BP 805T: PHARMACOVIGILANCE (Theory)

45 hours

Scope: This paper will provide an opportunity for the student to learn about development of
pharmacovigilance as a science, basic terminologies used in pharmacovigilance, global scenario
of Pharmacovigilance, train students on establishing pharmacovigilance programme in an
organization, various methods that can be used to generate safety data and signal detection. This
paper also develops the skills of classifying drugs, diseases and adverse drug reactions.

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
4.
and international scenario of pharmacovigilance
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 pre clinical, clinical and post approval phases of
drugs' life cycle
9. Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation
10. Pharmacovigilance Program of India (PVPID requirement for ADR reporting in India
I1. 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.

Course Content

Unit I 10 Hours
Introduction to Pharmacovigilance
History and development of Pharmacovigilance
Importance of safety monitoring of Medicine
WHO international drug monitoring programme
Pharmacovigilance Program of India(PvP)
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
Manage ment of adverse drug reactions
Basic terminologies used in pharmacovigilance

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 Terminologies of adverse medication related events
Regulatory terminologies
Unit 10 hours
Drug and disease classification
Anatomical, therapeutic and chemical classification of drugs
International classification of diseases
Daily defined doses
International Non proprietary Names for drugs
Drug dictionaries and coding in pharmacovigilance
WHO adverse reaction terminologies
MedDRA and Standardised MedDRA queries
WHO drug dictionary
Eudravigilance medicinal product dictionary
Information resources in pharmacovigilance
Basic drug information resources
Specialised resources for ADRs
Establishing pharmacovigilance programme
Establishing in a hospital
Establishment & operation of drug safety department in industry
Contract Research Organisations (CROs)
Establishing a national programme

Unit Il1 10 Hours

Vaccine safety surveillance
Vaccine Pharmacovigilance
Vaccination failure
Adverse events following immunization
Pharmacovigilance methods
Passive surveillance - Spontaneous reports and case series

Stimulated reporting
Active surveillance - Sentinel sites, drug event monitoring and registries

Comparati ve 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 &
Media

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Unit IV 81Hours

Safety data generation

P r e clinical phase
Clinical phase
Post approval phase (PMS)
ICH Guidelines for Phammacovigilance
Organization and objectives of ICH

Expedited reporing
Individual case safety reports
Periodic safety update reports
Post approval expedited reporting
Pharmacovigilance planning
Good clinical practice in pharmacovigilance studies

Unit V 7 hours
Pharmacogenomies of adverse drug reactions
Genetics related ADR with example focusing PK parameters.
Drug safety evaluation in special population
Paediatrics
Pregnancy and lactation
Geriatrics
CIOMS
CIOMS Working Groups
CIOMS Form
CDSCO (Indin) and Pharmacovigilance
D&C Act and Schedule Y
Differences in Indian and global pharmacovigilance requirements

Recommended Books (Latest edition):

. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.
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
 BP804 ET: PHARMACEUTICAL REGULATORY SCIENCE (Theory)

45Hours

Scope: This course is designed to impart the fundamental knowledge on the regulatory
requirements for approval of new drugs, and drug products in regulated markets of
India & other countries like US, EU, Japan, Australia,UK etc. It prepares the students
to learn in detail on the regulatory requirements, documentation requirements, and
registration procedures for marketing the drug products.

Objectives: Upon completion of the subject student shall be able to;

1. Know about the process of drug discovery and development
2. Know the regulatory authorities and agencies governing the manufacture and sale
of pharmaceuticals
3. Know the regulatory approval process and their registration in Indian and
international markets

Course content:

Unit I 10Hours
New Drug Discovery and development
Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical
activities, clinical studies, Innovator and generics, Concept of generics, Generic drug
product development.
Unit I 10Hours

Regulatory Approval Process

Approval processes and timelines involved in Investigational New Drug (IND), New
Drug Application (NDA), Abbreviated New Dug Application (ANDA). Changes to an
approved NDA / ANDA.

