Colleen Walsh | Vice President, Global Safety Operations
Alnylam Pharmaceuticals
Colleen Walsh is a veteran biotech professional with over two decades of experience working in multiple areas of the industry, with a primary focus in pharmacovigilance and quality. She has worked in senior management roles in small, mid, and large sized organizations and has expertise in all areas of PV including case management, compliance and quality, regulatory/expedited reporting, aggregate report writing, risk management plans/REMS, clinical trial support (ICF, IB, protocol management), patient registries, and inspection readiness. She currently leads the Global Safety Operations and Systems team at Alnylam.
Appearances:
Day 2 - World Drug Safety Congress Americas @ 12:35
Panel: The Outsourcing Partnership Playbook: Bridging Expectations, Boosting Productivity, and Achieving Mutual Success
Outsourcing safety activities offers several strategic and operational benefits to sponsors. It spans from Global footprint to cost efficiency encompassing access to specialized knowledge, and scalability, among others. However, there are several challenges that need to be taken into consideration. For example, oversight, differences in time zones, quality issues and non-compliance, vendor dependency, costs, and others. Recognizing those factors is the recipe for a successful outsourcing partnership which will be explored in this panel discussion.
Sponsored by ThermoFisher Scientific.
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Karen Duncan
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