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.

Mitch is presently employed at Sciformix as a Principal in the Global Consultancy Services, Safety and Risk Management. Mitch spent 20 years in the pharmaceutical industry, mostly in pharmacovigilance (PV), but has experience in Medical Affairs and International Development. Most of Mitch’s career in the industry was at Pfizer, but he also worked at Johnson and Johnson and Alexion Pharmaceuticals. Mitch held positions of Vice President, Global Safety and Risk Management for Pfizer, Vice President of PV Analytics and Insight at Johnson & Johnson, and finally as Vice President of PV at Alexion Pharmaceuticals. Mitch is also a practicing psychiatrist.

Meghan Mendoza is a Senior Manager of Global Regulatory at Amgen. She serves as the North American Publishing Lead with specific responsibility for the United States and Canada. Meghan has 11 years’ experience working in the biotechnology industry. Prior to leading a Publishing Organization, she served as one of the US Regulatory Information Management Leads with specific responsibility for cross functional interactions and mergers and acquisitions. She’s held various positions throughout Regulatory and Safety. Meghan holds a Masters in Business Administration and has earned her RAC credential from Regulatory Affairs Professional Society (RAPS).

Sonya DaCosta is a Regulatory Affairs Manager of Labeling for the Canadian and US markets at Apotex Inc. She oversees generic labeling of submissions and commercialization of labels for New Products, Marketed Products and Private Label Consumer Products. Sonya has over 15 years of experience in Regulatory Affairs at Apotex and works closely with the RA Affiliates, Pharmacovigilance, Medical Affairs, Quality and Marketing in her organization to ensure labeling is safe, effective and clear to health care professionals and patients.