The Digital Transformation of MedTech Regulatory Affairs

1.5
RAC Credits
Virtual Programs Virtual Programs
Thursday, 16 June 2022 (11:00 AM) - Thursday, 16 June 2022 (12:30 PM) Eastern Time (US & Canada)

Global regulatory agencies are adopting more digital solutions with the goal of efficiently processing more information, including solutions such as the EU EUDAMED, FDA eSTAR 510(k) program, and Chinese eRPS. The ultimate goal is to process a higher volume of submissions, while improving data quality and consistency in order to reduce agency costs, eliminate time-consuming administrative activities, and decrease 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With government agencies increasingly adopting digital solutions, many MedTech companies still struggle with outdated, manual, word processing solutions that are administratively burdensome.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 RA teams, digital transformation is key to both outcomes.

Learn how organizations can respond to the growing adoption of digital solutions by global regulatory agencies and how to process a higher volume of submissions while improving data quality and consistency.

Registration Fees & Deadlines

2 March 2022 – 16 June 2022: Regular $175 member | $200 nonmember

Learning Objectives 

After this program, participants will:

  • Know how digital transformations within regulatory agencies will impact their regulatory processes (submissions, correspondence, UDI, post-market, etc.)
  • Understand how these pending changes across regulatory agencies and growing regulatory complexity within MedTech present opportunities for digital transformations within their organizations.
  • Be familiar with common challenges to successful digital initiatives within MedTech regulatory teams, and how to address them.

Who Should Attend? 

  • Regulatory affairs leaders and professionals in the medical technology space (medical device, in vitro diagnostic, medical software, and combination products)
  • IT partners, business analysts, and project managers who support or work with regulatory teams in the medical technology space

Agenda

  • Why digital transformation for RA? Why digital transformation for MedTech?
  • Digital adoption trends across global governing bodies
  • 5 key challenges in MedTech RA today
  • Best practices for getting started with digital initiatives
  • 3 examples of successful digital transformation in MedTech

The agenda may vary based on changing requirements.

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Instructors:

James Gianoutsos

James Gianoutsos, Founder & CEO at Rimsys Regulatory Management Software

James Gianoutsos is a quality assurance and regulatory affairs professional with a diverse background in the medical device, pharmaceutical and biologics industries. His professional experience includes the design, premarket approval, clinical trials, manufacturing, distribution and postmarket surveillance of drug products and Class I, II and III devices. He has worked with 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. Gianoutsos has extensive experience in establishing and maintaining quality management systems in accordance with FDA, ISO, cGMP, MDD and 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. He earned an MBA with a concentration in operations management and strategy from the University of Pittsburgh.

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Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance following the workshop.

Questions

Contact the RAPS Solutions Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email raps@raps.org  

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