The Right Place At THE Right Time

Create your own future

Tell me about yourself?

Hi, Myself Sandeep Kumar, and I am from Varanasi. I have completed M.S Pharm in
Pharmacoinformatics from Niper Hajipur. My hobbies are playing Table Tennis and
riding Bike. Now coming to my family background, I have four sister and they are
living with my parents. My father is farmer and my mom is house maker.
Why do you want to work here?
Actually, I am looking for challenging and exciting environment in reputed company
like yours where I can get rewarding experience by enhancing my knowledge and skill
so that I can contribute myself to growth of the company as well as health care system,
so I think this will be best platform to proof myself.
What is your greatest strength?
I am very energetic and determinant candidate with positive attitude towards my carrier
and my life.
What is your weakness?
I am straightforward and sometime I get nervous while talking with new person.
What motivates you?
“I’ve always been motivated by desire to achieve.
Why should I hire you?
Because, as fresher, I have scientific knowledge in drug discovery programme like drug
designing software, data mining, literature survey, medical terminology scientific
writing skill which has direct connection to this field in which I will put all my efforts
which help to speed up further phase of clinical trial study which lead to growth of the
company and it has also potentially to reduce overall cost.(for the good progress of
organization)
What is your goal in future?
My short term goal is to get good challenging job in reputed company like yours and in
future I would like to get highly respected designation in that organization where I can
utilize my skill and experience to benefit the people and company as whole.
What are your salary requirements?
I am fresher, Salary is not first priority for me. This is a big platform to start my career
and also want to gain experience by improving my knowledge and skills. So I expect a
considerable of salary according to my ability and your company’s norms which will
fulfil my economical needs.

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  I except competitive salary which lined with my education and based on my
performance.
Why you want to change your field?
I have learnt a lot of things during my study and that is basic for any student. And as
we know that “Change is the law of nature” and some great people also told, “if you
want to change the world, first change yourself” means if we want to change the world
to survive for a long time, need to change our-self according upcoming society and
environment. So this organization will be best platform to improve myself and for
human safety also.

Why you left your previous organization?

First of all I would like to thanks to my previous organization to given me the
opportunity to work with them. I have learned lot of things how to work under pressure
with confidence and how to make relationship with co-workers professionally. Now I
am looking for new challenges and have to update my skill with new technology along
with company growth.

Why you came here?

As we know Bangalore is the city of great career opportunities for Pharma and Life
Science Candidates. Indian technological organisations ISRO, Infosys, Wipro,
Flipkart, Biocon and HAL are headquartered in the city. Bangalore is also known as
startup capital of India.

Leading CROs/Pharma or IT Companies like Quintiles, Biocon, Parexel,

Novonordisk, Accenture, TCS, Wipro, Cognizant, Ecron Acunova, Icon, Pfizer,
PPD Pharma etc are making it a preferred destination for Pharma-Life Science
Students. These companies are employing over thousands of professionals.

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 Abbreviations
ADR (Adverse Drug Reaction)
AE (Adverse Event)
ANADAs (Approved abbreviated new drug application)
AND (Abbreviated New Drug)
ASC (Ambulatory Surgical Center)
CAP (Centralised Authorisation Procedure)
CBER (Center for biologics evaluation and research)
CCDS (Company Core Data Sheet)
CCSI (Company Core Safety Information)
CDER (Center for Drug evaluation and research)
CDM (Clinical Data Managment)
CDRH (Center for device and radiological)
CDSCO (The Central Drugs Standard Control Organization)
CDISC (Clinical Data Interchange Standards Consortium)
CIOMS (Council for International Organization of Medical Sciences)
CRC (Clinical Research Co-ordinator)
CRF (Clinical Report form)
CSR (Clinical Study Report)
CSV (Computer system validation)
CTD (Clinical Trial Disclosure) / (Common Technical Document)
CTP (Center for tobacco product)
CVM (Center for veterinary medicine)
DCGI (Drugs Controller General of India)
DCP (Decentralized Procedure)
DDPS (Detailed Description of the Pharmacovigilance System)
DMF (Drug master file)
DLP (Data Lock Point)
DSRU (Drug Safety Research Unit)
DSUR (Dovelopment Safety Update Reports)
eMDR (Electronic medical device report)
EURD (European Enion Reference Date)
EOR (Explanation of Review)
EVMPD (Eudravigilance Medical Product Dictionary)
xEVMPD (Extended Eudravigilance Medical Product Dictionary)
FAERS (FDA adverse event system)
FDAAA (Food and drug administration amendment act)
FDAESG (FDA electronic submission gateway programme)
GVP (Good Pharmacovigilance Practice)
HBD (Harmonised Birth Date)
HIPAA (Human Insurance Portability and Accountability act of 1966)
HMA (Heads of Medicine Agency)
DIBD (Development International Birth Date)
ICD (The International Classification of Diseases)
ICH (International Conference on Harmonization of Technical requirement for
registration of Pharmaceuticals for Human use)
ICSR (Individual Case Safety Report)
IND (Investigational New Drug)

