Pharmacovigilance Pharma 7th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective V) detail syllabus for Pharmacy (Pharma), 2017 regulation is collected from the Anna Univ official website and presented for students of Anna University. The details of the course are: course code (PY8017), Category (PE), Contact Periods/week (3), Teaching hours/week (3), Practical Hours/week (0). The total course credits are given in combined syllabus.
For all other pharma 7th sem syllabus for b.tech 2017 regulation anna univ you can visit Pharma 7th Sem syllabus for B.Tech 2017 regulation Anna Univ Subjects. For all other Professional Elective V subjects do refer to Professional Elective V. The detail syllabus for pharmacovigilance is as follows.
Course Objective:
- The course intends to provide knowledge about development and global scenario of pharmacovigilance and establishment of pharmacovigilance programme in an organization
- To develops the skills of classifying drugs, diseases and adverse drug reactions.
Unit I
For complete syllabus and results, class timetable and more pls download iStudy. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.
Unit II
Sources of Data
Anatomical, therapeutic and chemical classification of drugs – International classification of diseases -Daily defined doses – International Nonproprietary Names for drugs – Drug dictionaries and coding in pharmacovigilance – WHO adverse reaction terminologies – MedDRA and StandardisedMedDRA queries – WHO drug dictionary – Eudravigilance medicinal product dictionary Information resources in pharmacovigilance – Basic drug information resources -Specialised resources for ADRs Establishing pharmacovigilance programme – Pre-clinical studies-Human volunteer studies – Clinical trials – Post-marketing surveillance – Systematic reviews and meta-analysis –
Unit III
Pharmacovigilance Methods
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. Communication in pharmacovigilance – Effective communication in Pharmacovigilance -Communication in Drug Safety Crisis management – Communicating with Regulatory Agencies, Business Partners, Healthcare facilities and Media.
Unit IV
For complete syllabus and results, class timetable and more pls download iStudy. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.
Unit V
Pharmacogenomics of Adverse Drug Reactions
Drug safety evaluation in special population – Pediatrics – Pregnancy and lactation – Geriatrics. CIOMS – CIOMS Working Groups – CIOMS Form. CDSCO (India) and Pharmacovigilance – D&C Act and Schedule Y – Differences in Indian and global pharmacovigilance requirements
Course Outcome:
At the completion of course, the student will be able
- To report adverse drug reaction in proper format.
- To analyze and compare the data generated during pharmacovigilance study
- To manage and adhere with regulatory requirements of different country.
Text Books:
- SumitVerma, S and Gulati, Y. Fundamentals of Pharmacovigilance, Paras Medical Publishers, 2017
- Gupta, S. K. Text book of Pharmacovigilance, Jaypee Brothers Medical Publishers, 2011.
- Mohanta, G.P and Manna, P.K. A Textbook of Pharmacovigilance: Concept and Practice, PharmaMed Press, 2015.
References:
- Andrews, E.B and Moore, N. Manns Pharmacovigilance, Wiley-Blackwel, 3rd Edition, 2014.
- Waller, P and Harrison iWoolrych, M. An Introduction to Pharmacovigilance, Wiley-Blackwel, 2nd Edition, 2017
- Orleans-Lindsay, J. Pharmacovigilance Medical Writing: A Good Practice Guide, Wiley-Blackwell, 2012.
For detail syllabus of all other subjects of B.Tech Pharma, 2017 regulation do visit Pharma 7th Sem syllabus for 2017 Regulation.
Dont forget to download iStudy for latest syllabus and results, class timetable and more.