, enrollment, Result, Assignments, Certificates, Placements visit our General FAQs section.

Course Code : SC-101-07
Level : Beginner
Mode of Learning : Online/ Distance
Registration Status : Open
Examination : Assignment Based
Fee : Rs. 10500
Current Batch : May'16 (Till 31st)
Duration : 24 weeks

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