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INN (International Non-proprietary Name)
MAA (Marketing Authorization Application)
MAH (Marketing Authorization Holder)
MCC (Medicine control organisation)
MHRA (United Kingdom medicine and health care products regulatory agency)
MedDRA (Medical Dictionary for Regulatory Activities)
MRP (Mutual Recognition Procedure)
MSSA (Methicillin Sensitive Staphylococcus Aureus)
MSSO (Maintenance and Support Services Organization)
NADAs (New animal drug application)
NAP (National Authorized Products)
NCA (National Competent Authority)
NDA (New Drug Application)
NES (Not Elsewhere Classified)
NOS (Not Otherwise Specified)
NPP (The National Pharmacovigilance Program)
PADERs (Periodic Adverse Drug Experience Reports)
PASS (Post Authorisation safety study)
PAES (Post authorization efficacy study)
PBRER (Periodic Benefit Risk Evaluation report)
PEM (Prescription Event Monitoring)
PIL (Patient Information Leaflet)
POM (Prescription Only Medicine)
PPP (Pregnancy Prevention Programme)
PRAC (Pharmacovigilance risk assessment committee)
PSUR (Periodic Safety Update Reports)
PSUSA (PSUR single assement)
QPPV (Qualified Person for Pharmacovigilance )
RADAR (The Research on Adverse Drug Events and Reports)
RBM (Risk Based Management)
RECIST (Response evaluation criteria in solid tumors)
REMS (Risk Evaluation and Mitigation Plan)
RMP (Risk Management Plan)
SDV (Source Document Verification)
SMQ (Standard MedDRA Query)
SOC (System Organ Class)
SPC (Summary of Product Characteristics)
SUSAR (Suspected unexpected adverse drug reaction)
TGA (Thereuptics goods administration)
UAT (User accepatance testing)
VAERS (Vaccine adverse event reporting system)
VAESCO (Vaccine Adverse Event Surveillance and Communication)

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Clinical trial
A systematic study on pharmaceutical products in human subjects (including patients
and other volunteers) in order to discover or verify the effects of and/or identify any
adverse reaction to investigational products, and/or to study the absorption, distribution,
metabolism and excretion (ADME) of the products with the objective of ascertaining
their efficacy and Safety.

Figure- Different Phase of clinical trial

Note- Phase 0
Recently implemented, Drug with small dose subjected to human being (15 Patients)
and try to find out whether drug reaches tumour and how drug act in body and how
cancer cell respond to drug. In this study need extra biopsy, scan and blood sample.
 Greater difference between Phase 0 and Phase I. In “0” Phase, there is no any
chance to get benefit for volunteer due to small dose.
Major Regulatory authority
ICH
CIOMS
INDIA: CDSCO
United State: USFDA
United Kingdom: MHRA (Medicine and health care products regulatory agency)
Japan: MHLW (Ministry of Health Labour & Welfare) & PMDA (Pharmaceuticals
and Medical devices Agency)
European Union: EMEA (European Medicine Evaluating Agency)
Australia: TGA (Therapeutic goods Administration) & ARTG (Australian Register
of Therapeutic goods)

Pharmacovigilance
Pharmacovigilance is the pharmacological science relating to the detection, assessment,
understanding and prevention of adverse effects of post marketing drugs.
Adverse Drug Reaction (ADR)
A response which is noxious and unintended, and which occurs at doses normally used

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in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification
of physiological function. (WHO, 1972).
Side effect
Any unintended effect of a pharmaceutical product occurring at normal dosage which
is related to the pharmacological properties of the drug.

