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MedTech Market Access Trends In 2022 is a specially curated series that will deliver RIM SMART MedTech insights to the industry. The series will discuss important and unmet market needs around product lifecycle and global launches in MedTech and will be an opportunity to enhance audience understanding by leveraging IQVIA's decades of RIM technology experience. Each webinar will be a window into the current scoping of key RIM features, intelligent workflows and smart automations designed to change the global product launch landscape in MedTech.


Now Available - On Demand

Embracing Change And Dealing With It

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.


Speakers

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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.

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Michael King

Senior Director, Product & Strategy, IQVIA


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.

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Moderated By:

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.

SEPTEMBER 28, 10:00AM-11:00AM US-ET

Design For Registration: Principles Of A Global Approach

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

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Michael King

Senior Director, Product & Strategy, IQVIA


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.

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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.

alt text

Moderated By:

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.

NOVEMBER 10, 10:00AM-11:00AM US-ET

UDI Requirements – The Fear Of The Unknown

In 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:

  • Demystifying global UDI requirements, definitions and challenges across important markets
  • Considerations and complexities in designing systems for UDI
  • UDI workflows across Safety, Regulatory and Quality (SRQ) systems
  • Intelligent workflows for UDI and Labeling automation

Speakers

alt text

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.

alt text

Michael King

Senior Director, Product & Strategy, IQVIA


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.

alt text

Moderated By:

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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