Dual Certification in Clinical Research and Pharmacovigilance (DCCRPV)

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.

The Pharmacovigilance market is expected to reach US$ 2253 by 2015 where India is expected to play a significant role. As India is presently the fourth largest producer of pharmaceuticals with more than 6,000 licensed drug manufacturers and over 60,000 branded formulations. This need has resulted in setting up National Pharmacovigilance Program and companies in India offering a huge opportunity for candidates from healthcare sciences to enhance their career in this field.

LEARNING OBJECTIVES

  • To impart clear and deep understanding on various essential elements of Clinical Research and Pharmacovigilance
  • To provide theoretical knowledge on various essential PV topics: Terminologies, Guidelines, Reporting Requirements, Signal Detection 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 pharmacovigilance: SAE Reporting and form, PSUR, ISCRs, MedDRA 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 PV 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: Pharmacovigilance

  • Introduction to Pharmacovigilance
  • Pharmacovigilance Terminology
  • Global Perspective of Pharmacovigilance and Adverse Drug Reaction (ADR) Reporting
  • Guidelines and Standards Governing Pharmacovigilance
  • Global AE Reporting System and Reporting Forms
  • Individual Case Safety Reports (ICSRs)
  • Public Safety Update Reports (PSURs)
  • Signal Detection
  • Medical Dictionary For Drug Regulatory Activities (MedDRA)
  • Expedited Reporting And Requirements

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 Pharmacovigilance?

Pharmacovigilance is the pharmacological sciences relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of the therapeutic drugs, devices and biologics. Setting up of stringent laws by regulatory bodies (e.g. US-FDA, DCGI, EMEA etc.) has led to the adoption of a systematic Pharmacovigilance framework worldwide. This in turn had led to the creation of large number of jobs pertaining to this field.

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 the career growth in Pharmacovigilance industry after completing DCCRPV Training?

The career growth in PV industry is as follows:

Pharmacovigilance Associate (PVA) >> Drug Safety Associate>> Sr. Drug Safety Associate >> Aggregate Report Scientist >> Subject Matter Expert

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

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

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

Where I can apply after completing DCCRPV course?

After successfully completing DCCRPV course one can join industry as:

Pharmacovigilance Associate (PVA) with Sponsor Companies (Pharmaceuticals, Biotech, Research), IT companies, CROs, Hospitals, PV Centers, SMOs, KPOs etc.

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.

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

Course Code : DC-201-02
Level : Beginner
Mode of Learning : Online/ Distance
Registration Status : Open
Examination : Assignment Based
Fee : Rs. 13500
Current Batch : May'16 (Till 31st)
Duration : 24 weeks

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