Adverse Event (AE)

Any untoward medical occurrence that may present during treatment with a
pharmaceutical Products but which does not necessarily have a causal relationship with
this treatment.
Causal relationship
A relationship between one phenomenon or event (A) and another (B) in which A
precedes and causes B. In pharmacovigilance; a medicine causing an adverse reaction.
Causality assessment
The evaluation of the likelihood that a medicine was the causative agent of an observed
adverse reaction. Causality assessment is usually made according established
algorithms.
Causality Assessment criteria
1. The association in time between drug administration and event.
2. Pharmacology (Features and previous knowledge of side effect)
3. Medical plausibility (Characteristic sign and symptoms, lab tests, pathological
finding)
4. Likelihood or exclusion of other cause

Causality assessment Methods

Naranjo’s algorithm, Jones algorithm, Kramer algorithm and Binary methods Begaud
algorithm, Karch and Lasagna algorithm, Thai algorithm etc.
De-challenge\ Re-challenge
Basically, it is used to check weather adverse event has causal relationship with drugs
or not.
De-challenge
The clinical decision to withdraw drug from a patient; resulting, reduction or
disappearance of adverse effects is called positive dechalenge and if adverse effect still
persist, is called negative dechalenge.
Re-challenge
Reintroducing of same drugs resulting patient gets experience with adverse effect
again is called Rechalenge.

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Why Pharmacovigilance in India?
The information collected during the pre-marketing phase of a medical drug is
inevitably incomplete with regard to possible adverse reactions:
1. Tests in animals are insufficiently predictive of human safety
2. Patients in clinical trials are selected and limited in number, the conditions of use
differ from those in clinical practice and the duration of trials is limited
3. Information about rare but serious adverse reactions, chronic toxicity, and use in
special groups (such as children, the elderly or pregnant women) or drug interactions
is often incomplete or not available.
What are the major aims of Pharmacovigilance?
Pharmacovigilance is concerned with the detection, assessment and prevention of
adverse reactions to drugs. Major aims of pharmacovigilance are:

 Early detection of hither to unknown adverse reactions and interactions

 Detection of increases in frequency of (known) adverse reactions
 To improve patient care and safety
 To improve public health and safety
 To contribute to the assessment of benefit, harm,
 Effectiveness and risk of medicines
 To promote education and clinical training
 To promote effective communication to the public
 To promote rational and safe use of medicines
Prescription Event Monitoring (PEM)
System created to monitor adverse drug events in a population. Prescribers are
requested to report all events, regardless of whether they are suspected adverse events,
for identified Patients receiving a specified drug. Also more accurately named Cohort
Event Monitoring.
Prescription Only Medicine (POM)
Medicinal product available to the public only on prescription

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Serious Adverse Event or Reaction
A serious adverse event or reaction is any untoward medical occurrence that at any
dose:
 results in death
 requires inpatient hospitalisation or prolongation of existing hospitalisation
 results in persistent or significant disability/incapacity is life-threatening

Suspected Unexpected Serious Adverse Reactions (SUSAR)

An adverse reaction that is both unexpected (not consistent with the applicable product
information) and also meets the definition of a Serious Adverse Event/Reaction.

Pharmacovigilance – Software/Data Base

 Argus (More Friendly and more advance)
 ARISg
 Eudravigilence
 Medwatch
 Oracle AERS (For FDA use)
 Clintrace
 PVNET
 repClinical
 Vigilanze dynamic monitoring system
 WebVBME

The name of the WHO Global ICSR Database.

