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Event

The Hay-Team – Raleigh NC

Our primary packaging capabilities feature scalable options to meet the varying needs of each trial, from small Phase I studies to the largest Phase III and Phase IV programs.

In 1998, a crack team of pharmaceutical packers were sent to Mid-Wales to provide a higher service than anyone else could commit to!
Today, these people still provide that industry leading customer experience.
If you have primary packaging challenges, and if you want the best in the business…
Maybe you should hire The Hay-Team

Agenda

10:00 – 10:30am Registration

10:30 – 10:40am Welcome and Introduction

10:40 – 11:20am FACE – Full package design requirements and pitfalls for clinical, while thinking about European commercialization and design
Paul Smallman, Director Technical Services
Asthetics can be everything, and we know that not everything was designed to look like Dirk Benedict. Late phase clinical trial package design can be a tightrope of walking between therapeutical disadvantages such Parkinson’s, regulatory stipulations such as Child Resistance and furthermore thinking about marketing and commercialization into Phase III and beyond. PCI’s key European Package design team talk about catering pack design for populations in over 28 countries, dealing with complex titration regimens while focusing on those all important safety, efficacy and value inflection points.

11:20 – 12:00pm B.A – BREXIT – Fact Versus Fiction
Tristram Evans, Director, Global Clinical Services Quality and QP
“It is very hard for anybody not intimately involved with the European Union, the workings of the UK economy and the healthcare sector to clearly understand the true facts or indeed the advantages and disadvantages of Brexit. One fact is clear, Brexit is happening in March 2019 and the UK will leave the European Union.

So what does Brexit mean for the pharmaceutical sector? With European Commission directives and cross-border collaborations currently in place, it is perceived that clinical supply chains will experience future challenges in terms of compliance with new rules and regulations that will be enforced post March 2019.

With the degree of ‘Brexit uncertainty’ appearing to be increasing, what is fact and what is fiction and what will be the impact on the pharmaceutical sector?”

12:20 – 12:10pm Coffee Break

12:10 – 12:45pm Murdoch – Customs and tax the unpredictable madness
David Spillett, Global Account Director, World Courier
Ex-US Studies can be daunting for any size Pharma company. From questions such as ‘Do I need a UK Entity to claim VAT back’ through to unpredictable goods valuation in non European countries. World Courier will walk you through the many aspects of non US import and exportation, ensuring that you have A-Team grade knowledge to walk away with.

12:45 – 1:25pm Hannibal – We Love it when a plan comes together.
Colin White, MD Hay on Wye
When is a European Depot not a depot?… When it can also package to help you cut your timelines! Colin White, Managing Director of PCIs Hay, UK Facility talks us through the options and cost benefit analysis of packaging either solely in the UK, or having a site in addition to your US hub with which to package from, including what size of study this suits, how this effects overall study timelines and being able to reach that FPI Date, in order to hit your critical milestone. Colin looks at a factual case study involving financial analysis and practical thoughts with which to plan your global study.

1:25 – 3:00pm Close out, networking and lunch

To register for this event, please click here:

Date & Time

1 Feb 2018 - 10:00 am - 3:00 pm

Location

Embassy Suites by Hilton Raleigh Durham Research Triangle
201 Harrison Oaks Blvd
Cary
NC
27513
United States

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