Využítí STAMP ve vývoji léčiv

27. july 2015 at 8:00 | Veronika Valdova (@AreteZoe) |  Risk Management
STAMP ve vývoji léčiv

STAMP is based on systems theory and accounts for:
•Complex human decision making
•Organizational and managerial aspects of systems (safety culture, management decisions)
•Adaptation of systems over time (migration toward hazardous states)

Most hazard analysis techniques focus on failure events.
Principle: identifying the failure events that can lead to a hazard.
•Most popular: Fault Tree Analysis (FTA) & Failure Modes and Effects Criticality Analysis (FMECA)
•Clinical research and post-market drug safety: record of past incidents (ADR reporting systems, i.e. FAERS, EudraVigilance, WHO Vigibase)

In system accidents the losses stem from dysfunctional interactions among operating components rather than failure of individual components.
•In STAMP, the cause of an accident is viewed as the result of a lack of constraints imposed on system design and operations rather than an event.
•The objective is to identify the design constraints necessary to maintain safety and to ensure that the system design and operation enforces these constraints.

Utilizing STAMP to create control structure of selected critical points in drug development, approval and commercialization on the example of TeGenero case study to explore the usability of STAMP in the Pharmaceutical Industry.Can drug development timelines be compressed while increasing regulatory confidence that public health interests and protections also advance? For the answer to be affirmative, biotech and pharmaceutical companies need to focus their attention to hazard identification and implementation risk management techniques. This proposal builds on presentation Global Pharma, risk analysis primer: An intentional interaction with uncertainty.

System Theoretic Accident Model and Processes (STAMP) will be used to construct control structure of individual critical incidents in two case studies: TeGenero, as an example of a First-In-Man Trial, and Avandia,a post-market surveillance study.

The potential benifits of utilization of STAMP to enhance quality and consistency of regulatory review will be explored as well.

TeGenero studie

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