Patricia Santos-Serrão
RAC Regulatory Advisor
Last Post: 19 Days Ago
Number of Posts: 8
Number of Comments: 2
Patrícia Santos-Serrão is a Regulatory Advisor in the Life Sciences practice at QUMAS with focus on Clinical and Regulatory Affairs processes. She has been in the Life Sciences industry since 1994 starting her career at Schering-Plough in Kenilworth, NJ, and later joining Boehringer Ingelheim Pharmaceutical in Ridgefield, CT, both in RA. Having had experience with global submissions both paper and electronic over eight years, Santos-Serrão moved into the solutions provider sector joining CDC Solutions, which was later acquired by Liquent, and CSC as a Business Process Specialist and Regulatory Specialist. She has assisted various customers during her time at CDC Solutions, Liquent and CSC in compiling eCTDs, and other submission format filings worldwide.
2008 - The Year of the eCTD
Posted: 119 days ago
The New Year is now upon us, and with the New Year comes a number of new requirements as well as misunderstandings regarding these new requirements. Everyone in the Regulatory Affairs area of Life Sciences has heard about the new initiative that started on January 1, 2008 pertaining to…
Read MoreRisk Management: Importance of Labeling
Posted: 125 days ago
In 2007, the importance of drug labeling in the safety of patients has received national attention. The tabloids as well as well respected news programs covered in detail an incident involving the newborn twins of Hollywood actor Dennis Quaid. The Quaid twins were victims of an accidental overdosing…
Read MorePresentation: The Importance of Document Management When Designing a GRSD
Posted: 166 days ago
You are invited to join me at the upcoming RAPS Regulatory Strategy Forum in Atlanta, GA. l will be speaking on “The Importance of Document Management When Designing a GRSD” at the Regulatory Affairs Professional Society (RAPS) Regulatory Strategy Forum: Tools for Designing a Global Regulatory Strategy Document (GRSD)…
Read MoreLooming eCTD deadline....are you ready?
Posted: 291 days ago
If you are like me, you’ve been hearing about eCTD for years. While some have maintained steadfastly (and in denial) that eCTD will never be a mandatory standard, others feel differently. However you feel about it, the issue has been decided and the future is here. The FDA announced that…
Read MoreNew Year's Resolution
Posted: 494 days ago
For centuries, we’ve been using the arrival of a new year as an excuse to take a hard look at ourselves and resolve to make improvements. Now that 2007 is here, it’s the perfect time to apply that same logic to your compliance program and commit to some New Year’s…
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