Inspection Findings and Responses. Principal Investigator and Institution will promptly forward to CRO and Pfizer copies of any inspection findings that either receives from a regulatory authority in relation to the Study. Whenever feasible and permitted by law, Principal Investigator and Institution will also provide CRO and Pfizer with an opportunity to prospectively review and comment on any responses to regulatory authority inspections in regard to the Study. e.
Inspection Findings and Responses. AMC will promptly forward to Pfizer copies of any inspection findings (e.g. Establishment Inspection Report, FDA Form 483 or USDA Inspection Report) that it receives from any regulatory agency in relation to the Program. Whenever feasible, AMC will also provide Pfizer with an opportunity to prospectively review and comment on AMC’s responses to regulatory agency inspections in regard to the Program.
Inspection Findings and Responses. Within five (5) Business Days of receipt, ArcherDX will forward to MRK copies of any inspection findings in any way related to the Activities that ArcherDX receives from a Regulatory Authority during the Term.
Inspection Findings and Responses. AMC will promptly forward to Company copies of any inspection findings (e.g. Establishment Inspection Report, FDA Form 483 or USDA Inspection Report) that it receives from any regulatory agency in relation to the Program. Whenever feasible, AMC will also provide Company with an opportunity to prospectively review and comment on AMC’s responses to regulatory agency inspections in regard to the Program.
Inspection Findings and Responses. Institution will promptly forward to CRO and Pfizer, or confirm that Principal Investigator has done so, copies of any inspection findings that Institution receives from a regulatory authority in
Inspection Findings and Responses. The Health Services Provider will promptly forward to CRO and Pfizer, or confirm that Principal Investigator has done so, copies of any inspection findings that the Health Services Provider receives from a regulatory authority in relation to the Study. The Health Services Provider will also cooperate with Pfizer as needed to help ensure that Principal Investigator forwards any inspection findings that Principal Investigator alone receives in relation to the Study. Whenever feasible and permitted by law, the Health Services Provider will provide CRO and Pfizer with an opportunity to prospectively review and comment on any Health Services Provider responses to regulatory authority inspections in regard to the Study. e. Nálezy inspekce a odpovědi. Poskytovatel zdravotních služeb bezodkladně předá CRO a společnosti Pfizer kopie veškerých nálezů inspekce, které obdrží od kontrolního úřadu v souvislosti se Studií, nebo potvrdí, že tak učinil Hlavní zkoušející. Poskytovatel zdravotních služeb bude rovněž v případě potřeby spolupracovat se společností Pfizer, aby bylo zajištěno, že Hlavní zkoušející předá všechny nálezy inspekce, které sám obdrží v souvislosti se studií. Kdykoli je to proveditelné a povolené ze zákona, poskytne Poskytovatel zdravotních služeb CRO a společnosti Pfizer příležitost k případnému posouzení a připomínkám návrh odpovědí Poskytovatele zdravotních služeb na výsledky Inspekce kontrolního úřadu týkající se Studie.
Inspection Findings and Responses. Institution will promptly forward to CRO and Pfizer, or confirm that Principal Investigator has done so, copies of any inspection findings that Institution receives from a regulatory authority in relation to the Study. Institution will also cooperate with Pfizer as needed to help ensure that Principal Investigator forwards any inspection findings that Principal Investigator alone receives in relation to the Study. Whenever feasible and permitted by law, Institution will provide CRO and Pfizer with an opportunity to prospectively review and comment on any Institution responses to regulatory authority inspections in regard to the Study. e. Nálezy inspekce a odpovědi. Zdravotnické zařízení bezodkladně předá CRO a společnosti Pfizer kopie veškerých nálezů inspekce, které v souvislosti s klinickým hodnocením zdravotnické zařízení obdrží od kontrolního úřadu, nebo potvrdí, že tak učinil hlavní zkoušející. Zdravotnické zařízení bude rovněž v případě potřeby spolupracovat se společností Pfizer, aby bylo zajištěno, že hlavní zkoušející předá všechny nálezy inspekce, které sám obdrží v souvislosti s klinickým hodnocením. Kdykoli je to proveditelné a zákonné, poskytne zdravotnické zařízení CRO a společnosti Pfizer příležitost k případnému posouzení a okomentování jakýchkoli odpovědí zdravotnického zařízení na inspekce kontrolního úřadu týkající se klinického hodnocení.
Inspection Findings and Responses. The Health Services Provider will promptly forward to CRO and Pfizer, or confirm that Principal Investigator has done so, copies of any inspection findings that the Health Services Provider receives from a regulatory authority in relation to the Study. The Health Services Provider will also cooperate with Pfizer as needed to help ensure that Principal Investigator forwards any inspection findings that Principal Investigator alone receives in relation to the Study. Whenever feasible and permitted by law, the Health Services Provider will provide CRO and Pfizer with an opportunity to prospectively review and comment on any Health Services Provider responses to regulatory authority inspections in regard to the Study.
Inspection Findings and Responses. Unless Contractor has confirmed that Principal Investigator or Institution has already done so, Contractor will promptly forward to Pfizer copies of any inspection findings that Contractor receives from a regulatory authority in relation to the Study. Whenever feasible and permitted by law, Contractor will also provide Pfizer with an opportunity to prospectively review and comment on any Contractor responses to regulatory authority inspections in regard to the Study.
Inspection Findings and Responses. Institution will promptly forward to Pfizer copies of any inspection findings (e.g., Establishment Inspection Report or FDA Form 483) that Institution receives from a regulatory agency in relation to a Study. Whenever feasible, Institution will also provide Pfizer with an opportunity to prospectively review and comment on any Institution responses to regulatory agency inspections in regard to a Study.
