Lisa serves as Vice President of Regulatory Affairs for Ergomed plc, covering both Ergomed CRO and PrimeVigilance.
Lisa brings 20 years of multidisciplinary experience within the pharmaceutical industry in regulatory affairs, pharmacovigilance, quality assurance and auditing. Her regulatory expertise encompasses CTA, MAA and post-marketing activities and spans across a wide range of therapeutic indications.
Lisa has a successful track record of senior project oversight, supporting regulatory strategies and driving operational execution as well as line management and team leadership.
She is a CMC expert with broad knowledge of FDA, EMA, Latin American and Asia Pacific regulations and experience in negotiating with EMA, as well as numerous national agencies and has led National Scientific Advice meetings and CHMP Oral explanation.
Lisa earned her Master’s Degree in Pharmaceutical Chemistry from the University “La Sapienza” of Rome.
