Dual Certification in Clinical Research and Drug Regulatory Affairs (DCCRDRA)

INDUSTRY OVERVIEW

Clinical Research industry has witnessed an exponential growth in past recent years. With more than 155000 clinical trials has been conducted all over the world till date resulting in development of new and better drug and therapies. This has resulted in setting up of Pharmacovigilance centers to detect access and prevent to long-term and short-term side effect from these drugs.

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 and deep understanding on various essential elements of Clinical Research and Drug Regulatory Affairs.
  • To provide theoretical knowledge on various essential DRA topics: Regulatory Introduction and Authorities,Regulatory Requirments, ICH Guidelines etc.
  • To provide theoretical knowledge on various essential CR topics: Drug Discovery, Regulatory, GCP, Ethics etc.
  • To train you on different aspects and activities performed during a clinical trial: Informed Consent, SAE Reporting etc.
  • Roles and Responsibilities of CR and DRA Personnel along with its application required to execute at various levels.

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Curriculum

Module1: Clinical Research

  • Introduction to Clinical Research
  • Ethics in Clinical Research
  • Roles & Responsibilities of Clinical Research Personnel
  • Guidelines & Regulation Associated with Clinical Research
  • Essential Clinical Trial document
  • Importance of Informed Consent Documentation
  • Importance Safety Reporting
  • Recent Trends in Clinical Research
  • Careers in Clinical research
  • Clinical Research Glossary & Common Abbreviation

Module 2: Drug Regulatory Affairs

  • 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 Clinical Research?

“Clinical research is a branch of medical science that determines the safety & effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use” or “We can say that clinical research is an important part of the drug/device discovery and development to ensure that the drug/device to be marketed is safe and effective on human usage”.
 

What is Drug Regulatory Affairs

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 is the career growth in DRA industry after completing this Training?

After successful completion of CPDRA one can start career as: Drug Regulatory Associate/ Drug Regulatory Executive.

What is the career growth in Clinical Research industry after completing this Training?

The career growth in CR industry is as follows:

Physicians:Principal Investigator, Co-investigator, Medical Advisor, Drug Developers, Regulatory Affairs Manager and Clinical Research Physician etc. 

Others:Clinical Research Coordinator (CRC)/ Clinical Research Associate (CRA) >> Sr. CRA >> Project Manager >> Team Leader >> Operations Manager >> Director

Why should I pursue this course?

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

  • providing an in-depth knowledge of Clinical Research and Drug Regulatory Affairs essential elements.
  • increasing the visibility of your CV among potential recruiters
  • Increase the acceptance in companies’ for jobs against non DCCRDRA candidates.
  • An excellent opportunity to explore career in two domains simultaneously as CRC/ CRA in clinical research or DRA Associate.

Where I can apply after completing DCCRDRA course?

After successfully completing this course one can join industry as:

Clinical Research: Clinical Research Associate/ Clinical Research Coordinator (CRC) with Sponsor Companies (Pharmaceuticals/ Biotech), Hospital Sites, Contract Research Organizations (CROs), Site Management Organizations (SMOs), Research Institutions etc.
 

Drug Regulatory Affairs: After successfully completing this 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.

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

Course Code : DC-201-05
Level : Beginner
Mode of Learning : Online/ Distance
Registration Status : Open
Examination : Assignment Based
Fee : Rs. 14500
Current Batch : May'16 (Till 31st)
Duration : 24 weeks

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