 Vigi-Base
 Vigi-Flow
 Vigi-med
 Vigi-Mine
 Vigi-Search

Medical Dictionary
 WHO-ART
 MedDRA
 Common Drug Dictionary
 WHO Drug Dictionary (WHO DD)
.
Data mining
A general term for computerised extraction of potentially interesting patterns from large
data sets often based on statistical algorithms. In pharmacovigilance, the commonest
application of data mining is so called disproportionality analysis, for example using
the Information component (IC).
Disproportionality analysis
Screening of ICSR databases for reporting rates which are higher than expected. For
drug-ADR pairs, common measures of disproportionality are the Proportional
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Reporting Ratio (PRR), the Reporting Odds Ratio (ROR), The Information Component
(IC), and the Empirical Bayes Geometrical Mean (EBGM). There are also
disproportionality measures for drug-drug-ADR triplets, such as Omega (Ω).
Efficacy
The ability of a drug to produce the intended effect as determined by scientific methods,
for example in pre-clinical research conditions (opposite of hazard).

Epidemiology
The science concerned with the study of the factors determining and influencing the
frequency and distribution of disease, injury and other health-related events and their
causes in a defined human population for the purpose of establishing programs to
prevent and control their development and spread.

Essential medicines
Essential medicines are those that satisfy the priority health care needs of the
population. They are selected with due regard to public health relevance, evidence on
efficacy and safety, and comparative cost-effectiveness.

Frequency of ADRs
In giving an estimate of the frequency of ADRs the following standard categories are
recommended:
Very common* > 10%
Common (frequent) >1% and <10%
Uncommon (infrequent) >0.1% and < 1%
Rare >0.01% and <0.1%
Very rare* <0.01%
Information component (IC)
The Information component (IC) measures the disproportionality in the reporting of a
drug-ADR pair in an ICSR database, relative to the reporting expected based on the
overall reporting of the drug and the ADR. Positive IC values indicate higher reporting
than expected. The IC has also been implemented on electronic health records, to detect
interesting temporal relationships between drug prescriptions and medical events.

Individual Case Safety Report (ICSR)

A report that contains ‘information describing a suspected adverse drug reaction related
to the administration of one or more medicinal products to an individual patient.

MedDRA
MedDRA (Medical Dictionary for Regulatory Activities) is a clinically validated
international medical terminology in which adverse event are classified according to
System organ Class (SOC). MedDRA is organized by SOC which includes four level-
HLGT (High level group term)
HLT (High level term)
PT (Preferred term)
LLT (Lowest level term)
MedDRA update twice in year, March and September and current version is 19.1.
Note: MedDRA is controlled by ICH MedDRA Maintenance and Support Services
Organization (MSSO).

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Reporting Timeline-
 Fatal or life threating SUSAR-within 7 calender days
 Non-fatal/non-life threating SUSAR-within 15 calender days
 Death in SUSAR-within 24 Hours

OTC (Over the Counter) medicine

Medicinal product available to the public without prescription.
Periodic Safety Update Report (PSUR)
A systematic review of the global safety data which became available to the
manufacturer of a marketed drug during a specific time period. Produced in an
internationally agreed format.

This and other requirements for PSUR submission can be found in Schedule Y.

PSUR is pharmacovigilance document which provide comprehensive and analysis of

risk benefit balance or safety information of a particular drug at periodic basis.
Note- The Good vigilance practice (GVP) module VII provide guidance on the
preparation, submission and assessment of PSURs.

Development safety update report (DSUR)

The main focus of the DSUR is data and findings from interventional clinical trials*
The DSUR should provide safety information from all ongoing clinical trials and other
studies that the sponsor is conducting or has completed during the review period
including:

 Clinical trials using an investigational drug (i.e., human pharmacology,

therapeutic exploratory and therapeutic confirmatory trials [Phase I – III]);
 Clinical trials conducted using marketed drugs in approved indications (i.e.,
therapeutic use trials (Phase IV));
 Therapeutic use of an investigational drug

The DSUR should also include other significant information like

 Observational or epidemiological studies;

 Non-clinical studies (toxicological and in vitro studies);
 Manufacturing or microbiological changes;

Signal detection
The signal management process can be defined as the set of activities performed to
determine whether there are new risks associated with an active substance or a
medicinal product or whether known risks have changed.

