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BayBiotech.NET Scope: the policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research. This policy does not affect any state, local or foreign laws or regulations which may otherwise be applicable and which provide additional protections for human subjects. Exclusions:  Research conducted in educational settings, examples: research on education instructional strategies, on comparison among instructional techniques, curricula, or classroom management methods.  Research involving survey procedures, interview procedures or observation of public behavior, unless information is recorded in such a manner that human subjects can be identified.  Research involving the collection of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or

BayBiotech.NET Pharmacovigilance is a branch that involves the identification and evaluation of safety signals generated by the usage of a medical product. Safety Signal: is a concern raised when excess of adverse events are observed compared to what would be expected with a product's use. Signals can arise from collection of post marketing data, preclinical data and events associated with other products in the same pharmacologic class. Even a single well-documented case report can be viewed as a signal, particularly if the report describes an event that is extremely rare in the absence of drug use. Signals indicate the need for further investigation, which may or may not lead to the conclusion that the product caused the event. After a signal is identified, it should be further assessed to determine whether it represents a potential safety risk and whether other action should be taken. Good Pharmacovigilance Practice is based on acquiring complete data from spontane