Part 3 of our journey into the world of pharmacovigilance, titled 'Global Perspectives in Pharmacovigilance,' offers a panoramic view of the international landscape shaping drug safety. This installment transcends geographical boundaries, unraveling the complexities of harmonizing pharmacovigilance efforts worldwide. As we delve into regulatory frameworks and challenges across diverse regions, the audience gains insights into the intricate tapestry of global drug safety initiatives. From examining collaborative efforts among regulatory bodies to exploring innovations that bridge cultural and regulatory differences, Part 3 underscores the importance of a unified approach to ensure the safety of pharmaceutical products on a global scale. With a focus on navigating regulatory challenges and fostering international cooperation, this segment equips participants with a holistic understanding of the diverse perspectives that contribute to the evolving field of pharmacovigilance.

1. Interview Preparation Questions
PHARMACOVIGILANCE
PART-3

2. INDEX
1
2
3
4
5
1.What is a Signal in Pharmacovigilance?
2.Define CRF.
3.Define SUSAR.
5.What is day ‘0’or Initial receipt date?
4.What is a Valid Case?

3. •A signal in pharmacovigilance is defined as “Reported
information on a possible causal relationship between an
adverse event and a drug, the relationship being previously
unknown or incompletely documented.(WHO2002)
•Usually more than a single report is required to generate a
signal,depending on the seriousness of the event and
qualityoftheinformation.
•GVP Module IX talks about signal management.
What is a Signal in Pharmacovigilance?

4. •A case report form (CRF) is a printed or electronic
document designed to record all protocol-
required information on each subject in a clinical
research study.
•The CRF facilitates complete and standardized
data collection that promotes efficient processing,
analysis, and reporting of information,as well as
exchange of data across sites and to the
Sponsor/Principal Investigator/Data Coordinating
Center.
Define CRF.

5. •SUSAR is Suspected Unexpected
Serious Adverse
Reactions associated with drugs
for human use.
Define SUSAR

6. •A case is considered valid if it has an,
•Identifiable reporter,
•Identifiable subject,
•A suspect drug,
•An adverse event or adverse drug reaction.
What is a Valid Case?

7. •The date of initial awareness or receipt date of a
valid ICSR by a company/company’s
representative irrespective of the holiday is day ‘0’.
•It is the start date of regulatory timeline for a case.
•It is the date when the Pharmacovigilance
department has received the valid ICSR
information.
Whatis day ‘0’or Initial receipt date?

9. Acheivements-
2023