Minimising time to clinic by maximising smart, efficient processes
Join PCI Clinical Services and Medicon Valley Alliance at the upcoming Good Morning Meeting and explore the best practices to engage to get your investigational products in the clinic quicker.
Date: November 22nd, 2016
Time: 8:30 – 11:00
Address: Arne Jacobsens Allé 15, 2300 Copenhagen S
Room: Ground floor
Join us for our Good Morning Meeting and hear from the experts from PCI.
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PROGRAM
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08:30
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Registration and Breakfast
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08:50
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Welcome
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09:00
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Fast Track Packing: Handling Adaptive Clinical Trial Designs and Maximising Efficiencies
Samantha James, Associate Director Clinical Operations, PCI
Traditionally the end to end clinical trials packaging process touches a number of different departments and people
with the standard for the turnaround of such projects being anything between 4 to 8 weeks. However, there is an
increasing need for rapid packing, labelling and distribution in clinical trials coupled with the need to maintain
flexibility of the drug product. The session will address how Fast Track can be beneficial during smaller trials where
data is needed as quickly as possible and there will be a review into JiT and how it can reduce cost when running
two parallel studies with one or more of the same drugs and look at the innovative and unique methods Fast Track
employs to deliver compliant Clinical Trial supplies, for time-critical studies, in the shortest possible time, without
compromising on quality.
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09:30
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Speed to Clinic verses Patient Compliance
Paul Smallman Director, Technical Services, PCI
In a time where time is of the essence, speed to clinic should not be at the expense of poor packaging design.
By looking ahead and forward planning your packaging partner and dosing strategy, high compliance packaging
solutions are possible. Even with reduced start up times for both oral dose and parenteral formats and at a
multitude of packaging and storage conditions including but not limited to ambient, 2˚C to 8˚C, -20˚C and -40˚.
Find out how.
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10:00
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Annex 16 Update and Impact
Beth Halliday, QP, PCI Pharma Services
Annex 16, Certification by a Qualified Person and Batch Release, came into operation on 15 April 2016. The
Annex has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction
of new quality control strategies. It also incorporates the requirements of the Falsified Medicines Directive and
implements the ICH Q8, Q9 and Q10 documents. This talk seeks to highlight some of those changes and their
impact on QPs, clients and manufacturers.
In particular we will examine the impact of:
– supply chain complextixity, documentation and audit requirements
– QP Certification of Partial Manufacturing
– Sampling in a 3rd country and technical justification requirements
– Relying on 3rd Party GMP Assessments
– Deviation handling when faced with a licence non compliance
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10:30
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Networking and Coffee
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In cooperation with: |
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