Implementation of Structured Benefit-Risk Assessments in Marketing Authorization Applications: Lessons Learned

2016 ◽  
Vol 50 (6) ◽  
pp. 718-723 ◽  
Author(s):  
JuAn Wang ◽  
Anne Wolka ◽  
Kristin Bullok ◽  
Greg Anglin ◽  
Christine Radawski ◽  
...  
Keyword(s):  
Lessons Learned ◽  
Risk Assessments ◽  
Marketing Authorization

Industrial Implementation of Risk Based Inspection Planning Lessons Learnt From Experience: Part 1 — The Case of FPSOs

2004 ◽  
Author(s):  
Jean Goyet ◽  
Antoine Rouhan ◽  
Michael Havbro Faber
Keyword(s):  
Offshore Structures ◽  
Lessons Learned ◽  
Risk Assessments ◽  
Structural Components ◽  
Inspection Planning ◽  
Industrial Implementation ◽  
Lessons Learnt ◽  
Specific Risk ◽  
Planning Methods

This paper is the first part of a report dealing with industrial implementation of Risk Based Inspection planning methods to offshore facilities. The first part deals with FPSO/FSO while the second deals with fixed steel offshore structures. The objective of the report is to convey “lessons learned” from experience using RBI methods. Theses methods aim at establishing inspection planning based on optimization procedures derived from specific risk assessments. Experience of the three authors is based on the last methodological developments in the area of RBI planning for structural components subject to fatigue degradation and on application of these methods to various types of offshore facilities. The main steps of the RBI methodology are summarized in the first paper. General conclusions related to the two types of facilities are given at the end of the second paper.

Ecology, statistics, and the art of misdiagnosis: The need for a paradigm shift

1999 ◽  
Vol 7 (4) ◽  
pp. 167-190 ◽  
Author(s):  
J D Germano
Keyword(s):  
Risk Assessment ◽  
Paradigm Shift ◽  
Ecosystem Health ◽  
Statistical Significance ◽  
Lessons Learned ◽  
Risk Assessments ◽  
Ecological Data ◽  
Marine Monitoring ◽  
The Past ◽  
Alternative Approaches

This paper approaches ecological data analysis from a different vantage point and has implications for ecological risk assessment. Despite all the advances in theoretical ecology over the past four decades and the huge amounts of data that have been collected in various marine monitoring programs, we still do not know enough about how marine ecosystems function to be able to make valid predictions of impacts before they occur, accurately assess ecosystem ``health,'' or perform valid risk assessments. Comparisons are made among the fields of psychology, social science, and ecology in terms of the applications of decision theory or approach to problem diagnosis. In all of these disciplines, researchers are dealing with phenomena whose mechanisms are poorly understood. One of the biggest impediments to the interpretation of ecological data and the advancement of our understanding about ecosystem function is the desire of marine scientists and policy regulators to cling to the ritual of null hypothesis significance testing (NHST) with mechanical dichotomous decisions around a sacred 0.05 criterion. The paper is divided into three main sections: first, a brief overview of common misunderstandings about NHST; second, why diagnosis of ecosystem health is and will be such a difficult task; and finally, some suggestions about alternative approaches for ecologists to improve our "diagnostic accuracy'' by taking heed of lessons learned in the fields of clinical psychology and medical epidemiology. Key words: statistical significance, Bayesian statistics, risk assessment

scholarly journals Integration of lessons learned from 30 years of oil on water exercises, testing and training in an improved industry oil spill contingency framework

2021 ◽  
Vol 2021 (1) ◽  
Author(s):  
G. M. Skeie ◽  
I. S. Kristoffersen ◽  
F. Engen ◽  
P. M. Sævik ◽  
H. Lura ◽  
...  
Keyword(s):  
Oil Spill ◽  
Lessons Learned ◽  
Risk Assessments ◽  
Assessment Methodology ◽  
Response Planning ◽  
Oil Spill Response ◽  
Water Exercises ◽  
Norwegian Continental Shelf ◽  
And Training ◽  
Exploration Activity

