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Regulatory consultant joins ISI European office

Image Solutions : 23 June, 2008  (Company News)
New hire in the UK to oversee the implementation of compliance and regulatory projects for Image Solutions' growing European market
Image Solutions (ISI) has announced the appointment of Kate Wilber, formerly Senior Manager for Global Regulatory Operations at Shire Pharmaceuticals, to a senior role within its Regulatory Consulting practice, further bolstering ISI's growing European business.

A US national based in England, Kate joins ISI (UK) Limited, the wholly-owned subsidiary of ISI Inc, where her role will be to provide business process expertise and advice to ISI's clients on an international basis. She will report to Toban Zolman, ISI's Director of Consulting Services.

At Shire Pharmaceuticals, Kate headed up a cross-functional eCTD implementation team, a role which involved collaborating with external consultants to define global eCTD metadata standards; addressing training needs throughout regulatory affairs as well as across R&D; and managing multiple major submission publishing teams for both US and EU applications. The role also included the implementation of ISI's eCTDXPress, ISIPublisher and ISIRegTracker business applications.

In her new position as Senior Regulatory Consultant at ISI, which she will assume on July 7th, Kate will operate within the UK business's professional services organisation, where she will be responsible for delivering advisory, best practices, analysis and execution-related support within regulatory operations consulting projects. She will also be responsible for operational activities, project management of on-site client projects including submission management, RA and line-function relations.

Commenting on the appointment, Adam Sherlock, ISI's UK Managing Director, said: "This is fantastic news for ISI and our customers. Kate brings a wealth of knowledge and experience of the regulatory publishing and submission business process, in all output formats, and to all major agencies on a global basis. Her know-how will be invaluable in assisting ISI's clients to optimise their regulatory business operations and maximise the benefit they can derive from implementing ISI software and services. We welcome her on board."

Prior to joining Shire, Kate worked at Liquent for three years, most recently as a Product Manager for the publishing solutions business. She graduated with a Bachelor of Science degree in Mathematics from Dickinson College in Carlisle, Pennsylvania.
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