The document provides a comprehensive overview of pharmacovigilance, including its definition, significance in public safety, and the role of regulatory authorities across various countries. It discusses the International Council for Harmonisation (ICH) and its guidelines related to pharmacovigilance, which cover safety reporting, risk management, and good clinical practices (GCP). Additionally, it outlines the Good Pharmacovigilance Practices (GVP) modules and their relevance in maintaining drug safety throughout various phases of drug use.

1. ClinoSol Research Pvt Ltd
Education and Research Center
PART
1
Presented by
B. Rajeshwari Pharm-D
Zeba NazneenM.Pharm
Pooja PatilB.Pharm
UzmaPharm-D

2. 01
DEFINE PHARMACOVIGILANCE AND EXPLAIN YOUR UNDERSTANDING OF PV IN YOUR OWN
WORDS
02
WHAT IS THE SIGNIFICANCE OF PHARMACOVIGILANCE IN MAINTAINING PUBLIC/PATIENT SAFETY AND
HOW IT IS ACHIEVED
03
WHAT ARE THE REGULATORY OF HEALTH AUTHORITIES (RA/HA) AND NAME SOME OF THE
COUNTRIES RA'S
04 ELABORATE ICH AND ITS PARTICIPATING COUNTRIES
05 HOW MANY TYPES OF ICH GUIDELINES ARE THERE AND EXPLAIN THEIR OBJECTIVES IN BRIEF.
06 IN WHICH ICH GUIDELINE INFORMATION ABOUT PHARMACOVIGILANCE WAS PROVIDED
07 WHAT IS E2 AND NAME THE DIFFERENT TYPES OF ITS GUIDELINES UNDER THIS SECTION?
08 DEFINE GVP AND HOW MANY MODULES ARE THERE IN IT?
09 WHAT ARE THE GVP MODULES THAT SPEAK ABOUT PHARMACOVIGILANCE
10 DEFINE GCP & NAME THE ICH GUIDELINE THAT DESCRIBES GCP & EXPLAIN IT'S PURPOSE
IN
D
E
X

3. Q U E S T I O N N O . 0 1
DEFINE PHARMACOVIGILANCE AND EXPLAIN YOUR UNDERSTANDING OF PV IN YOUR OWN
WORDS
A N S W E R
.
According to World Health Organization, Pharmacovigilance is defined as The Science
and activities Relating to the Detection, Understanding, Assessment and Prevention of
Adverse Effects or any Other Drug Related Problems.

4. Q U E S T I O N N O . 0 2
WHAT IS THE SIGNIFICANCE OF PHARMACOVIGILANCE IN MAINTAINING PUBLIC/PATIENT
SAFETY AND HOW IT IS ACHIEVED
A N S W E R
The role of pharmacovigilance is to identify new information of hazards associated
with medicines preventing harm to patients. It also explains the identification and
quantification of previously unrecognized adverse drug reactions and also to monitor
the safety of the product throughout the duration of its use.

5. Q U E S T I O N N O . 0 3
WHAT ARE THE REGULATORY OF HEALTH AUTHORITIES (RA/HA) AND NAME SOME OF THE
COUNTRIES REGULATORY AUTHORITIES
A N S W E R
Bodies having power to Regulate. In the ICH GCP Guidelines the expression of
Regulatory Authorities includes the Authorities that review submitted Clinical data
and those that conduct Inspections, these bodies are sometimes referred to as
Competent Authorities.
COUNTRY NAME OF REGULATRY AUTHORITY
India Central drug standard control organization
(CDSCO)
USA Food and Drug administration (FDA)
UK Medicines and healthcare products
regulatory agency (MHRA)
Australia Therapeutic goods administration (TGA)
Canada Health Canada
Europe European medicines agency

6. Q U E S T I O N N O . 0 4
ELABORATE ICH AND ITS PARTICIPATING COUNTRIES
A N S W E R
The International Council for Harmonization of Technical Requirements for
Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory
authorities and pharmaceutical industry to discuss scientific and technical aspects of
pharmaceuticals and develop ICH guidelines.
• The difference in the technical requirements and the procedures followed by different
countries made the global marketing of drugs as time consuming and expensive
• To reduce the cost and time required for the global marketing of drugs
Participating countries:-
ICH is comprised of representatives from six parties that represent the regulatory
bodies and research-based industry in the European Union, Japan and the USA

