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POSTER ABSTRACTS
development authority, BARDA strengthens HHS efforts to bridge the valley of
death funding gap that exists between the early stages of product development
and the acquisition of approved or approvable medical countermeasures for the
Strategic National Stockpile (SNS). BARDA advanced development programs
support efforts to develop therapeutics to treat sub-syndromes of acute radiation
syndrome as well as decorporation agents. More recently, BARDA is beginning
a new initiative to support development of blood products and blood product
platform technologies, including but not limited to cellular therapies, plasma
products, and platelet products, to bolster existing preparedness and response
resources and tools. BARDA is also developing biodosimetry tools, both devices
and assays.
169
QUALITY CULTURE AND TOOLS: SYNERGY FOR COMPLIANCE
AND ACCREDITATION
Nancy M Messino, Aimee E Stewart, Sally Anderson, Royal Children’’s Hospital, Melbourne,
Australia.
In accordance with best practice and international standards, the Haemopoietic
Stem Cell Transplant (HSCT) Programme of the Children’s Cancer Centre (CCC)
at the Royal Children’s Hospital (RCH), Melbourne, Australia, decided to obtain
FACT Accreditation. Aims of accreditation include;
•A Quality Management Plan with functional robust quality systems providing a
framework for clinical, collection and laboratory services provided by the HSCT
Programme.
•Compliance with both international and legislated national benchmarks.
While in general the RCH participates in the ACHS (Australian Council of HealthCare
Standards) accreditation system to ensure quality of clinical care, the CCC made the
strategic decision that a higher level of quality management was required to support
the HSCT Programme. A position was created to develop, implement and monitor
quality management systems for all HSCT services and attain FACT accreditation.
In collaboration with the managers of individual services, a comprehensive review
and gap analysis was undertaken across the HSCT Programme. While the laboratory
service was at an advanced level of compliance with national regulatory requirements
as assessed by NATA (National Association of Testing Authorities), the clinical and
collection services were commencing the quality journey.
Following an assessment of the available quality management tools, it was decided
to implement Q-Pulse software to support the introduction of a more stringent
quality culture and provide mechanisms for capturing data about all quality functions
being performed. The software’s flexibility facilitated the introduction, and allowed
for customization, of a compliant quality management system. Individual software
modules were tailored for document control, opportunities for improvement, nonconformance reporting, audit, and supplier and equipment management.
The implementation of Q-Pulse software has proven to be an effective quality
management strategy, providing the delivery of compliance and attainment of
accreditation by governing bodies. Therefore this solution could be utilized to solve
similar challenges in other facilities.
170
FROM REACTIVE TO PROACTIVE: THE QUALITY MANAGEMENT
MATURITY MODEL
Nicole Bleasdale, Maria Maroulis, Patrick Coghlan, Dr, Australian Red Cross Blood Service,
Melbourne, Australia.
Since 1999 the Australian Red Cross Blood Service has assisted biological
manufacturing organisations with the implementation and improvement of
their quality management systems in the fields of blood and blood component
manufacture, tissue banking, cellular therapies and clinical trials management.
More recently (since 2008), the Blood Service has applied its expertise towards
assisting 9 institutes across Australia engaged in early phase clinical cellular
therapies/regenerative medicine projects to develop and implement quality
management systems and achieve cGMP compliance.
Through our experience we have observed a correlation between the maturity of
an organisation and its approach to quality management. Organisations in their
early stages of development, such as research groups entering the translational
research phase, are commonly unaware of the requirements and benefits of
quality management and tend to take a reactive approach to quality issues. In
contrast, mature organisations take a proactive approach and integrate quality
management into all their activities.
A Risk Management Maturity Model (RMMM) developed in 2002 through a
formal collaboration between the International Council on Systems Engineering
Risk Management Working Group, the Project Management Institute Risk
Management Specific Interest Group, and the UK Association for Project
Management Risk Specific Interest Group defined four distinct levels of maturity:
Ad Hoc, Initial, Repeatable and Managed. Each level includes recommended
actions needed to move to the next level of maturity.
We recognise that this RMMM framework is readily applicable to the
implementation of quality management. As such we have adapted the RMMM to
develop a Quality Management Maturity Model (QMMM). The QMMM enables
us to categorise each client’s approach to quality management and identify the
actions necessary to achieve the next maturity level. The overall intent of this
model is to provide a tool to enable a considered, step-wise and timely approach
to implementing quality management.
171
POLICIES REGARDING HUMAN GENETIC MODIFICATION
TECHNOLOGIES IN MEXICO
Isaac O. Osadolor, MD; M.Sc; PhD; D.Sc.1,2 Magdalena Guadalupe S. Rodriguez, PhD3,4
1
Instituto de Ciencias Jurídicas de Puebla A.C., Puebla, Puebla., Mexico, 2Universidad
Popular Autónoma del Estado de Puebla, Puebla, Mexico, 3Universidad Autónoma de
Tlaxcala Facultad de Ciencias de la Salud Licenciatura en Médico Cirujano., Tlaxcala, Mexico,
4
Instituto Tlaxcalteca de Asistencia Especializada a la Salud , Tlaxcala, Mexico.
Mexican federal legislation does not regulate explicitly human genetic modification.
The General Health Law (GHL) and its Regulation on Scientific Research (RSR)
and Regulation on the Sanitary Control of Organs, Tissues and Human Cadavers
(RCOTHC), have been interpreted as implicitly prohibiting human germline
modification. Research on embryos can only be conducted for the benefit of
the embryo and then only when their “security/integrity is guaranteed,” (Art.
56). For the purpose of this law, an embryo is “the product of conception from
fertilization to the end of the week of gestation” (Art. 314). This definition is
consistent with the Regulation of the General Health Law on Scientific Research.
The aforementioned legislation regulates the use of human cells and embryos.
The only legal norm contemplating human genetic modification is the Penal Code
for the Mexican Federal District (CPDF). According to article 154 of the CPDF, the
crime of “genetic manipulation” is committed when a person (i) “with a purpose
other than eliminating or diminishing serious diseases or disorders manipulates
human genes in such a way that alters a genotype; (ii) fertilizes a human egg with a
different purpose than human procreation; or (iii) creates human beings by cloning
or performs genetic engineering with illicit purposes” (Art. 154). The disposition of
germinal cells is considered to be illicit when it is performed against the purposes
for which the donor(s) has granted authorization (Art. 149). Furthermore, Art.
155 establishes that if a child is born in contravention of the above mentioned
provisions, the compensation of damages includes the payment of child support
to the mother. There is no specific federal or local legislation dealing with somatic
human modification or gene therapy; hence it is governed by the general provisions
related to human experimentation and scientific research (Arts. 100 and 465GHL,
Arts. 13 and 14RSR).
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