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News

New hire joins European regulatory services team at ISI

Image Solutions : 21 April, 2009  (Company News)
ISI's expansion plans for the European regulatory market bolstered with appointment of experienced consultant
Image Solutions (ISI) is continuing its European expansion with the appointment of Jennie May to its Regulatory Services team.

Jennie May, who joined the company mid March, will provide regulatory consultancy services to ISI's clients across Europe, helping them to design and implement best-practice business processes for electronic regulatory submission publishing and regulatory information management. She will report directly to Kate Wilber, ISI's director of regulatory services, Europe.

Jennie joins from Hospira (formerly Mayne Pharma) where she worked in for eight years within the European Regulatory Affairs team. Her most recent position, as Regulatory Operations Manager, included responsibility for managing regulatory operations, MRP, DCP & CP submissions, variations, renewals, participating in an electronic submissions working group, managing regulatory budgets, and providing business support during the evaluation of publishing and authoring software for eCTD. Most recently she was the primary business lead in a global registration tracking system implementation.

ISI's European operations are expanding at an accelerating pace as international pharmaceutical companies grapple with the complexities caused by the adoption of the electronic Common Technical Document (eCTD) standard for regulatory submissions. While the standard has been bedded down in the US, adoption policies and timelines vary considerably across the European Union, increasing the administrative burden on firms targeting multiple countries. This has led to a rise in demand for ISI's multi-format submission solutions, which enable companies to comply with the varying demands of each market, fully embracing eCTD wherever possible.

"We are very excited to have Jennie on board," commented Kate Wilber, director of regulatory services, Europe, ISI. "Her experience will be of huge value to ISI and our clients as we make further in-roads into this sector with our ISIRegTracker software. This helps organisations keep on top of changes to registrations in global markets, search and manage approval applications, and effectively manage product variations, safety updates and product renewals - vital as they navigate their way through Europe's complex submissions environment."

"Jennie will be a valuable asset to ISI in Europe as our business here continues to go from strength to strength," said ISI's European MD Adam Sherlock. "We want to extend a warm welcome to her, with full assurance that the role ahead will be a busy and fulfilling one."

Jennie lives in Warwick, in the UK.
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