ABSTRACT On behalf of the operators on the Norwegian Continental Shelf, the Norwegian Clean Seas Association for Operating Companies (NOFO) has the responsibility for providing a documented and verified level of oil spill response, fulfilling the requirements set by the regulatory authorities for each individual production and exploration activity. To meet this responsibility and document the established oil spill preparedness, a comprehensive and cross-disciplinary project has been undertaken, integrating results and lessons learned from oil on water exercises and test facilities in the period 1985 to 2018. The structured results feed into standardized algorithms for system capability and operational windows, applicable across all combat methods in the NOFO toolbox. Through gap and sensitivity assessments, topics for R & D area prioritisation are identified. Data and information are structured in order to fit into the assessment methodology for Environmental Risk Assessments (ERA) and Spill Impact Mitigation Assessments (SIMA), and a step by step methodology for oil spill response assessments (OSRA) was developed as part of the project, facilitating standardised and comparable oil spill response plans. In addition to this standardisation and documentation process, templates for presentation of key data for oil spill response planning purposes are developed, and disseminated to a dedicated web site, as well as the NOFO Common Operating Picture GIS. In this way, a cohesive set of data and standards are available for use in assessments, planning, authority assessment and in incidents.

scholarly journals Lessons learned from rapid environmental risk assessments for prioritization of alien species using expert panels

2019 ◽  
Vol 249 ◽  
pp. 109405 ◽  
Author(s):  
L.N.H. Verbrugge ◽  
L. de Hoop ◽  
R. Aukema ◽  
R. Beringen ◽  
R.C.M. Creemers ◽  
...  
Keyword(s):  
Alien Species ◽  
Environmental Risk ◽  
Lessons Learned ◽  
Risk Assessments

Lessons Learned From Coaching Postsecondary Students With Traumatic Brain Injury

2020 ◽  
Vol 5 (1) ◽  
pp. 88-96
Author(s):  
Mary R. T. Kennedy
Keyword(s):  
College Students ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Sense Of Self ◽  
Scientific Evidence ◽  
Sudden Onset ◽  
Lessons Learned ◽  
Speech Language Pathologists ◽  
The Brain ◽  
Exhaustive List

Purpose The purpose of this clinical focus article is to provide speech-language pathologists with a brief update of the evidence that provides possible explanations for our experiences while coaching college students with traumatic brain injury (TBI). Method The narrative text provides readers with lessons we learned as speech-language pathologists functioning as cognitive coaches to college students with TBI. This is not meant to be an exhaustive list, but rather to consider the recent scientific evidence that will help our understanding of how best to coach these college students. Conclusion Four lessons are described. Lesson 1 focuses on the value of self-reported responses to surveys, questionnaires, and interviews. Lesson 2 addresses the use of immediate/proximal goals as leverage for students to update their sense of self and how their abilities and disabilities may alter their more distal goals. Lesson 3 reminds us that teamwork is necessary to address the complex issues facing these students, which include their developmental stage, the sudden onset of trauma to the brain, and having to navigate going to college with a TBI. Lesson 4 focuses on the need for college students with TBI to learn how to self-advocate with instructors, family, and peers.

Experiences With and Lessons Learned From Developing, Implementing, and Evaluating a Support Program for Older Hearing Aid Users and Their Communication Partners in the Hearing Aid Dispensing Setting

2020 ◽  
Vol 29 (3S) ◽  
pp. 638-647 ◽  
Author(s):  
Janine F. J. Meijerink ◽  
Marieke Pronk ◽  
Sophia E. Kramer
Keyword(s):  
Large Scale ◽  
Hearing Aid ◽  
Critical Discussion ◽  
Lessons Learned ◽  
Research Note ◽  
Support Program ◽  
Large Sample Size ◽  
Long Term Effects ◽  
Communication Program ◽  
Communication Partners

Purpose The SUpport PRogram (SUPR) study was carried out in the context of a private academic partnership and is the first study to evaluate the long-term effects of a communication program (SUPR) for older hearing aid users and their communication partners on a large scale in a hearing aid dispensing setting. The purpose of this research note is to reflect on the lessons that we learned during the different development, implementation, and evaluation phases of the SUPR project. Procedure This research note describes the procedures that were followed during the different phases of the SUPR project and provides a critical discussion to describe the strengths and weaknesses of the approach taken. Conclusion This research note might provide researchers and intervention developers with useful insights as to how aural rehabilitation interventions, such as the SUPR, can be developed by incorporating the needs of the different stakeholders, evaluated by using a robust research design (including a large sample size and a longer term follow-up assessment), and implemented widely by collaborating with a private partner (hearing aid dispensing practice chain).

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