YourEncore Launches Center of Excellence to Help Pharma Companies Ensure Patient Safety and Regulatory Compliance
Industry-Accomplished Pharmacovigilance Experts Available to Help Pharma Companies Manage Safety and Regulatory Compliance Throughout the Product Lifecycle
(firmenpresse) - INDIANAPOLIS, IN -- (Marketwired) -- 10/28/14 -- YourEncore (), a company that helps , and solve complex innovation, compliance and productivity challenges, has launched the Safety Center of Excellence, which provides to help life sciences companies monitor the effects of medical drugs throughout the product lifecycle.
Pharmacovigilance or Product Safety is necessary to ensure patient safety for drug and medical device products from the time of the initial clinical trials through their commercial life span. New sources of safety data from social media, changing regulatory requirements, and resourcing key talent for the ebb and flow of product portfolios have escalated the challenge of protecting patient safety.
"In addition to other challenges, 2014 has been one of the busiest years for pharmaceutical mergers and acquisitions, and this activity has made the monitoring of drug safety especially difficult and chaotic," said Tim Franson, M.D., YourEncore''s Chief Medical Officer. "YourEncore is able to provide experts with decades of experience in pharmacovigilance who are available to rapidly deploy."
YourEncore has been providing pharmacovigilance expertise to life science companies since its founding in 2003.
The Safety Center of Excellence is composed of industry-best experts in all areas of pharmaceutical safety, including:
Serious/Targeted Adverse Event Review
Safety Surveillance & Signal Detection/Evaluation
Safety Issue/External Inquiry Management
Regulatory Safety Reporting
Benefit/Risk Management
Safety Management of Post-Marketing Outreach Programs
Pharmacovigilance Auditing
Working closely with Dr. Franson, the Center of Excellence will further expand the depth and breadth of available expertise, giving clients quicker access to a range of Pharmacovigilance experts for targeted, customized solutions.
The YourEncore Safety Center of Excellence is led by Rick Huddleston, a 40-year veteran of the pharmaceutical industry, who spent more than 33 years at Eli Lilly and Company, where he held leadership roles in both Quality and Pharmacovigilance.
"YourEncore''s professionals include a range of safety specialists, including physicians, clinical scientists, epidemiologists, pharmacists, registered nurses, safety database experts, and Pharmacovigilance quality experts," said Huddleston. "Our experts have worked with all types of pharmaceutical products, including small and large molecules, generics, and over the counter (OTC), as well as medical devices and companion diagnostics."
Indianapolis-based YourEncore, an Inc. 5000 company, helps companies in the , and industries solve complex innovation, compliance and productivity challenges by deploying industry-accomplished experts. , which include MDs, PhDs, executives and practitioners, have on average 25 years of experience and are behind many of the most successful products on the market. In addition to advisory services, the company also offers the resources to act on its recommendations. Founded in 2003, YourEncore today works with 12 of the 15 leading global pharmaceutical companies and four of the six top consumer care companies. For more information, visit and follow us on and .
FOR INFORMATION CONTACT:
Linda Muskin
847.432.7300
Mara Conklin
678.825.2000
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Datum: 28.10.2014 - 05:01 Uhr
Sprache: Deutsch
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