Pharmacovigilance Interview Questions: What are the special situation cases?| Q21
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Загружено: 2021-09-21
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What are the special situation cases? Question - 21 Pharmacovigilance Interview Questions by Ramya. Watch all Interview Questions https://bit.ly/3iWqGRV . To know more details visit https://www.greatonlinetraining.com
Question - 21:What are the special situation cases?
Special Situations are non-standard medical conditions that provide valuable information (e.g. clinical, safety) about a medicinal product,
even when they don’t occur in association with an adverse event or medical condition. These are required to be reported to regulatory
authorities as per GVP and ICH guidelines and for benefit-risk assessment of medicines.
Few Examples of Special situations are:
Lack of efficacy
Medication error
Abuse/Misuse/Overdose
Off label use
Occupational exposure
Drug-Drug interaction
Drug exposure during pregnancy, Drug exposure via breast milk
Suspected Transmission of Infectious Agents
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