Category: Pharmacovigilance

Differences in Indian & Global Pharmacovigilance Requirement | Comparison of USA, India, European Pharmacovigilance System

Pharmacovigilance in India Indian pharmaceutical industries are estimated to account for about 3.5% in value of the international pharmaceutical industry. By 2020, it is expected to grow to US$55 billion and US$100 billion by 2025, thus evolving as the sixth […]

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CIOMS | CIOMS Working Group | History of CIOMS | Pharmacovigilance notes unit 5 | BPharm 8 semester

CIOMS: The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. CIOMS represents a substantial proportion of the biomedical scientific community through its member organizations, which include […]

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Expedited reporting | ICH Guidelines for Pharmacovigilance | MCQ | Pharmacovigilance Notes & Lecture for BPharm 8th Semester

STANDARDS FOR EXPEDITED REPORTING A. What Should be Reported? 1. Single Cases of Serious, Unexpected ADRs All adverse drug reactions (ADRs) that are both serious and unexpected are subject to expedited reporting. This applies to reports from spontaneous sources and […]

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ICH Guidelines for Pharmacovigilance | Organization and objectives of ICH | Pharmacovigilance Notes for BPharma 8 semester

Introduction: • ICH is the “International Conference on Harmonization” of technical requirements for the registration of pharmaceuticals for human use. • To assure safety, quality and efficacy of medicines, the members of ICH who include members from drug regulatory authorities […]

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Pre Clinical Phase | Safety data generation | Pharmacovigilance Unit 4 Notes and Lecture

Preclinical studies are performed in in vitro, in vivo, ex vivo, and in silico models to obtain basic information about the safety and biological efficacy of a drug candidate before testing it in a final target population, i.e., humans. Preclinical […]

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Clinical Trials Phases | Differences in various phases of Clinical Trials | Pharmacovigilance Notes & Lecture

Clinical trial phases are steps in the research to determine if an intervention would be beneficial or detrimental to humans and include Phases 0, I, II, III, IV,  clinical studies . During Phase 0, pharmacodynamics and pharmacokinetics are determined. Safety […]

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Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media | Pharmacovigilance Notes Unit 3

Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media Communication with Media: Who are the media?  Print -magazines, newspapers, community newspapers  Electronic -radio, TV, internet  Local and national levels Some basic questions a reporter will ask […]

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Communication in Drug Safety Crisis management | Communication in Pharmacovigilance | Pharmacovigilance Unit 3 Notes

Definition of Crisis: Any event that comes to public notice and threatens the health or safety of individuals or groups, or the reputation or stability of an organization. Crises usually erupt suddenly and dramatically; they require rapid and effective response […]

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Effective communication in Pharmacovigilance | Pharmacovigilance Notes of Unit 3

Communication: The act of sharing or exchanging information, ideas or feelings. Principles of Good Pharmacovigilance Communication  Relate the messages to the audience’s perspective  Avoid comparisons which trivialize the concern  Ensure completeness of the message  Be balanced, […]

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