7. Q U E S T I O N N O . 0 5
HOW MANY TYPES OF ICH GUIDELINES ARE THERE AND EXPLAIN THEIR OBJECTIVES IN BRIEF.
A N S W E R
The ICH topics are divided into the four categories
Q-Quality Guidelines:
Harmonization achievements in the Quality area include pivotal milestones such as the conduct of
stability studies, defining relevant thresholds for impurities testing and a more flexible approach
to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.
Q1A-Q1F Stability Q2 Analytical Validation Q3A – Q3E Impurities Q4A- Q4B
Pharmacopoeias
Q5A- Q5E Quality of Biotechnological Products Q6A- Q6B Specifications Q7 Good
Manufacturing practices
Q8 Pharmaceutical Development Q9 Quality Risk Management Q10 Pharmaceutical Quality
System
Q11 Development and Manufacture of Drug Substances Q12 Life cycle Management
Q13 Continuous Manufacturing of drug substances and Drug product Q14 Analytical Procedure

8. A N S W E R
S- Safety Guidelines:
ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like
carcinogenicity, genotoxicity and nephrotoxicity. A recent breakthrough has been a non-clinical
testing strategy for assessing the QT interval prolongation liability: the single most important
cause of drug withdrawals in recent years.
1A- S1C Carcinogenicity Studies S2- Genotoxicity studies S3A- S3B Toxic kinetics and
Pharmacokinetics
S4 Toxicity Testing S5 Reproductive Toxicology S6 Biotechnological Product S7A-S7B
Pharmacology studies
S8 Immunotoxicology Studies S9 Non clinical Pediatric Safety
S12 Non clinical Bio distribution considerations for gene therapy products
E- Efficacy Guidelines:
The work carried out by ICH under the Efficacy heading is concerned with the design, conduct,
safety and reporting of clinical trials. It also covers novel types of medicines derived from
biotechnological processes and the use of pharmacogenetics/ pharmacogenomics techniques to
produce better targeted medicines.
E1 Clinical Safety for Drugs Used in Long Term treatment E2A E2F Pharmacovigilance
E3 Clinical Study Reports E4 Dose Response Studies E5 Ethnic Factors E6 Good Clinical
Practices
E7 Clinical Trials in Geriatric Populations E8 General Consideration for Clinical Trials
E9 Statistical Principles for Clinical trials E10 Choices of Control Group in Clinical Trials
E11 – E11A Clinical Trials in pediatric population E12 Clinical Evaluation by therapeutic
category
E14 Clinical Evaluation of QT E15 Definitions in pharmacogenetics
E16 Qualification of Genomic Biomarkers E17 Multi Regional Clinical Trials E18 Genomic
Sampling

9. A N S W E R
M-Multidisciplinary Guidelines:
Those are the cross-cutting topics which do not fit uniquely into one of the Quality,
Safety and Efficacy categories. It includes the ICH medical terminology (Med DRA),
the Common Technical Document (CTD) and the development of Electronic Standards
for the Transfer of Regulatory Information (ESTRI).
M1 Med DRA Terminology M2 Electronic Standards M3 Nonclinical Safety Studies
M4 Common Technical Document M5 Data Elements and Standards for Drugs
Dictionaries
M6 Gene therapy M7 Mutagenic impurities
M8 electronic common technical document M9 biopharmaceutics classification
system based bio waivers
M10 bioanalytical method validation M11 clinical electronic structured harmonized
protocol
M12 drug interaction studies M13 bioequivalence for immediate release solids oral
dosages forms

10. Q U E S T I O N N O . 0 6
IN WHICH ICH GUIDELINE INFORMATION ABOUT PHARMACOVIGILANCE WAS PROVIDED.
A N S W E R
In ICH guideline information about pharmacovigilance was provided in E2E
guidelines
E2E guidelines including pharmacovigilance planning
This guideline is intended to aid in planning pharmacovigilance activities, especially in
preparation for the early post marketing period of a new drug (in this guideline, the
term “drug” denotes chemical entities, biotechnology-derived products, and vaccines).
The main focus of this guideline is on a Safety Specification and Pharmacovigilance
Plan that might be submitted at the time of license application.
The guideline can be used by sponsors to develop a stand-alone document for regions
that prefer this approach or to provide guidance on incorporation of elements of the
Safety Specification and Pharmacovigilance Plan into the Common Technical
Document (CTD).

