Scott Willoughby Email & Phone Number

I am a licensed attorney and a registered pharmacist and have spent over 25 years in the healthcare industry, 15 years as in house counsel including time as General Counsel of Rugby Labs and Otsuka America Pharmaceuticals. My practice was focused on FDA related issues,(advertising and promotional activities and drug safety), managing internal investigations and litigation. I joined the Pharmaceutical Research and Manufacturers of America (PhRMA) as Associate General Counsel. While at PhRMA, one of my primary responsibilities was coordinating the efforts of the member companies to draft the first PhRMA Code of Interactions with Healthcare Professionals. Since leaving PhRMA, I provided consulting expertise to many pharmaceutical and medical device companies for compliance with the PhRMA code on Interactions with Healthcare Professionals, the AdvaMed Code and related laws and regulations. Areas where I have provided consulting expertise include sales and marketing compliance, medical science liaisons activities, educational grants, selection process for investigators for clinical trials and grants for investigator sponsored trials. I recently started the consulting group of Scott Willoughby Assoc which provides expert consulting advice in a number of key areas to pharmaceutical and medical device companies. Those areas include: Sales and Marketing compliance assessments Speaker program process review, audit and monitoring Advisory board process review, audit and monitoring Review of third party vendor compliance with adverse event reporting requirements MSL activity assessments Clinical trial site selection process Educational grant policy review and modification IST grant selection process review and modification Independent review of clinical trial processes registers and registries Serving as the legal representative on promotional review committee Conducting independent investigations of hotline and other compliance complaintsSpecialties: Compliance consulting, SOP and policy drafting,conducting compliance related investigations, promotional material review (DDMAC), auditing and monitoring of compliance related matters,

Listed skills include Fda, Pharmaceutical Industry, Clinical Trials, Medical Devices, and 17 others.