Program Scope
The scope of the GDP·UCI project is necessarily broad simply because the different aspects of GDP are all inter-related and any attempt at
compliance reform needs to take into account the knock-on effects of any changes introduced. It is also important that it reflects, and is flexible
enough to take into account of, important trends in the market such as the sustainability imperative or the increasing convergence of medicines
and medical devices into hybrid treatments.
Depth & Breadth
The inter-related nature of all the different facets of GDP means
that the amplitude of the GDP·UCI program is necessarily broad in
order to encompass all the operational aspects of GDP compliance
at a functional level.
The different aspects of GDP are intimately interlinked and any
attempt at compliance reform needs to take into account the
knock-on effects of any changes introduced. It is also important
that the GDP-UCI reflects, and is flexible enough to take into
account of, important trends in the market such as technical
advances, the sustainability imperative and the increasing
convergence of medicines and medical devices.
The GDP-UCI remit is, inter alia, one of harmonising the
interpretation of GDP guidance, introducing GDP-compliant
processes and solutions, synchronising and standardising GDP
training / auditing / certification etc. all based, wherever possible,
around a doctrine of collaboration and sharing.
The scale of challenge this represents is not underestimated which
is why the GDP·UCI is:
•
Courting continuous input from the field
•
Pursuing a step-by-step approach initially focused on
identified GDP 'pain-points’
•
Seeking working partnerships with congruous institutions
and relevant statutory authorities
Primary Work Groups
The GDP-UCI Primary Work Groups cover the following areas:
•
Training / Education
for consolidated and harmonised GDP training, both
practical and theoretical, at all levels and in all formats
•
Audit / Certification
for a systematic GDP certification scheme and shared
GDP audit programs
•
Guidance & Solutions
for standard GDP-compliant field solutions and other
practical tools
•
GDP Knowledge Bank
to assist with improved consistency in interpretation and
application of regulatory requirements
These are the initial areas of attention for the project.
Network Communications
At the very heart of the GDP-UCI is its on-line Collaboration Platform where all network communications and interactions take place. This dedicated
portal permits secure information sharing on a 24-7 basis between all GDP-UCI participant organisations wherever they may be located in the world.
The Collaboration Platform plays an absolutely vital part in the GDP-UCI by facilitating network communications/virtual meetings, the exchange of
ideas, the dissemination of news, the sharing of information and the management of projects.
The GDP-UCI Collaboration Platform provides many benefits:
•
Offers a secure central hub for all GDP-UCI comms, news and activities
•
Facilitates collaboration across global locations and time zones
•
Reduces the need for emails and meetings
•
Provides ‘always on’ communications between GDP-UCI members and officers
•
Presents a neutral space of shared GDP-UCI values, goals and culture
•
Keeps the acquisition, analysis and sharing of sensitive/proprietary information easy and secure
•
Provides ‘on the go’ smartphone connection for 24-7 network access
•
The home of the GDP-UCI Knowledge Bank and a place to get GDP-UCI documentation and answers to your GDP questions
•
Fully customised notifications and alerts to suit individual needs and preferences
•
Polling and survey utilities to collect information, opinions and choices
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