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Pharmacovigilance:Classroom

Pharmacovigilance:Classroom (Full time),Class room weekend, Internships Programmes, Workshops

Course Overview

Pharmacovigilance is a scientific discipline which mainly pertains with identifying, validating, quantifying, evaluating and minimizing the adverse effects of therapeutic drugs, devices or biologics in order to increase their safety. The clinical research regulatory agencies worldwide including US FDA, Indian DCGI and EMEA etc., are strengthening the safety laws for adoption of a systematic pharmacovigilance framework. The adverse event data generated by clinical trials worldwide is enormous and has led to the outsourcing of the pharmacovigilance and pharmacoepidemilogy services of the pharma-biotech Research and Development. This fact is compounded by the increasing number of local clinical trials has led to a spurt in the pharmacovigilance job market in India.


IBRI offers a wide range of programmes in Pharmacovigilance


  • Global Pharmacovigilance - Case Processing - ICSRs; Aggregate Reporting; Risk Management & Signal Detection; Pharmacovigilance Audits & Inspections; Pharmacovigilance Regulatory; Medical Review, Safety Databases and many more areas
  • Clinical Research / Clinical Trials - Clinical Trials Management; GCP Training; Investigator Training, CRA - Clinical Research Associate, CRC - Clinical Research Coordinator and over 30 modules in clinical research
  • Medical and Scientific Writing
  • Drug / Pharma Regulatory Affairs

As Pharmacovigilance and Clinical Research are becoming an important part of drug development as it deals with the patient’s safety keeping this in mind IBRI has introduced certificate course in Pharmcovigilance.


S.No Courses
I Post Graduate Diploma in Pharmacovigilance -3 months
II Advanced PG Diploma in Pharmacovigilance- 6 months
III Advanced Post Graduate Diploma in Pharmacovigilance Audits and Inspections- 3 Months
IV Certificate Programmes in Clinical Trials Regulations GCP in Europe and U.S- 2 months
V Certificate Programme in Signal detection and Risk Management- 3 months
VI Certificate Programme in medical Review- 3 months
VII ICH GCP Certificate Programme in clinical research- 3 months
Paper:IV Pharmacovigilance Reporting Systems and Tools for Management of Reports

    Eligibility

    Graduates in Pharmacy and Bio-Sciences, Medical Professionals, i.e Doctors of all disciplines, junior professionals in Pharmaceutical and IT Industry, Clinical Research professionals/Appearing Students.

    Career in clinical Research

    Career in Clinical Research based on the qualification of Individual

    • Doctors - Principal Investigator, Co-Investigator, Medical Advisor, Drug Developers,Regulatory Affairs Manager, Clinical Research Physician.

    • Pharmacists, Life Science graduates, Science postgraduates in Biochemistry -Site Coordinator, Clinical Research Associate, Medical writers,Clinical Research Manager and Drug Development Associate, Biostatistician, Quality assurance.

    • IT professionals, Biostatistician, Engineers, postgraduates in Maths, Applied Maths, operational Research, Statistics - Clinical Data Manager, Drug Development Associate.

    • Management Graduates (MBA)-Business Development, Clinical Project Management,Clinical Research Management, Regulatory Affair Management.

Fees:
Registration Fees: Rs.1000/- Only

Rs.60,000/- Only(One time payment) (Fees can also paid in three installments i.e. Rs.21, 000/ for each installment.

Note:

1-Exam fees are excluded from Course fees.

2-Payment is to be made through Cash / Demand Draft / At Par Cheque in favor of "IBRI-UNIT OF EXORDIOR TECHNICAL SERVICES PRIVATE LIMITED" payable at "NOIDA".