The MedTech Market Access series kicks off with the most important pain point: change management. We will review, identify and address how best to assess, track and remediate changes across the Safety, Regulatory & Quality (SRQ) processes, and systems in differing global markets.
Change management systems are complex and have challenging design considerations. The process has multiple levers dynamically moving and interacting across the SRQ systems for the same change triggers. A rugged system that allows smooth-bidirectional interactions across SRQ systems along with intelligent workflows is required. Change triggers complex system interactions at multiple folds including product lines, multiple authorities and countries, internal processes and finally design requirements. Designing and aligning such a complex system requirement is no small challenge…
As a participant in this webinar, you will build a better understanding of:
- The key factors and multidimensional considerations in handling global changes
- Design considerations and challenges affecting change assessment, tracking and implementation
- Need for integrations and dynamic workflows across Safety, Quality and Regulatory systems to simplify and process changes effectively
- Building predictive and adaptive intelligence to be ready for future global changes
Utilize the experience gained and lessons learned by global trends in handling changes to kickstart your journey towards simplifying your Change Management across your SRQ systems, ensuring ease of implementation, global compliance, and preparedness for future targeted changes.
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.
As Senior Director of Product and Strategy within the Technology Solutions business of IQVIA, Michael King is responsible for ensuring that the Medical Device solutions have the necessary functionality to support the increasingly complex and diverse global regulations. He is particularly focused on optimising business workflows through intelligence driven simplification and automation within and across the Safety, Regulatory and Quality functions.
Michael has over 15 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. Before joining IQVIA Michael was the Vice President of International Regulatory Affairs for a Dental Technology organisation and had oversight of the International Product Registration, Adverse Event Reporting and country-based Quality Management Systems.
Michael holds a degree in Physics from Oxford University and briefly worked for a consulting firm in the telecommunications industry prior to beginning his career in the Medical Industry.
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.