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 […]
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 […]
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 […]
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 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 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 […]
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 […]
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, […]
Targeted clinical investigations When significant risks are identified from pre-approval clinical trials, further clinical studies might be called in to evaluate the mechanism of action for the adverse reaction. In some instances, pharmacodynamics and pharmacokinetic studies might be conducted to […]
CROSS SECTIONAL STUDIES These are primarily used to determine prevalence. Prevalence equals the number of cases in a population at a given point in time. All the measurements on each person are made at one point in time. Prevalence is […]