11. Q U E S T I O N N O . 0 7
WHAT IS E2 AND NAME THE DIFFERENT TYPES OF ITS GUIDELINES UNDER THIS SECTION?
A N S W E R
E2 Is For Pharmacovigilance(Safety Reporting On Clinical Trials)
Different Types Of Its Guidelines Under This Sections Are
E2A: EXPEDITED SAFETY REPORTING ON CLINICAL TRIALS
E2B: ELECTRONIC REPORTING OF INDIVIDUAL CASE SAFETY REPORT
E2C: PERIODIC BENEFIT-RISK EVALUATION REPORT
E2D: POST MARKETING EXPEDITED SAFETY REPORTING SYSTEM
E2E: PHARMACOVIGILANCE PLANNIG
E2F: DEVELOPMENT OF SAFETY UPDATE REPORT

12. Q U E S T I O N N O . 0 8
DEFINE GVPAND HOW MANY MODULES ARE THERE IN IT?
A N S W E R
Good Pharmacovigilance Practices (GVP) Are A Set Of Measures Drawn Up To
Facilitate The Performance Of Pharmacovigilance In The European Union(EU).GVP
Apply To Marketing Authorization Holders(MAH),The European Medicines
Agency(EMA),And Medicine Regulatory Authorized In EU Member States.
They Cover Medicine Authorized Centrally Via The Agency As Well As Medicines
Authorized At The National Level.
There Are Total XVI Modules In GVP Mentioned In Next Page

13. A N S W E R
MODULE-I: Pharmacovigilance system and their quality systems
MODULE-II: Pharmacovigilance system master file
MODULE-III: Pharmacovigilance inspection
MODULE-IV: Pharmacovigilance audits
MODULE-V: Risk management system
MODULE-VI: Management and reporting of adverse reaction to medicinal products
MODULE-VII: Periodic safety updates report
MODULE-VIII: Post-authorization safety studies
MODULE-IX: Signal management
.MODULE-IX(A):
.MODULE-IX(B):
MODULE-X: Additional monitoring
MODULE-XI: Public participation in pharmacovigilance
MODULE-XII: Continuous pharmacovigilance, Ongoing Benefit-Risk Evaluation,
Regulatory action and planning of public communication.
MODULE-XIII: Incident management
MODULE-XIV: Referral procedures for safety reasons
MODULE-XV: Safety communication
MODULE-XVI: Risk minimization measures: selection of tools and effectiveness
indicators

14. Q U E S T I O N N O . 0 9
WHAT ARE THE GVP MODULES THAT SPEAK ABOUT PHARMACOVIGILANCE
A N S W E R
GVP MODULES THAT SPEAK ABOUT PHARMACOVIGILANCE
MODULE-I
MODULE-II
MODULE-III
MODULE-IV
MODULE-VII
MODULE-XI
MODULE-XII

15. Q U E S T I O N N O . 1 0
DEFINE GCP & NAME THE ICH GUIDELINE THAT DESCRIBES GCP & EXPLAIN IT'S PURPOSE
A N S W E R
A) GCP is an international ethical that describes all stakeholders roles & expectations
an actions in clinical trial .
B) GCP includes aspects of clinical monitoring, reporting and archiving trials .
C) Addenda for important document and brochures for investigate .
This ICH GCP Guideline Integrated Addendum provides a unified standard for the
European Union, Japan, the United States, Canada, and Switzerland to facilitate the
mutual acceptance of data from clinical trials by the regulatory authorities in these
jurisdictions. In the event of any conflict between the E6(R1) text and the E6(R2)
addendum text, the E6(R2) addendum text should take priority.
The objective of this ICH GCP guidelines is to grant a unified degree for the European
union, Japan and the United mess to facilitate the mutual acceptance of clinical facts
by the dictatorial establishment in these province.