Regulatory authorities and agencies

Overview of regulatory authorities of India, United States, European Union, Australia,
Japan, Canada (Organization structure and types of applications)

Unit II 10Hours

Registration of Indian drug product in overseas market

Procedure for export of pharmaceutical products, Technical documentation, Drug Master
Files (DMF), Common Technical Document (CTD), electronic Common Technical

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Document (eCTD), ASEAN Common Technical Document (ACTD)research.

Unit IV 08Hours
Clinical trials
Developing clinical trial protocols, Institutional Review Board / Independent Ethics
committee formation and working procedures, Informed consent process and
procedures, GCP obligations of Investigators, sponsors & Monitors, Managing and
Monitoring clinical trials, Pharmacovigilance - safety monitoring in clinical trials

Unit V 07Hours

Regulatory Concepts
Basic terminology. guidance, guidelines, regulations, Laws and Acts, Orange book,
Federal Register, Code of Federal Regulatory, Purple book

Recommended books (Latest edition):

1. Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.
2. The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and
Robert P. Martin, Drugs and the Pharmaceutical Sciences,Vol. 185. Informa Health
care Publishers
3. New Drug Approval Process: Accelerating Global Registrations By Richard A
Guarino, MD, 5" edition, Drugs and the Pharmaceutical Sciences,Vol.190.
4. Guidebook for drug regulatory submissions/Sandy Weinberg. By John Wiley &
Sons. Inc.
5. FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and
biologics /edited by Douglas J. Pisano, David Mantus
Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and
Isader Kaufer, Marcel Dekker series, Vol. 143
7. Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance
By Fay A. Rozovsky and Rodney K. Adams
8. Principles and Practices of Clinical Research, Second Edition Edited by John I.
Gallin and Frederick P. Ognibene
9. Drugs: From Discovery to Approval, Second Edition By Rick Ng
 BP 802T SoCIAL AND PREVENTIVE PHARMACY

Hours: 45

Scope:
The purpose of this course is to introduce to students a number of health issues and their
challenges. This course also introduced a number of national health programmes. The
roles of the pharmacist in these contexts are also discussed.

Objectives:
After the successful completion of this course, the student shall be able to:
Acquire high consciousness/realization of current issuesrelated to health and
pharmaceutical problems within the country and worldwide.
Have a critical way of thinking based on current healthcare development.
Evaluate alternative ways of solving problems related tohealth and
pharmaceutical issues
Course content:

Unit I: 10 Hours
Concept of health and disease: Definition, concepts and evaluation of public health.
Understanding the concept of prevention and control of disease, social causes of diseases
and social problems of the sick.

Social and health education: Food in relation to nutrition and health, Balanced diet,
Nutritional deficiencies, Vitamin deficiencies, Malnutrition and its prevention.

Sociology and health: Socio cultural factors related to health and disease, Impact of
urbanization on health and disease, Poverty and health

Hygiene and health: personal hygiene and health care; avoidable habits

Unit I1: 10 Hours

Preventive medicine: General principles of prevention and control of diseases such as
cholera, SARS, Ebola virus, influenza, acute respiratory infections, malaria, chicken
guinea, dengue, lymphatic filariasis, pneumonia, hypertension, diabetes mellitus, cancer,
drug addiction-drug substance abuse

Unit Il1: 10 Hours

National health programs, its objectives, functioning and outcome of the following:
HIV AND AIDS control programme, TB, Integrated disease surveillance program
(IDSP). National leprosy control programme, National mental health program, National

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programme for prevention and control of deafness, Universal immunization programme,
National programme for control of blindness, Pulse polio programme.

Unit IV: 08 Hours

National health intervention programme for mother and child, National family welfare
programme, National tobacco control programme, National Malaria Prevention Program,
National programme for the health care for the elderly, Social health programme; role of
WHO in Indian national program

Unit V: 07 Hours
Community services in rural, urban and school health: Functions of PHC, Improvement
in rural sanitation, national urban health mission, Health promotion and education in
school.

