Pregnancy Reports. All reports of drug exposure to a pregnancy (male or female partner using the Product) received by either Party, including both, those reports associated with an adverse event and those reports not associated with an adverse event, will be exchanged. Serious AEs will be treated as explained in Sections 2.1 and 2.2 of this Exhibit. If a non-serious AE or no adverse event is involved and the report is simply one of a pregnancy in a patient or partner on the Product the report is to be sent to DSS within seven (7) calendar days. The pregnancy will be followed to term by the reporting group and/or DSS to obtain the outcome of the pregnancy (Pregnancy Register).
Pregnancy Reports. Reports of pregnancy following maternal or paternal exposure to the product. Product Complaints: Complaints arising from potential deviations in the manufacture, packaging or distribution of the Medicinal Product. Product Labelling: Description of the Medicinal Product and summary of use, safety, and effectiveness that is used internally (e.g. IB and CCSI) or which must be approved by Regulatory Authorities (e.g., Summary of Product Characteristics in the EU). Qualified Person for Pharmacovigilance (“QPPV”): A person from within the EEA Territory appointed by the MAH as responsible for the establishment and maintenance of the Pharmacovigilance system as it pertains to the EEA. Regulatory Authority: Any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities, including the U.S. Food and Drug Administration, the European Medicines Agency, the European Commission, or any other entity exercising regulatory authority with respect to the development, registration, manufacturing, marketing, distribution, transportation, or sale of a Medicinal Product. Risk Management Plan: A document which describes a set of Pharmacovigilance activities and interventions designed to proactively identify, characterise and prevent or minimise risks related to Medicinal Products, including risk communication and the assessment of effectiveness of risk minimisation interventions. Safety Database: A validated database that stores data, compiles, integrates, and produces reports of AEs/SAEs from all reporting sources. Reporting capabilities include individual safety reports, Periodic Reports, and customised reports from queries.
Pregnancy Reports. All reports of drug exposure to a pregnancy (male or female partner using the product) received by either party, including both, those reports associated with an adverse event and those reports not associated with an adverse event, will be exchanged. Serious AE's will be treated as explained in sections 2.1 and 2.
Pregnancy Reports. Aspen will collect and report all reports of pregnancy from female patients or partners of male patients exposed to the Medicinal Products of which it becomes aware. Reports should be forwarded as per the timelines in Section 3.4.
