The New European PV Legislation: Issues and Challenges
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Transcript of The New European PV Legislation: Issues and Challenges
Regulatory Affairs Professional Society 2013 Annual Meeting September 30, 2013
John A. Clark, MD, MSPH President and Chief Medical Officer
PCSglobal
The New European PV Legislation: Issues and Challenges
PRIMARY PHARMACOVIGILANCE SYSTEMS
l Expedited adverse event case reports l Signaling and surveillance l Benefit-risk evaluations l Risk management
Medical Product Safety Safety-Related Information Systems
What are the major issues?
Safety-Related Information Systems Issues and Challenges Posed by EU Regulations
What are the biggest challenges?
SYSTEM ATTRIBUTES
l Purpose: identify ADRs with emphasis on unexpected, serious
l Product specificity: non-specific l Information unit: single patient adverse
experience(s) l Basic approach: medical interpretation of
cases l Typical analyses: individual case causality
analysis, review of line listings l Focus: risk
Safety-Related Information Systems Expedited Adverse Event Case Reports
ISSUES
l Enlargement of ADR definitions – Global safety experiences – All conditions of use – All reporting environments – All reporters
l Integration of medical services’ and manufacturer’s data systems – Messaging structures – Product and event dictionaries
Safety-Related Information Systems Expedited Adverse Event Case Reports
CHALLENGES
l Increased operational complexity – Comprehensive ADR capture – Increased scope of ADR – Processing timelines
l Integration of medical services data structures into case report systems – Electronic reports (ICH-E2B versus HL7 ICSR) – Event dictionaries (e.g., MedDRA, SNOMED versus ICD-10, LOINC)
Safety-Related Information Systems Expedited Adverse Event Case Reports
SYSTEM ATTRIBUTES
l Purpose: find safety issues that are unknown or incompletely understood
l Product specificity: both specific and non-specific l Information unit: exposed case series l Basic approach: exposed/control group
comparisons l Typical analyses: increased frequency
assessment, surveillance observed to expected, case-control study, cohort study
l Focus: risk, strength of association, risk factors
Safety-Related Information Systems Signaling and Surveillance
ISSUES
l Signals from non-interventional studies – Defining and retrieving NI studies – Large number of NI studies now published
every year l Rapid signal work-ups l Signal tracking l Signal escalation
Safety-Related Information Systems Signaling and Surveillance
CHALLENGES
l Finding, assessing, and triaging NI study evidence – Retrieval definitions – Impact of results, data quality – Selection of studies as safety signals – Archiving of NI study results
l Signal evaluation software l Inter-departmental linkage of signals l Signal escalation in outsourced environments
Safety-Related Information Systems Signaling and Surveillance
SYSTEM ATTRIBUTES
l Purpose: evaluate known benefits and risks of a healthcare product versus a standard
l Product specificity: mostly product specific l Information unit: endpoint comparisons
(efficacy, effectiveness, and risk) l Basic approach: weighted comparison of
aggregate benefits versus aggregate risks l Typical analyses: Variants of multiple
criteria decision analysis (MCDA) l Focus: benefit:risk balance
Safety-Related Information Systems Benefit-Risk Evaluations
ISSUES
l Integration of BRE processes into existing operations
l Design of BRE “calculator” – Formal MCDA modeling versus rule-based – Defining axes and units (scalar, categorical)
l Determining risk management responses l Trend toward products with complex
manufacturing requirements
Safety-Related Information Systems Benefit-Risk Evaluations
CHALLENGES
l Personnel/teams with wide range of analytical skills
l Process redesign l New kinds of modeling and technology l Information acquisition, transfer, and
visualization
Safety-Related Information Systems Benefit-Risk Evaluations
SYSTEM ATTRIBUTES
l Purposes: maximize benefits, minimize risks l Product specificity: entirely product specific l Information unit: time dependent
measurements of key processes/outcomes l Basic approach: key variable trend analyses l Typical analyses: rate trending, surveys,
audits l Focus: optimization of benefit:risk in target
and non-target populations
Safety-Related Information Systems Risk Management
ISSUES
l Assuring data integrity l Measuring program effectiveness
– Target population specificity (includes off label use)
– Ongoing, rather than intermittent l Focus on medication errors and
product monitoring l Increasingly complex tool kit l Implementation in multiple territories
Safety-Related Information Systems Risk Management
CHALLENGES
l Teams with broad range of skills l Assessing non-routine information l Measuring effectiveness:
– Outcome (versus process) variables – Medical services activities
l Integration of data arising from: – Real time timelines – Point of use in services organizations – Multiple countries
Safety-Related Information Systems Risk Management
John Clark, MD, MSPH PCSglobal
740 Bethlehem Pike Flourtown, PA 19034
(215) 510-4737 [email protected]