Pharmacovigilance Course in India

Jan. 12, 2013 - PRLog -- Courses in Pharmacovigilance at IBRI Noida

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

1. Certificate Program in Pharmacovigilance

Course Papers:

Paper-I: Principles of Pharmacovigilance

Paper -II: Methodologies in Pharmacovigilance and Signal Detection

Paper -III: Pharmacovigilance Compliance and Management

Paper -IV: Pharmacovigilance Regulations and Guidelines

Mode of Education: Distance Mode

Course Duration: 6 Months

Eligibility: Any Science Graduate

Course Fees: Rs 7000/- which can be paid by DD or Cheque in favour of “IBRI-Unit of Exordior Technical Services Pvt Ltd” payable at “Noida”.

2. Comprehensive program in Clinical trials Data Management and Pharmacovigilance

Course Papers:

Paper-I: Introduction to Clinical Trials

Paper-II: Introduction to Clinical Trials Data Management

Paper-III: Principles of Pharmacovigilance

Paper-IV: Biostatistics, SAS and Data Management

Paper-V: Computerized Systems for E- Case Report Form and Data Acquisition and Validation

Paper-VI: Methodologies in Pharmacovigilance and Signal Detection

Paper-VII: GCP, ICH, Ethics, IRB, Regulations for Clinical Trials

Paper-VIII: Pharmacovigilance Compliance and Management

Mode of Education: Distance Mode

Course Duration: 12 Months

Eligibility: Any Science Graduate

Course Fees: Rs 14500/- which can be paid by DD or Cheque in favour of “IBRI-Unit of Exordior Technical Services Pvt Ltd” payable at “Noida”.