Date and time: 29 June 2021 15:00 - 16:00 BST
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Agenda
Digitalization is an overused term describing the removal of paper-based processes within your existing business. However, true digital transformation is about the ability to do business in a fundamentally new, digital way.
Global regulatory agencies are adopting more digital solutions with the goal of efficiently processing more information. This includes solutions such as the EU EUDAMED, FDA eSTAR 510(k) program, the Chinese eRPS and more. The ultimate goal is to process a higher volume of submissions, while improving data quality and consistency. This reduces agency costs, eliminates manual, time-consuming administrative activities, and decreases cycle time for high-volume, complex regulatory submissions.
With government agencies increasingly adopting digital solutions, many MedTech companies still struggle with outdated, manual, word processing solutions that are administratively burdensome. Time-to-market is a critical competitive advantage, and so is the ability to keep up with an ever-evolving regulatory landscape. For MedTech companies, digital transformation is key to both outcomes.
In this presentation, we will discuss:
• A few ways agencies have started to adopt a digital approach to regulatory reviews (premarket and postmarket)
• A deep dive into current challenges within MedTech companies
• Steps you can take to start to prepare
• What digital transformation looks like within a MedTech company
This Webinar is Sponsored by:
Disclaimer: Whilst TOPRA is hosting this webinar for Rimsys, this is not an endorsement of Rimsys, its affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.
Learning objectives
By attending the webinar you will learn to:
- Take advantage of a new opportunities for electronic regulatory submissions around the world
- Structure and organize data for electronic submissions
- Identify digital transformation opportunities to streamline regulatory processes and accelerate time to market.
Suitable for
- Regulatory affairs practitioners who are responsible for product submissions
- Regulatory affairs leaders who are looking to improve productivity across their teams
- Any regulatory professional who want to learn more about how the global market adoption of digital solutions for regulatory affairs
As well as people with job titles including:
- VP, Regulatory Affairs (MedTech)
- Director, Regulatory Affairs (MedTech)
- Regulatory Affairs Manager (MedTech)
- Regulatory Affairs Associate or Coordinator (MedTech)
- Regulatory Affairs Project Manager, Engineer, or IT Manager (MedTech)
Speaker
James Gianoutsos
Founder & President
Rimsys Regulatory Management Software
James Gianoutsos is a quality assurance and regulatory affairs professional who has a diverse background in the medical device, pharmaceutical and biologics industries. James’ professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and post-market surveillance of drug products and class I, II, and III devices. It also includes products in a variety of clinical applications including infant jaundice management, neonatal respiratory care, infant incubation, sleep therapy, management of respiratory insufficiency, surgical adhesive for internal use, surgical sealant for prevention of gastrointestinal leaks, and bone healing accelerants.
James has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD, CMDCAS requirements and standards and has helped develop and submit multiple regulatory filings including Premarket Approvals (PMA), 510(k)s, Design Dossiers, Technical Files and INDs. James holds a Bachelor of Science in operations management as well as a Master of Business Administration (MBA) with a concentration in operations management and strategy from the University of Pittsburgh – Katz Graduate School of Business.
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Pricing
- Members: free
- Non-members: free
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