PharmaLex Adds Pharmacovigilance To Service Portfolio in US
As of 17th January, 2017, the PharmaLex Group, a leading specialist provider of Development Consulting & Scientific Affairs, Regulatory Affairs and Pharmacovigilance, has enhanced its service portfolio in the US with the addition of a key specialist in the field of Pharmacovigilance.
Wenda Brennan joins PharmaLex as Head of Pharmacovigilance Services, North America. Wenda has over 30 years of pharmaceutical experience, the past 18 years concentrated in Safety and Risk Management. Her experience includes implementing and managing safety departments to support all safety activities for studies, registries and spontaneous reporting programs. She has overseen the safety case processing for thousands of products and has provided consulting services to new companies developing safety departments in establishing processes and SOPs. Additionally, Wenda has directed several product recall operations for bariatric medicine, pain management and diabetes products.
Prior to joining PharmaLex, Wenda’s safety experience included launching the Phase IV Pharmacovigilance division of Covance, creating and overseeing a global service provider Pharmacovigilance department and providing PV leadership to C3iHC during integration of Sentrx Safety. In conjunction with the FDA, Wenda designed and implemented the iPLEDGE Risk Management program and has conducted project management and safety management activities for Risk Management Programs in the areas of dermatology, psychology, CNS, device and gastroenterology. In her experience she has overseen complex safety reporting requirements for 11 FDA mandated risk management programs.
Wenda received her degree in Pharmacy from the University of the Sciences in Philadelphia, Philadelphia College of Pharmacy and has held adjunct faculty appointments at the University of Delaware and University of the Sciences in Philadelphia.
In her current role at PharmaLex, Wenda is responsible for the development and growth of US safety services.
“The addition of Pharmacovigilance to the US service portfolio is an important development for us” explained Dr. Thomas Dobmeyer, CEO PharmaLex. “Wenda’s vast experience and expertise will allow us to expand our existing offer for our US clients, enabling us to provide a complete portfolio for regulatory and safety services during a product lifecyle from the initial development through to drug safety monitoring” added Dr. Tilo Netzer, CEO PharmaLex.
This article has been republished from materials provided by PharmaLex. Note: material may have been edited for length and content. For further information, please contact the cited source.
Easily Automate PK Assays for Human IgG Drugs in Preclinical SpeciesNews
At AAPS NBC event, Lumigen produced a poster summarizing the use of their pipetting robot, Andrew which can measure IgG drug concentration in a pre-clinical setting.READ MORE
Could This Be a "Silver Bullet" for Preventing and Treating Colon Cancer?News
A team of scientists targeted the gene CtBP with a drug known as HIPP (2-hydroxy-imino phenylpyruvic acid) and were able to reduce the development of pre-cancerous polyps by half.READ MORE
Ingestible Drug-Delivery Materials May Improve Patient Treatment ComplianceNews
Hydrogel-based capsules could expand and reside in the GI tract for days, slowly releasing medication.READ MORE
Comments | 0 ADD COMMENT
8th International Symposium on Recent Advances in Food Analysis (RAFA 2017)
Nov 07 - Nov 10, 2017
6th Edition of International Conference on Pharmacognosy and Medicinal Plants
Apr 16 - Apr 17, 2018
International Conference and Exhibition on Nanomedicine and Nanotechnology
Nov 23 - Nov 24, 2017