Recommended Books (Latest edition):

1. Short Textbook of Preventive and Social Medicine, Prabhakara GN, 2 Edition,

2010, ISBN: 9789380704104, JAYPEE Publications
2. Textbook of Preventive and Social Medicine (Mahajan and Gupta),. Edited by Roy
Rabindra Nath, Saha Indranil, 4th Edition, 2013, ISBN: 9789350901878, JAYPEE
Publications
Review of Preventive and Social Medicine (Including Biostatistics), Jain Vivek, 6"
Edition, 2014, ISBN: 978935 1522331, JAYPEE Publications
4. Essentials of Community Medicine-A Practical Approach, Hiremath Lalita D,
Hiremath Dhananjaya A, 2nd Edition, 2012, ISBN: 9789350250440, JAYPEE
Publications
Park Textbook of Preventive and Social Medicine, K Park, 21 Edition, 2011.
ISBN-14:9788190128285, BANARSIDAS BHANOTPUBLISHERS.
6. Community Pharmacy Practice, Ramesh Adepu, BSP publishers, Hyderabad

Recommended Journals:

1. Research in Social and Administrative Pharmacy, Elsevier, Ireland

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 BP801T. BIOSTATISITCS AND RESEARCH METHODOLOGY (Theory)

45 Hours

Scope: To understand the applications of Biostatics in Pharmacy. This subject deals with
descriptive statistics, Graphics, Correlation, Regression, logistic regression Probability
theory, Sampling technique, Parametric tests, Non Parametric tests, ANOVA,
Introduction to Design of Experiments, Phases of Clinical trials and Observational and
Experimental studies, SPSS, R and MINITAB statistical software's, analyzing the
statistical data using Excel.

Objectives: Upon completion of the course the student shall be able to

Know the operation of M.S. Excel, SPSS, R and MINITAB", DoE (Design of
Experiment)
Know the various statistical techniques to solve statistical problems
Appreciate statistical techniques in solving the problems.

Course content:
Unit-I 10 Hours
Introduction: Statistics, Biostatistics, Frequency distribution
Measures of central tendency: Mean, Median, Mode- Pharmaceutical examples
Measures of dispersion: Dispersion, Range, standard deviation, Pharmaceutical
problems
Correlation: Definition, Karl Pearson's coefficient of correlation, Multiple correlation
Pharmaceuticals examples

Unit-I 10 Hours
Regression: Curve fitting by the method of least squares, fitting the lines y= a + bx and x
= a+ by, Multiple regression, standard error of regression- Pharmaceutical Examples
Probability:Definition of probability, Binomial distribution, Normal distribution,
Poisson's distribution, properties problems
Sample, Population, large sample, small sample, Null hypothesis, alternative hypothesis,
sampling, essence of sampling, types of sampling, Error-I type, Error-II type, Standard
error of mean (SEM) - Pharmaceutical examples

Parametric test: t-test(Sample, Pooled or Unpaired and Paired) , ANOVA, (One way
and Two way), Least Significance difference

Unit-III 10 Hours
Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, Kruskal-Wallis
test, Friedman Test

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Introduction to Research: Need for research, Need for design of Experiments,
Experiential Design Technique, plagiarism
Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter Plot graph
Designing the methodology: Sample size determination and Power of a study, Report
writing and presentation of data, Protocol, Cohorts studies, Observational studies,
Experimental studies, Designing clinical trial, various phases.

Unit-IV 8 Hours
Blocking and confounding system for Two-level factorials
Regression modeling: Hypothesis testing in Simple and Multiple regressionmodels
Introduction to Practical components of Industrial and Clinical Trials Problems:
Statistical Analysis Using Excel, SPSS, MINITAB", DESIGN OF EXPERIMENTS, R-
Online Statistical Software's to Industrial and Clinical trial approach

Unit-V 7Hours
Design and Analysis of experiments:
Factorial Design: Definition, 2, 2'design. Advantage of factorial design
Response Surface methodology: Central composite design, Historical design.
Optimization Techniques

Recommended Books (Latest edition):

1. Pharmaceutical statistics- Practical and clinical applications, Sanford Bolton,

publisher Marcel Dekker Inc. NewYork.
2. Fundamental of Statistics - Himalaya Publishing House- S.c.Guptha

3. Design and Analysis of Experiments -PHI Learning Private Limited, R.

Pannerselvam,
4. Design and Analysis of Experiments Wiley Students Edition,
Douglas and C. Montgomery

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