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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:
Course Fees: Rs 7000/- which can be paid by DD or Cheque in favour of “Indian Biosciences and research Institute” 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:
Course Fees: Rs 14500/- which can be paid by DD or Cheque in favour of “Indian Biosciences and research Institute” payable at “Noida”.
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