Nina Stuccio has over 14 years of experience in the biopharmaceutical industry and is currently Clinical Safety & Risk Management Oncology Therapeutic Area Lead at Merck. A nephrologist, with experience as a clinical trial investigator, she joined the biopharmaceutical industry in 2002 as a Medical Safety Reviewer at Johnson & Johnson. During her 11 years at Amgen, she provided medical safety support for marketed and late development products and led the successful implementation of a new global safety database. She was then Head of Quality Management for Global Regulatory Affairs and Safety at Amgen before joining Merck in 2014 as the Global Head of Medical Safety Review and Clinical Trial Safety Reporting.

Worked in Pharmacovigilance for over 17 years, initially at GSK in the UK, followed by nine years at Amgen in the US including roles as Head of Safety Operations and Head of Regulatory Operations prior to joining Sciformix in 2015. Managed significant global changes in safety processes to improve overall business efficiency including the development of an electronic interface for serious adverse event collection in clinical trials and the implementation of a new safety system. Experienced in developing flexible business models while ensuring compliance and quality delivery.

Aileen Guinto is a pharmacovigilance/medical affairs health professional with over 14 years of diversified experience in the pharmaceutical industry. She is currently Associate Director, Drug Safety at Endo Pharmaceuticals/ PAR Pharmaceutical, Inc. where she oversees third party vendor for PV/drug safety and call center. She is also a medical reviewer and subject matter expert for drug safety and medical information issues on Par products. She has worked for leading pharmaceutical companies like Pfizer, Schering-Plough Corporation, Mayne Pharma and JHP Pharmaceuticals. Aileen is a certified BS Physician Assistant from Touro College and an NYU Alumni Scholar.

Dr. Hoeffner is a physician with trained in basic pharmacological research at the Mayo Clinic followed by clinical training as Anesthesiologist at the University Hospital in Munich, Germany. In January 2017 Dr. Hoeffner joined Glenmark Pharmaceuticals as EU QPPV. Previously she took on increasing responsibilities in Drug Safety. She’s presented in national and international meetings, including Pharmacovigilance meetings in China & the DIA meeting in India with a special interest in strengthening the collaboration between the central site & the local affiliates, increasingly shifting the focus towards a global system in order to gain a common understanding on how Pharmacovigilance should be implemented in a harmonized compliant manner.