scholarly journals Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products

Materials ◽  
2020 ◽  
Vol 13 (20) ◽  
pp. 4532 ◽  
Author(s):  
Elisa Giubilato ◽  
Virginia Cazzagon ◽  
Mónica J. B. Amorim ◽  
Magda Blosi ◽  
Jacques Bouillard ◽  
...  
Keyword(s):  
Risk Management ◽  
Medical Devices ◽  
Medical Diagnostics ◽  
Life Cycles ◽  
Environmental Risks ◽  
Medicinal Products ◽  
Management Framework ◽  
Advanced Therapy Medicinal Products ◽  
Risk Management Framework ◽  
Advanced Therapy

The convergence of nanotechnology and biotechnology has led to substantial advancements in nano-biomaterials (NBMs) used in medical devices (MD) and advanced therapy medicinal products (ATMP). However, there are concerns that applications of NBMs for medical diagnostics, therapeutics and regenerative medicine could also pose health and/or environmental risks since the current understanding of their safety is incomplete. A scientific strategy is therefore needed to assess all risks emerging along the life cycles of these products. To address this need, an overarching risk management framework (RMF) for NBMs used in MD and ATMP is presented in this paper, as a result of a collaborative effort of a team of experts within the EU Project BIORIMA and with relevant inputs from external stakeholders. The framework, in line with current regulatory requirements, is designed according to state-of-the-art approaches to risk assessment and management of both nanomaterials and biomaterials. The collection/generation of data for NBMs safety assessment is based on innovative integrated approaches to testing and assessment (IATA). The framework can support stakeholders (e.g., manufacturers, regulators, consultants) in systematically assessing not only patient safety but also occupational (including healthcare workers) and environmental risks along the life cycle of MD and ATMP. The outputs of the framework enable the user to identify suitable safe(r)-by-design alternatives and/or risk management measures and to compare the risks of NBMs to their (clinical) benefits, based on efficacy, quality and cost criteria, in order to inform robust risk management decision-making.

Nanomaterials in Medical Devices: Regulations' Review and Future Perspectives

2021 ◽  
pp. 1910-1917
Author(s):  
Karolina Jagiello ◽  
Anita Sosnowska ◽  
Alicja Mikolajczyk ◽  
Tomasz Puzyn
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Risk Analysis ◽  
Medical Devices ◽  
Future Perspectives ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Probability Of Occurrence ◽  
Advanced Therapy ◽  
Related Harm

This article gives a brief description of the existing regulations related to biomaterials safety that need to be considered before it is introduced into EU market. According to these regulations, the risk analysis should include two characteristics: probability of occurrence of harm, and severity. Identified user-related harm should be reduced by managing the risk. Additionally, the review presents an overview of engineered biomaterials (EBMs), which in combination with nanoscale components (NPs) have shown promises in Advanced Therapy Medicinal Products (ATMP) and Medical Devices (MD). In this article, recent challenges, objectives and perspectives in risk assessment and risk management of ATMP and MD composed of nanobiomaterials were also highlighted.

Nanomaterials in Medical Devices: Regulations' Review and Future Perspectives

2017 ◽  
Vol 2 (2) ◽  
pp. 1-11
Author(s):  
Karolina Jagiello ◽  
Anita Sosnowska ◽  
Alicja Mikolajczyk ◽  
Tomasz Puzyn
Keyword(s):  
Risk Assessment ◽  
Risk Management ◽  
Risk Analysis ◽  
Medical Devices ◽  
Future Perspectives ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Probability Of Occurrence ◽  
Advanced Therapy ◽  
Related Harm

This article gives a brief description of the existing regulations related to biomaterials safety that need to be considered before it is introduced into EU market. According to these regulations, the risk analysis should include two characteristics: probability of occurrence of harm, and severity. Identified user-related harm should be reduced by managing the risk. Additionally, the review presents an overview of engineered biomaterials (EBMs), which in combination with nanoscale components (NPs) have shown promises in Advanced Therapy Medicinal Products (ATMP) and Medical Devices (MD). In this article, recent challenges, objectives and perspectives in risk assessment and risk management of ATMP and MD composed of nanobiomaterials were also highlighted.

