Webcast
Design For Registration: Principles Of A Global Approach
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September 28, 2022

Kalender
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10:00am - 11:00am

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Imagine...a regulatory bot that could answer your regulatory questions, powered by a level of automated and connected intelligence which could identify errors with submissions. A bot that could learn through time the patterns of required data in each country submission and revise content based on trends from the predicates of previous similar submissions! So maybe we are dreaming a little, yet these hopes for how technology can be in the future drive us to utilize the tools we have today in the present.

The successful future of global product launches is not just captured by the speed of registration alone, but also includes factors such as the predictability of process cycles, delivering consistent right first time submissions, designing for parallel country submissions and executing smarter global change management programs. This requires building market intelligence, assimilating information that captures global variations and requirements per product and country types, and transparent communication with conscious decision making across a company's global teams.

This webinar is designed to help you identify and build a better understanding of:

  • What are some go to market challenges faced by organizations today
  • How areas in MedTech global product launches would benefit from Regulatory Intelligence systems
  • Why integration of systems and connectivity between PLM-QMS-RIMs can support regulatory processes
  • The benefits of automation opportunities in data-process and workflows across the product lifecycle
Speakers

Michael King

Senior Director, Product & Strategy, IQVIA

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.

Anusha Gangadhara

Business System Analyst, IQVIA

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

Associate Business Development Director, Regulatory Technology Solutions, IQVIA

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.

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