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 […]
ICH ICSR E2B R3 Guideline | How to Fill ICSR | What Data Needed in Individual case safety reports
ICH ICSR E2B R3 Guideline The ICH E2B EWG released an E2B guideline for Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSR) in 1997 and issued a revised […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]