Developing and implementing the risk management framework into business processes of Gazprom transgaz Tomsk Ltd., for implementation of the Eastern gas program of PJSC Gazprom

2020 ◽  
Vol 17 (1) ◽  
pp. 68-77
Author(s):  
V. E. Zaikovsky ◽  
A. V. Karev
Keyword(s):  
Risk Management ◽  
Human Resources ◽  
Management Information System ◽  
Business Processes ◽  
Project Success ◽  
Management Information ◽  
Timely Manner ◽  
Project Approach ◽  
Management Framework ◽  
Risk Management Framework

Project success depends on the ability to respond to risks and make correct decisions in a timely manner. The project approach provides a better framework for implementing a new management system into the company’s business processes. The risk management framework developed by the company comprises a risk management infrastructure, a set of standards, human resources, and a risk management information system. To improve staff compliance, it is necessary to provide training and to communicate the goals of the project effectively. It is also important to develop a motivation system because well trained and motivated staff are able to work more efficiently.

scholarly journals Systematic Review: Allogenic Use of Stromal Vascular Fraction (SVF) and Decellularized Extracellular Matrices (ECM) as Advanced Therapy Medicinal Products (ATMP) in Tissue Regeneration

2020 ◽  
Vol 21 (14) ◽  
pp. 4982 ◽  
Author(s):  
Pietro Gentile ◽  
Aris Sterodimas ◽  
Jacopo Pizzicannella ◽  
Laura Dionisi ◽  
Domenico De Fazio ◽  
...  
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Stromal Vascular Fraction ◽  
Lateral Epicondylitis ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Advanced Therapy ◽  
Meta Analyses ◽  
Clinical Experiments

Stromal vascular fraction (SVF) containing adipose stem cells (ASCs) has been used for many years in regenerative plastic surgery for autologous applications, without any focus on their potential allogenic role. Allogenic SVF transplants could be based on the possibility to use decellularized extracellular matrix (ECM) as a scaffold from a donor then re-cellularized by ASCs of the recipient, in order to develop the advanced therapy medicinal products (ATMP) in fully personalized clinical approaches. A systematic review of this field has been realized in accordance with the Preferred Reporting for Items for Systematic Reviews and Meta-Analyses-Protocols (PRISMA-P) guidelines. Multistep research of the PubMed, Embase, MEDLINE, Pre-MEDLINE, PsycINFO, CINAHL, Clinicaltrials.gov, Scopus database, and Cochrane databases has been conducted to identify articles and investigations on human allogenic ASCs transplant for clinical use. Of the 341 articles identified, 313 were initially assessed for eligibility on the basis of the abstract. Of these, only 29 met all the predetermined criteria for inclusion according to the PICOS (patients, intervention, comparator, outcomes, and study design) approach, and 19 have been included in quantitative synthesis (meta-analysis). Ninety-one percent of the studies previously screened (284 papers) were focused on the in vitro results and pre-clinical experiments. The allogenic use regarded the treatment of perianal fistulas, diabetic foot ulcers, knee osteoarthritis, acute respiratory distress syndrome, refractory rheumatoid arthritis, pediatrics disease, fecal incontinence, ischemic heart disease, autoimmune encephalomyelitis, lateral epicondylitis, and soft tissue defects. The information analyzed suggested the safety and efficacy of allogenic ASCs and ECM transplants without major side effects.

Systems-based accident analysis in the led outdoor activity domain: application and evaluation of a risk management framework

Ergonomics ◽  
2010 ◽  
Vol 53 (8) ◽  
pp. 927-939 ◽  
Author(s):  
P. Salmon ◽  
A. Williamson ◽  
M. Lenné ◽  
E. Mitsopoulos-Rubens ◽  
C.M. Rudin-Brown
Keyword(s):  
Risk Management ◽  
Accident Analysis ◽  
Outdoor Activity ◽  
Management Framework ◽  
Risk Management Framework ◽  
Activity Domain
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