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Pharmacoepidemiology
Study of the use and effects of drugs in large populations.
Overdose
This refers to the administration of a quantity of a medicinal product given per
administration or cumulatively, which is above the maximum recommended dose
according to the authorised product information. Clinical judgement should always be
applied.
Off-label use
This relates to situations where the medicinal product is intentionally used for a
medical purpose not in accordance with the authorised product information.
Misuse
This refers to situations where the medicinal product is intentionally and
inappropriately used not in accordance with the authorised product information.
Abuse
This corresponds to the persistent or sporadic, intentional excessive use of a medicinal
product, which is accompanied by harmful physical or psychological effects.
Pharmacology
Study of the uses, effects and modes of action of drugs.
Phocomelia
Characteristic deformity caused by exposure to thalidomide in the womb, also very
rarely occurring spontaneously. Meaning: limbs like a seal.

Placebo
An inactive substance (often called a sugar pill) given to a group being studied to
compare results with the effects of the active drug.

Prophylaxis: Prevention or protection.

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Summary of Product Characteristics (SPC)
Resume of a particular Medicinal product
A regulatory document attached to the marketing authorization which forms the basis
of the product information made available to prescribers and patients. It contains
information about drug from preclinical study to clinical trails study.

Case Report Form (CRF)

A printed, optical, or electronic document designed to record all of the protocol required
information to be reported to the sponsor on each trial subject.
Contract Research Organization (CRO)
A person or an organization (commercial, academic, or other) contracted by the sponsor
to perform one or more of a sponsor's trial-related duties and functions.
Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording,
analyses, and reporting of clinical trials that provides assurance that the data and
reported results are credible and accurate, and that the rights, integrity, and
confidentiality of trial subjects are protected.
Quality Assurance (QA)
All those planned and systematic actions that are established to ensure that the trial is
performed and the data are generated, documented (recorded), and reported in
compliance with Good Clinical Practice (GCP) and the applicable regulatory
requirement(s).

Quality Control (QC)

The operational techniques and activities undertaken within the quality assurance
system to verify that the requirements for quality of the trial-related activities have been
fulfilled.
Severity Vs Seriousness
The term "severe" is often used to describe the intensity (severity) of a specific event
(as in mild, moderate, or severe myocardial infarction); This is not the same as
"serious," which is based on patient/event outcome or action criteria usually associated
with events that pose a threat to a patient's life or functioning.
Criteria for serious adverse event or serious ADR
Untoward medical occurrence at any dose result include any of followings-
 Death
 Life threatening
 Require inpatient hospitalization
 Prolongation Hospitalization
 Significant disability of any organ
 Birth defect

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Valid case or Valid ICSR- must include following all 4 criteria
1-Reporter should be identifiable like, HCP (Health Care Professional))
2-Patient should be identifiable
3-Drug should be identifiable
4-Adverse effect should be identifiable
What do you know about E2a, E2b and E2c guidelines?
E2a: E2a guidelines give standard definitions and terminology for key aspects of
clinical safety reporting. It also gives guidance on mechanisms for handling expedited
(rapid) reporting of adverse drug reactions in the investigational phase of drug
development.
E2b: E2b guidelines for the maintenance of clinical safety data management and
information about the data elements for transmission of Individual Case Safety
Reports.
E2c: E2b guidelines for the maintenance of clinical safety data management and
information about the Periodic Safety Update Reports for marketed drugs.

What is Volume 9A?

