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October 15, 2012
Reduce Filing Time - Fast Turnaround of Innovator and BE First-to-File Analysis |
SPEAKER FOR THIS EVENT: 
Brigitte Pellerin, Senior Bioanalytical Project Manager, PharmaNet/i3  |
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Generic pharmaceutical companies allow the general public greater accessibility to medications at lower cost.
In addition, winning the race to become the first generic drug on the market (“first-to-file’) assures these generic companies a period of marketing exclusivity that is synonymous with substantial financial benefits. In order to be the best partner for their sponsors in such endeavors, CROs must be prepared to take on the challenges associated with first-to-file applications. These include: quick IRB and CTA approval, efficient recruiting of study participants and swift conduct of the clinical, bioanalytical and statistical phases. For an innovative drug company, fast turnaround of analysis is also critical when they choose to partner with a CRO as results are often required to undertake the next phase of the clinical trial.
In order to meet such expectations for timely and cost effective bioanalysis from several sponsors simultaneously, CROs must put in place specific strategies that include strong planning (before and during the trial), seamless communication, flexible schedule and capacity, dedicated resources, online quality activities and a strong commitment to the client. In this presentation, I will discuss the appropriate tools and technologies that need to be in place to assure efficient processes and delivery of fast, high quality data, key to meeting and surpassing client expectations for a successful bioanalytical program. |
This webinar is Part of a series about innovative approaches and specialized techniques to bioanalytical studies
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| THIS PROGRAM IS INTENDED FOR: |
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Bioanalytical scientists; laboratory, outsourcing, and project managers and directors.
This webinar series invites you to find out more about our innovative approaches and specialized techniques to bioanalytical studies to help you meet your project objectives.
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Brigitte Pellerin, Senior Bioanalytical Project Manager, PharmaNet/i3 Brigitte Pellerin received her B.Sc. in Biology, specializing in Microbiology, from the Université de
Sherbrooke, Québec in 2010. She has over fifteen years of experience in method development and
bioanalysis for small and large molecules, six years of which were spent in various managerial roles.
Brigitte rececently presented on Dried Blood Spot techniques at the Canadian Chemistry Conference
in Montreal and has more than 20 posters and scientific articles published at well-known scientific
conferences such as AAPS.
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| OUR XTALKS PARTNER FOR THIS EVENT: |
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PharmaNet/i3, the inVentiv Health clinical segment, is recognized as a leading provider of global product development services to pharmaceutical, biotechnology, generic drug, and medical device companies, offering therapeutically specialized capabilities for Phase I-IV product development, bioanalytical services, and staffing from a single clinical professional to an entire functional team. For intelligent solutions needed to accelerate high quality product development programs of all sizes around the world, PharmaNet/i3 works for you. |
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