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Bells Corners, Canada

Savoie N.,Algorithme Pharma Inc. | Garofolo F.,Algorithme Pharma Inc. | Van Amsterdam P.,Solvay Group | Booth B.P.,U.S. Food and Drug Administration | And 10 more authors.
Bioanalysis | Year: 2010

The 3rd Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis was organized by the Calibration and Validation Group as a 1.5-day full immersion workshop for contract research organizations, pharmaceutical companies and regulatory agencies to discuss several 'hot topics concerning bioanalytical issues and regulatory challenges. A consensus was reached among panelists and attendees on many points regarding method validation of small molecules. © 2010 Future Science Ltd. Source


Savoie N.,Algorithme Pharma Inc. | Garofolo F.,Algorithme Pharma Inc. | Van Amsterdam P.,Abbott Laboratories | Bansal S.,Hoffmann-La Roche | And 18 more authors.
Bioanalysis | Year: 2010

The 4th Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis, a 2-day full immersion workshop, was organized by the Calibration and Validation Group. Contract research organizations, pharmaceutical companies and regulatory agencies came together to discuss several 'hot topics concerning bioanalytical issues and regulatory challenges and to reach a consensus among panelists and attendees on many points regarding method validation of small and large molecules. © 2010 Future Science Ltd. Source


Garofolo F.,Algorithme Pharma Inc. | Rocci Jr. M.L.,ICON Development Solutions | Dumont I.,Algorithme Pharma Inc. | Martinez S.,Algorithme Pharma Inc. | And 27 more authors.
Bioanalysis | Year: 2011

The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics. © 2011 Future Science Ltd. Source


Desilva B.,Bristol Myers Squibb | Garofolo F.,Algorithme Pharma Inc. | Rocci M.,ICON Development Solutions | Martinez S.,Algorithme Pharma Inc. | And 36 more authors.
Bioanalysis | Year: 2012

Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, focused, highly interactive and informative workshop aiming for high-quality, improved regulatory compliance and scientific excellence. Numerous 'hot topics in bioanalysis of both small and large molecules were shared and discussed, leading to consensus and recommendations among panelists and attendees representing the bioanalytical community. The major outcome of this years workshop was the noticeable alignment of multiple bioanalytical guidance/guidelines from different regulatory agencies. This represents a concrete step forward in the global harmonization of bioanalytical activities. The present 2012 White Paper acts as a practical and useful reference document that provides key information and solutions on several topics and issues in the constantly evolving world of bioanalysis. © 2012 Future Science Ltd. Source


Stevenson L.,Biogen Idec | Garofolo F.,Algorithme Pharma Inc. | Desilva B.,Bristol Myers Squibb | Dumont I.,Algorithme Pharma Inc. | And 57 more authors.
Bioanalysis | Year: 2013

The 2013 7th Workshop on Recent Issues in Bioanalysis was held in Long Beach, California, USA, where close to 500 professionals from pharmaceutical and biopharmaceutical companies, CROs and regulatory agencies convened to discuss current topics of interest in bioanalysis. These 'hot' topics, which covered both small and large molecules, were the starting point for fruitful exchanges of knowledge, and sharing of ideas among speakers, panelists and attendees. The discussions led to specific recommendations pertinent to bioanalytical science. Such as the previous editions, this 2013 White Paper addresses important bioanalytical issues and provides practical answers to the topics presented, discussed and agreed upon by the global bioanalytical community attending the 7th Workshop on Recent Issues in Bioanalysis. © 2013 Future Science Ltd. Source

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