Post graduation diploma in Pharmacovigilance

Raaj GPRAC
Distance

Rs 15,000
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Important information

  • Post Graduate Diploma
  • Distance learning
  • Duration:
    3 Months
  • When:
    Flexible
  • Credits:
  • Delivery of study materials
Description

1) Introduction and Objectives of Pharmacovigilance
Brief history of Pharmacovigilance in India, Objectives of Pharmacovigilance
2)Contents of Pharmacovigilance
Classification of ADR, Types of ADRs, Mechanism, The importance of reporting ADR, Post-marketing surveillance (PMS)
3)ICH Guidelines
Quality Guidelines, Safety Guidelines, Efficacy Guidelines & Multidisciplinary Guidelines
4)Pharmacovigilance Methods
Passive Surveillance Stimulated Reporting Drug Event Monitoring Drug Utilization Study
5)Wings of Pharmacovigilance
The WHO Quality Assurance and Safety: Medicines Team,Uppsala Monitoring Centre, National Pharmacovigilance Centers
6)Role of Pharmacovigilance
Pharmacovigilance in Drug Regulation, Clinical trial regulation, Risk and Crisis management, Pharmacovigilance in Clinical Practice
7)Scope of Pharmacovigilance
Major challenges of Pharmacovigilance: & Globalization
8)Signal Detection and Signal Analysis
SAS & Signal Detection: Features, Functionality & Architecture
9)Good Pharmacovigilance Practices
Types of Inspections, Inspection report, and Company response Process grading of inspection findings
10)Periodic Safety Updates Reports
General principles Generic products Software Used For Pharmacovigilance Tools and technologies for Pharmacovigilance
11)European PV
EVMPD & XEVMPD

Important information
Venues

Where and when

Starts Location Timetable
Flexible
Distance learning

Frequent Asked Questions

· What are the objectives of this course?

To create a nation-wide system for patient safety reporting. To provide Principles of medical diagnosis. Comprehensive and up-to-date understanding of medical and scientific aspects of ADRs. Identifying the latest regulatory framework for pharmacovigilance. Implication for safety reporting in global clinical trials. Risk management plans/ Risk benefit determination. To identify & analyse the new signal (ADR) from the reported cases. To analyse the benefit risk ratio of marketed medications. To generate evidence based information on safety of medicines. To support the regulatory agencies in the decision making process on use of medicines. To communicate the safety information on use of medicines to minimize the risk. To emerge as a national centre of excellence for pharmacovigilance activities. To collaborate with other national centres for the exchange of information & data management. To provide training & consultancy support to other national pharmacovigilance centers located across globe. Overview of ADRs and interactions ADRs by body system: Cardiovascular, Dermatological, Neurological, Psychiatric, Renal, Respiratory, plus Teratology and To knows about issues in Pregnancy To understand Pharmacogenetic and metabolic basis of ADRs Immunological aspects of ADRs

· Who is it intended for?

Graduate/Post graduate in Science, Pharmacy, and Medicines. Drug Safety / Pharmacovigilance Staff. Regulatory Affairs Staff. Clinical Development Staff. Clinical Research Organization Staff. Anyone wishing to build or update their knowledge on adverse event, reporting and drug safety information. Clinicians and academic staff. Pharmacists or other professions allied to medicine.

What you'll learn on the course

PSUR
ADR

Teachers and trainers (1)

Rajashri Ojha
Rajashri Ojha
Teacher

Course programme

1) Introduction and Objectives of PharmacovigilanceBrief history of Pharmacovigilance in India, Objectives of Pharmacovigilance2)Contents of PharmacovigilanceClassification of ADR, Types of ADRs, Mechanism, The importance of reporting ADR, Post-marketing surveillance (PMS)3)ICH GuidelinesQuality Guidelines, Safety Guidelines, Efficacy Guidelines & Multidisciplinary Guidelines4)Pharmacovigilance MethodsPassive Surveillance Stimulated Reporting Drug Event Monitoring Drug Utilization Study5)Wings of PharmacovigilanceThe WHO Quality Assurance and Safety: Medicines Team,Uppsala Monitoring Centre, National Pharmacovigilance Centers6)Role of PharmacovigilancePharmacovigilance in Drug Regulation, Clinical trial regulation, Risk and Crisis management, Pharmacovigilance in Clinical Practice7)Scope of PharmacovigilanceMajor challenges of Pharmacovigilance: & Globalization8)Signal Detection and Signal AnalysisSAS & Signal Detection: Features, Functionality & Architecture9)Good Pharmacovigilance PracticesTypes of Inspections, Inspection report, and Company response Process grading of inspection findings10)Periodic Safety Updates ReportsGeneral principles Generic products Software Used For Pharmacovigilance Tools and technologies for Pharmacovigilance11)European PVEVMPD & XEVMPD

Additional information

For further enquiries or Prospectus, write to or call us on: localhost, info@rajgprac.com , raajgprac@gmail.com, rajashrio@gmail.comwww.raajpharmaelearning.com,@mtnl.net.in Phone no: 9819488208 / 9821144706 / 022 65619030 /022 25445541

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