definiens: means any of the following events relating to the Product : Adverse Events, reports of overdose, medication error, off - label use, misuse, abuse, occupational exposure, suspectedtransmission of an infectious agent via a medicinal product, lack of efficacy, medication error, dispensing error, accidental exposure, maladministration, exposure during pregnancy andbreastfeeding, unexpected therapeutic effect, Adverse Events related to a quality defect of falsifiedproduct . Such kind of Safety Information may occur in context of a clinical trial or a post - authorizationstudy, or may be reported spontaneously by health care professionals, a Regulatory Authority, consumers, care givers, or identified from patient support and market research programs, social mediaactivities, studies / registries, literature screening, website monitoring or through any of the Purchaser’sdesignated Third Parties ( such as a distributor, for example )