Volume 9A brings together general guidance on the requirements, procedures, roles
and activities in the field of pharmacovigilance, for both Marketing Authorisation
Holders (MAH) and Competent Authorities of medicinal products for human use; it
incorporates international agreements reached within the framework of the
International Conference on Harmonisation (ICH).
Volume 9A is presented in four parts:
Part I deals with Guidelines for Marketing Authorisation Holders;
Part II deals with Guidelines for Competent Authorities and the Agency;
Part III provides the Guidelines for the electronic exchange of pharmacovigilance in
the EU
Part IV provides Guidelines on pharmacovigilance communication

Periodic Safety Update Reports

PSURs provide regulators in India with an update of the worldwide safety data of a
marketed drug, biological product or device at defined time intervals. PSURs are
considered to be an especially important pharmacovigilance tool: in India, they are
required to include the Safety data on a particular drug from all sources and
geographical regions.

Medical writing
It involves writing scientific documents of different types which include regulatory and
research related document disease or drug related educational and promotional
literature, publication article like health care website and health related magazine.
Clinical Data Management
Clinical Data Management (CDM) is a critical phase in clinical research, which leads
to generation of high quality, reliable, and statistically sound data from clinical trials.
This helps to produce a drastic reduction in time from drug development to marketing.
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Team members of CDM are actively involved in all stages of clinical trial right from
inception to completion.Various procedures in CDM including Case Report Form
(CRF) designing, CRF annotation, database designing, data entry, data validation,
discrepancy management, medical coding, data extraction, and database locking are
assessed for quality at regular intervals during a trial.
The primary objective of CDM processes is to provide high quality data by keeping
the number of errors and missing data as low as possible and gather maximum data for
analysis.

Tools for CDM

Many software tools are available for data management, and these are called Clinical
Data Management Systems (CDMS). In multicentric trials, a CDMS has become
essential to handle the huge amount of data. Most of the CDMS used in pharmaceutical
companies are commercial, but a few open source tools are available as well.
Commonly used CDM tools are ORACLE CLINICAL, CLINTRIAL, MACRO,
RAVE, and eClinical Suite. Among the open source tools, the most prominent ones are
OpenClinica, openCDMS, TrialDB, and PhOSCo.
Expedited Reporting
This refers to ICSRs that involve a serious and unlabelled event (an event not
described in the drug's labeling) that is considered related to the use of the drug.
Aggregate reporting
Aggregate reporting involves the compilation of safety data for a drug over a
prolonged period of time (months or years).
NOS (Not Otherwise Specified)
In MedDRA, “NOS” terms are only found on the LLT level and are meant to
represent concepts for which no further specific information is available (e.g., during
coding of adverse events).
NEC (Not Elsewhere Classified)
The “NEC” designation is used only with HLTs and HLGTs for grouping purposes.
For example, HLT Bladder disorders NEC includes a diverse range of PTs including
PT Bladder stenosis, PT Bladder granuloma and PT Bladder telangiectasia.
Reporting timeline for serious adverse event:
Non-Life threating with SUSAR -15 calendar days (USA)
Non-Life threating with SUSAR -14 calendar days (INDIA)
Life threating with SUSAR -7 calendar days
Death with SUSAR-24 hours
All serious in EU (European Union)/ Non EU- 15 calendar days
All non-serious in EU-90 calendar days
GD and Assay topics
 Joint family Vs Nuclear family
 Cricket is overrated game in India

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  Indian culture Vs western culture
 Global warming
 Hard work vs Smart work
 Green India
 Change in education system
 Importance of sports for in School
 Pros and cons about social networking site

 Animal cruelty should be continued

 Smart phone
ICH
The International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) is unique which brings together the regulatory
authorities and pharmaceutical industry to discuss scientific and technical aspects of
drug registration.
ICH has gradually evolved, to respond to the increasingly global face of drug
development. ICH's mission is to achieve greater harmonisation worldwide to ensure
that safe, effective, and high quality medicines are developed.
Regulatory harmonization offers many direct benefit to both regulatory authority and
pharmaceutical industries with beneficial impact for the protection of public health.
ICH harmonization is achieved by developing guidelines into four categories as
follows:
Q-Quality Guidelines: Defining relevant threshold for impurities testing and more
flexible approach to pharmaceutical quality based on GMP risk management.
S-Safety Guidelines: ICH has designed a comprehensive set of guidelines to uncover
potential risk like Carcinogenicity, Genatotoxicity, Reproductive toxicity.
E-Efficacy Guidelines: It concerned with design, conduct, safety and reporting
clinical trial.
M-Multidisciplinary Guideline: These guidelines do not have direct connection with
Safety, Efficacy and Quality categories. It includes medical terminology MedDRA,
CTD, and the development of Electronic Standards for the Transfer of Regulatory
Information (ESTRI).
Purpose of ICH
 Harmonization of technical requirements.
 Ensure safety, efficacy and quality of medicine.
 Prevent duplication of clinical trial in human.
 Minimize the use of animal testing without compromising safety and
effectiveness.

