Pamela Williamson-Joyce

Paul Lammers (left), chief medical officer; Stuart Grant, chief financial officer; and Pamela Williamson Joyce, VP, regulatory affairs and quality assurance, are top members of Seronos US management team leading the companys push into the US market.

Pamela Williamson Joyce, vp of regulatory affairs and quality assurance at Serono (www.serono. com), cites legal/regulatory changes such as the 1997 FDA Modernization Act for helping to push drugs through the regulatory process.

Paul Lammers (left), chief medical officer; Stuart Grant, chief financial officer; and Pamela Williamson Joyce, VP, regulatory affairs and quality assurance, are top members of Seronos US management team leading the companys push into the US market.

Paul Lammers (left), chief medical officer; Stuart Grant, chief financial officer; and Pamela Williamson Joyce, VP, regulatory affairs and quality assurance, are top members of Seronos US management team leading the companys push into the US market.

Industry BIO: Pamela Williamson Joyce , A 25-year veteran at Serono, Pamela Williamson Joyce, VP, Regulatory Affairs & Quality Assurance, has witnessed the transformation of an industry.Having spent her entire regulatory career at Serono, she knows a thing or two about the challenges a company faces when navigating the road toward FDA approval.The company has nine products on the market in four therapeutic areas, and she has played a vital part in moving these drugs through the approval process.

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Pamela Williamson-JoyceVice President, Regulatory Affairs
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Pamela Williamson-Joyce, Vice President, Regulatory Affairs & Quality Assurance at Serono explains short and long term impacts of the risk-based paradigm.

Pamela Williamson-Joyce Vice President Regulatory Affairs & Quality Assurance

"They were so happy that we had filed electronically that they were actually willing to give us some extra time to revise the submission without penalizing us on the clock," says Pamela Williamson Joyce, VP of regulatory affairs and quality assurance.Serono hired Image Solutions of Whippany, NJ, to help get the filing into shape."They helped us in doing the reformatting and interpreting some of the lingo that was in the guidances," Joyce explains."Basically, they QC'd and made heavy corrections."

Serono has now begun filing NDAs, BLAs, and supplements electronically, using an XML backbone adapted from a platform originally developed as a publication repository.The cost of the work, done in-house, ran into the hundreds of thousands of dollars.The company also has gained the expertise to do all of the necessary formatting, bookmarking, and hyperlinking internally.One side benefit, Joyce notes, is that learning these skills is a lot more interesting for employees than running a copier and collating massive quantities of paper."There's a benefit in terms of job satisfaction and employee retention."