BP805ET: Pharmacovigilance – Theory Syllabus for B.Pharm 8th Sem 2019 Pattern Mumbai University

Pharmacovigilance – Theory detailed Syllabus Scheme for Bachelor of Pharmacy (B.Pharm), 2019 regulation has been taken from the University of Mumbai official website and presented for the Pharmacy students. For Course Code, Subject Name, Continuous Mode, SE Marks, SE Duration, Total, Marks, Duration in Hours, Total Marks, and other information, do visit full semester subjects post given below.

For all other Mumbai University B.Pharm 8th Sem Syllabus 2019 Pattern, do visit B.Pharm 8th Sem 2019 Pattern Scheme. The detailed syllabus scheme for pharmacovigilance – theory is as follows.

BP805ET: Pharmacovigilance – Theory Syllabus for B.Pharm 8th Sem 2019 Pattern Mumbai University

Scope:

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Objectives

At completion of this paper it is expected that students will be able to (know, do, and appreciate):

1. Why drug safety monitoring is important?
2. History and development of pharmacovigilance
3. National and international scenario of pharmacovigilance
4. Dictionaries, coding and terminologies used in pharmacovigilance
5. Detection of new adverse drug reactions and their assessment
6. International standards for classification of diseases and drugs
7. Adverse drug reaction reporting systems and communication in pharmacovigilance
8. Methods to generate safety data during preclinical, clinical and post approval phases of drugs life cycle
9. Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation
10. Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India
11. ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning
12. CIOMS requirements for ADR reporting
13. Writing case narratives of adverse events and their quality.

UNIT I 10

1. Introduction to Pharmacovigilance
   • History and development of Pharmacovigilance
   • Importance of safety monitoring of Medicine
   • WHO international drug monitoring programme
   • Pharmacovigilance Program of India(PvPI) 4
2. Introduction to adverse drug reactions
   • Definitions and classification of ADRs
   • Detection and reporting
   • Methods in Causality assessment
   • Severity and seriousness assessment
   • Predictability and preventability assessment 4
   • Management of adverse drug reactions
3. Basic terminologies used in pharmacovigilance
   • Terminologies of adverse medication related events
   • Regulatory terminologies 2

UNIT -II 10

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UNIT -III 10

1. Vaccine safety surveillance
   • Vaccine Pharmacovigilance
   • Vaccination failure
   • Adverse events following immunization 3
2. Pharmacovigilance methods
   • Passive surveillance – Spontaneous reports and case series
   • Stimulated reporting
   • Active surveillance – Sentinel sites, drug event monitoring and registries
   • Comparative observational studies – Cross sectional study, case control study and cohort study
   • Targeted clinical investigations 5
3. Communication in pharmacovigilance
   • Effective communication in Pharmacovigilance
   • Communication in Drug Safety Crisis management
   • Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media 2

UNIT -IV 8

1. Statistical methods for evaluating medication safety data Safety data generation
   • Preclinical phase
   • Clinical phase
   • Post approval phase 3
2. ICH Guidelines for Pharmacovigilance
   • Organization and objectives of ICH
   • Expedited reporting
   • Individual case safety reports
   • Periodic safety update reports
   • Post approval expedited reporting
   • Pharmacovigilance planning
   • Good clinical practice in pharmacovigilance studies 5

Unit V 7

For the complete Syllabus, results, class timetable, and many other features kindly download the iStudy App
It is a lightweight, easy to use, no images, and no pdf platform to make students’s lives easier.
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Recommended Books (Latest edition):

1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.
2. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and Bartlett Publishers.
3. Mann’s Pharmacovigilance:Elizabeth B. Andrews, Nicholas, Wiley Publishers.
4. Stephens’ Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley Publishers.
5. An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers.
6. Cobert’s Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones& Bartlett Publishers.
7. Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel, Sean Hennessy,Wiley Publishers.
8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G. Parthasarathi, Karin NyfortHansen,Milap C. Nahata
9. National Formulary of India
10. Text Book of Medicine by Yashpal Munjal
11. Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK Manna
12. http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn3=7297
13. http://www.ich.org/
14. http://www.cioms.ch/
15. http://cdsco.nic.in/
16. http://www.who.int/vaccine_safety/en/
17. http://www.ipc.gov.in/PvPI/pv_home.html

For detail syllabus of all other subjects of Bachelor of Pharmacy (B.Pharm), 2019 regulation do visit B.Pharm 8th Sem Subjects syllabus for 2019 regulation.