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Website: http://www.ich.org/products/guidelines.html

CIOMS (The Council for International Organizations of Medical Sciences)

CIOMS is an international nongovernmental organization established jointly
by WHO and UNESCO in 1949, and provide international ethical guidelines for
biomedical research involving human subjects.

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 Pharmacovigilance working Scenarios
1st- CPO unit & 2nd -Core processing unit
CPO (country Pharma Organization): Identify POP & batch case
validation forward to core unit
Core case processing: Book in and processing the case.
PV includes mainly two steps- 1st -Book in and 2nd -processing of cases
Types of PV case-> Batch case (mostly non serious & reported in excel sheet
containing more than one patient information). POP (Patient Oriented Program): one
POP Id for only one patient in specific CIOMS format.
Book in steps:
Check the case whether valid (4 criteria’s)? Book the valid case specific ID
created.
Processing: Booked case IDs allotted for processing open the ID in particular
data base specific blank fields (Tabs) opens related to Patient, Product, Event,
Analysis (narrative) and Additional (source document attachment) open the tabs
and enter the related information lock non-serious case & don’t lock serious
case rout the case for QC (quality check) to next level.
[QC person check serious case routed MR (medical reviewer) for seriousness
judgment and lock the case] after locking the case it is automatically submitted
to regulatory authority of particular country.
Explanation: Prior to book the case, we need to check weather case is valid or not. If
case would be found valid, we used to book the case for processing and then we
categorize on the basis of severity. Non-serious case should be locked and serious
case should be forwarded to medical reviewer.
Case processing is the way to process medical information which is taken in particular
format i.e ICSR.
Basics step:
1. Data collection or collection of report
2. Validation of report
3. Follow up
4. Data management
5. Quality management

1. Data collection or collection of report

a) Solicited report: A/c to ICH E2B, solicited report of suspected ADR
are those derived from organized data collection system which include
Clinicl trial, Non-interventional study, Disease management
programme, Post approval named patient programme, survey of
patient.
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 b) Unsolicited report:
I. Spontaneous report: It is unsolicited communication by Health
care professional (HCP) or consumer to a competent authority
(CA), Marketing authorization holder(MAH),
Pharmacovigilance center (PVc) or Poison control center.
II. Literature report: Scientific and Medical literature are a
significant source of information for monitoring safety profile
and risk benefit balance. Basically we are using reference
database eg. Medline, EMBASE and Excerpta media.
III. Report from other source: Non-medical source like -press or
media.
IV. Report from internet or digital media

2. Validation of report: Prior to book in case we have to validate the case by

evaluating following four criteria:
1-Reporter should be identifiable like, HCP (Health Care Professional
2-Patient should be identifiable
3-Suspected Drug should be identifiable
4-Suspected Adverse event should be identifiable

3. Follow-up: In case of incomplete information, we used to mark as follow-up

to obtained supplementary information to process the case.
4. Data management:
5. Quality management:

Black Box Warning

In the US, a black box warning/ black label warning means that medical studies
indicate that the drug carries a significant risk of serious or life-threatening adverse
effect. For example all antidepressant medication carries black box warning.

Suspect drug: Drug that was suspected by patient to caused reaction. It can be direct
suspicion or indirect suspicion.
Co-suspected drug: Drugs along with suspected drug caused an adverse event
Concomitant Drugs: Drugs taken along with suspect drug.
Past drugs: Drugs stopped before starting the suspected drug.
Suspected Adverse Reaction: Where drug has reasonable causal relationship with
the AE.

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