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Dr. Albert Edwards

Healthcare

Edwards was employed for 42 years in the pharmaceutical and life sciences arenas.

From 1990 to 2010, he held Regulatory Affairs positions of increasing responsibility at TAP/Takeda Global Research & Development Center, Lake Forest, Illinois.  Between 1996 and 2010, he led the implementation and oversight of the esubmission paradigm. This resulted in TAP’s dominance in eCTDs during 2006-08, with TAP submitting more than half of all eCTDs sent to FDA.

Prior to his tenure at TAP, Edwards gained additional career experience as a Medical Review Officer at FDA, scientist at NIH, and a teacher and researcher in several university health-science settings.

During his time at TAP, Edwards was active in the Regulatory Affairs Professionals Society [RAPS], serving as President-Elect in 2003, President in 2004, and Chairman of the Board in 2005.

Since retirement, he has organized a consulting business for health care product companies and litigation professionals [FDAexpert@gmail.com]. More recently, Edwards has developed eSubmissions University, www.esubmissionsuniversity.com.  The new organization is focused on teaching companies and individuals of limited resources how to make successful electronic submissions to the FDA.

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