"Pharmacovigilance Interview Question Part 1." In this insightful presentation, we delve into the crucial world of pharmacovigilance, exploring fundamental concepts and key questions that play a pivotal role in ensuring drug safety and healthcare integrity.
2. INDEX
1
2
3
4
5
Define and explain Pharmacovigilance.
What is the significance of Pharmacovigilance in
maintaining public/patient safety ?
What are Regulatory or Health authorities (RA/HA)
and name some of the countries' RAs?
5. How is ICH Categorized?
Elaborate ICH and its participating countries.
3. Pharmacovigilance is the science and activities relating to the
detection, assessment, understanding and prevention of
adverse effects or any other drug- related problem (WHO
2002).
• Detection – of adverse event is done by investigator in case
of clinical trial, or by the health care professional i.e.,
physician treating the patient or by the patient himself.
• Assessment- the investigator or health care professional
would assess if the adverse event is drug related.
• Understanding-the safety specialist will be involved in
understanding the adverse event or drug related problem.
• Prevention-the regulatory bodies or MAH will take
precautionary actions to prevent future adverse events
related to the drug.
Define and explain Pharmacovigilance.
4. •Pharmacovigilance helps monitor the quality,
safety, and efficacy of the drugs.
•It also helps identify the unidentified or
unexpected AEs in the post marketed drugs.
•Helps in assessment of risk and benefits in the
marketed drugs.
•Helps in doing Risk analysis and mitigation.
What is the significance of
Pharmacovigilance in maintaining
public/patient safety ?
5. Regulatory Authorities are governmental or quasi-
governmental bodies established to carry out regulatory
activities relating to medicines, including the processing of
marketing authorizations, the monitoring of side effects,
inspections, quality testing and monitoring the use of
medicines.
Some of the Regulatory Authorities are,
•USA-FDA (Food and Drug Administration)
•Europe-EMEA (European Medicines Agency)
•UK-MHRA (The Medicines and Healthcare products Regulatory
Agency)
•Japan-MHL (The Ministry of Health, Labor and Welfare)
•India-CDSCO (Central Drug Standard Control Organization)
Whatare Regulatory orHealth Authorities
(RA/HA)and NameSome of the Countries’
RegulatoryAuthorities?
6. •ICH is the International Conference on Harmonization of
technical
requirements for registration of pharmaceuticals for
human use.
•It is a unique project that brings together the regulatory
authorities of Japan, Europe and USA and experts from
pharmaceutical industry to discuss scientific and
technical aspects of product registration.
•The participating countries are Japan, Europe and USA.
Elaborate ICH and its Participating
Countries
7. •The ICH topics are divided into 4 categories and ICH Codes are
assigned accordingly.
Quality- talks about Good Manufacturing Process (GMP) i.e.,
conduct of stability studies and defines the thresholds for
testing impurities.
Safety- talks about guidelines to uncover the potential risks of
carcinogenicity, genotoxicity and nephrotoxicity.
Efficacy- Focuses on the Design, Conduct, Reporting and
recording
of the clinical trials.
Multi-disciplinary- It includes the ICH medical terminology
(MedDRA), the Common Technical Document (CTD) and ESTRI
(Electronic Standards for the transfer of Regulatory
Information).
How is ICH Categorized?
