Emma Ramnarine, Anders Vinther, Anne Greene, and Kevin O'Donnell

Emma Ramnarine
Sr. Director, Global Head External Development Collaborations, Genentech/Roche

Emma has over 19+ years of global experience in the pharmaceutical, biotechnology and medical device industries in Analytical Science & Technology, Risk Management, Quality Control and Quality Management Systems. She currently manages the external network for the development, manufacturing, and clinical collaborations for Roche’s Biologics and Small Molecules development portfolio. She provided strategic direction and leadership for product analytical control systems lifecycle management, technology innovation and technology transfers. She is also a worldwide-recognized expert on establishing Quality Risk Management (QRM) programs, including providing QRM training to regulatory authorities and at industry forums. Emma is currently on the PDA Board of Directors, and also co-leads PDA’s Post Approval Change Task Force.

She has served on PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB), and led several PDA Task Forces and Technical Reports (TR) including a series of TRs on “Implementation of Quality Risk Management” and “Risk Based Approach for Prevention and Management of Drug Shortages”. She represented PDA on the European Drug Shortages Team formed under EMA’s direction. Emma holds an M.S. in Pharmaceutical Sciences from University of Connecticut, an M.S. in Medicinal & Pharmaceutical Chemistry, and a B.S. in Pharmacy, both from University of Indore, India. She is currently pursuing her PhD in Pharmaceutical Sciences from Technological University Dublin. Her research is on the topic of solving the continual improvement and innovation challenge in the pharmaceutical industry and this is what we will speak with her about today.

Anders Vinther, Ph.D.
VP, Site Head, Intarcia Therapeutics

Anders is currently Site Head and VP of Global Quality at Intarcia Therapeutics Inc. Prior to that Anders has held various senior Quality leadership positions at Sanofi Pasteur, Roche, Genentech, CMC Biologics and Novo Nordisk. Anders is a quality industry thought leader with experience from successful start-ups to quality, business and culture turnarounds. He previously was Chairman of the Board of Directors for PDA, and is actively engaged in the dialog on reduction of drug shortages and enhanced innovation in the pharmaceutical industry.

Anne Greene, Ph.D.
Professor, TU Dublin

Anne leads the Pharmaceutical Regulatory Science Team (PRST) in TU Dublin, where she is also a senior lecturer and director of the several MSc. and BSc. Pharmaceutical Programmes, including the TU Dublin MSc in Pharmaceutical Validation Technology.  She has supervised several students to PhD awards in areas of Quality Risk Management, Knowledge Management, Operational Excellence and PAT. Prior to embarking on an academic career, Anne worked at a senior level for several years in the pharmaceutical sector in Validation and Technical Management roles. Anne has a PhD in Synthetic Organic Chemistry from University College Dublin, and is currently a member of committee of the Irish Chapter of PDA. Anne is also on the Board of Directors of Regulatory Science Ireland (RSI) and is chair of the Corporate Development Committee.

Kevin O’Donnell, Ph.D.
Market Compliance Manager, Health Products Regulatory Authority (HPRA)

Kevin is Market Compliance Manager at the Health Products Regulatory Authority (HPRA, formerly known as the IMB).  He is responsible for a number of compliance-related programs at HPRA, including the quality defect and recall program and HPRA’s sampling and analysis activities. Kevin is also a senior GMP Inspector at the HPRA.  He obtained his PhD in the field of Quality Risk Management from the Dublin Institute of Technology in 2008.  He is currently chair of the PIC/S Expert Circle on QRM.



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