Drug Safety Regulations In The Us And Eu

Pharmacovigilance in the US & EU Angie Barfield, RN, BSN 20 January 2009

When the system fails…. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Overview of Pharmacovigilance Literature Reports Spontaneous Reports Clinical Trial Data Regulatory Reports Licensing Partners Data Review Submission Amend Prescribing Information Review marketing status Licensing Partners World-wide Regulatory Reports (expedited and periodic) Enquiry Response Signal Generation Collect… Collate… Analyze… Communicate…

Risk Management Across the Lifecycle Product Life Cycle Capabilities Provided Approval Ph IV FIM PhI Ph II Ph III ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Post Marketing Pharmacovigilance Clinical Development Drug Discovery/ Preclinical

Regulatory Oversight ,[object Object],[object Object],[object Object],[object Object],US-FDA EU

Key Regulations Governing Pharmacovigilance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

MAA Approval Procedures in the EU ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Different Labeling Requirements & Different Expedited Reporting Requirements/Timelines

Pre-Marketing Safety Reporting (EU) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Investigator Reports all SAEs Sponsor Reports all SUSARs* CA EC EVCTM *S uspected U nexpected S erious A dverse R eaction

Pre-Marketing Safety Reporting (US) ,[object Object],[object Object],[object Object],[object Object],Investigator Reports all SAEs Sponsor Reports all ESRs* FDA IRB

Pre-marketing Periodic Reports Benefit-Risk Assessment Progress Report (focus on clinical development program) Purpose ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Format SUSARs; serious, associated, +/- expected Listings of all SAEs, deaths, ESRs, and withdrawals due to AEs for the reporting period Adverse Events Included Benefit-risk assessment; supporting tables Study data and summary information Content EMEA, MS, EC FDA Recipients Annual Safety Report (EU) IND Annual Report (US)

Pediatric Legislation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],EU US

Post-Marketing Safety Reporting ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

PADER vs. PSUR ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],PADER PSUR

Risk Management Plans ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Pharmacovigilance Audits ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Drug Safety Regulations In The Us And Eu

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