Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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SEARCH JOBSIn recent years the global regulatory requirements have continued to evolve in many areas, with new interests in a particular area of focus – the Unique Device Identification (UDI). Whilst at a strategic level the global regulators are aligned in recognizing the need to enhance the traceability of supply of medical devices to and through the global markets, the operational reality has seen the beginnings of some level of divergence across countries.
Whilst regulations often stipulate UDI as a requirement, the data submissions around UDI requirements vary from country to country. The implementation of such UDI regulations can vary with country specific requirements, data structure definitions and other political & economic factors creating additional commercial considerations that begin to mandate what type of UDI solution/ label is required.
In response to all this complexity the instant reaction is "we need a UDI solution" but what exactly is the type of solution that is needed and how should UDI requirements above those stipulated by country health authority regulators be handled?
This webinar is designed to walk you through:
Michael has around 20 years of knowledge and experience leading localised and global teams in Regulatory Affairs and Quality Assurance and has worked within the Medical and Surgical, Orthopaedic, In Vitro Diagnostic, Diagnostic Imaging, Dental and Urology sectors.
As Senior Director of Product and Strategy within the Technology Solutions business of IQVIA, Michael King is responsible ensuring that the Medical Device solutions have the necessary functionality to support the increasingly complex and diverse global regulations. He is particularly focused on optimizing business workflows through intelligence driven simplification and automation within and across the Safety, Regulatory and Quality functions.
With close to a decade of Technology experience in the Healthcare Platform and Medical Device Industry, Anusha is part of the RIM Smart Product Management team at IQVIA. She drives the mapping of business needs to technical requirements and leads business critical engagements in defining RIM Smart Solutions for MedTech. Prior to IQVIA, she worked as a Regulatory and Quality Engineer at Philips Healthcare and before that spearheaded global product launches at two startups - Consure Medical and Sohum Innovation Lab. Anusha holds a master’s in Electrical Engineering from National University of Singapore with rigorous hands-on experience in the medical device and technology development process from the Stanford-Singapore Biodesign program.
Jason Berning has more than 10 years of experience in Regulatory Technologies in various roles that include: consulting, product management, and sales. As an Associate Dir. of Business Development at IQVIA, Jason focuses on bringing transformational Regulatory Technology and Consulting solutions to his customers. He has worked with a wide variety of pharma companies of various sizes and is passionately optimistic about the digitalization of regulatory affairs.
Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.
Automate and standardize your regulatory management, from correspondence and commitments to registration and tracking.
IQVIA RIM Smart. Intelligence, automation and integration.
