Medical Device Regulatory Intelligence Virtual Series

Medical Device Regulatory Intelligence Virtual Series - June 20, 21, 24, and 25, 2024

Digital Transformation & the Everchanging Regulatory Landscape

This Series explores the significant changes across the regulatory landscape and how digital transformation is impacting Regulatory Intelligence and Medical Device Compliance throughout your products' lifecycles.

Presented by MedTech Intelligence, the Medical Device Regulatory Intelligence Virtual Series offers four 3-hour virtual learning sessions designed to help regulatory leaders and their organizations recognize and understand key trends, challenges, and solutions impacting the strategy, execution, and monitoring of Medical Device regulatory process and product compliance. Sessions address a breadth of content – from the ever-changing global landscape of Global MDR requirements to the latest guidance for integrating transformative technologies and data into your design, manufacturing, and quality systems.

Speakers will share strategies and practices to help you navigate appropriate regulatory pathways with greater efficiency throughout your products' lifecycles. Informative sessions and panels are structured to provide actionable takeaways for enabling conformity, profitability, and sustainability among regulatory approval and compliance processes supporting product management.

Join us online beginning June 20 at 10 AM ET (US) for the Medical Device Regulatory Intelligence Virtual Series to hear new ideas, industry trend data, the latest productivity tools & software.

Where/When

The Virtual Series is being hosted online by MedTech Intelligence starting June 20, 2024.

Day 1: June 20, Noon-1:00pm - Global Regulatory Harmony - Reality or Impossibility?

Day 2: June 21, Noon-1:00pm - Total Product Lifecycle Risk Management

Day 3: June 24, Noon-1:00pm - Digital Regulatory Management

Day 4: June 25, Noon-1:00pm - SaMD/SiMD - Medical Device Software Development and Maintenance


Who Should Attend:

The Summit is designed to instill critical insights for strategic planning among managers and executive leadership, plus provide operational learning for regulatory/compliance teams and cross-functional product teams responsible for compliant product management and support.

Functional Roles & Departments:

Mid and senior managers involved with Regulatory Affairs (RA) and Quality Assurance (QA), Quality Control (QC), Validation, Market Access, R&D Design, Product Engineering, Manufacturing Engineering, Product Management, Regulatory Systems Management, Compliance Systems Management, Quality Systems Management, Project Management.

Registration Options

Registration prices start at $95/Day | Team Discounts Available



REGISTRATION OPTIONS

Individual Virtual Registration - Attend for a single day or register for the full series as an Individual Virtual Attendance*. This registration option provides access by a single virtual participant. Session recordings for programs will be available for respective post-conference on demand viewing and are included with your registration.

  • Single Day Registration - $95/day

  • Full Series Registration - $325

Enterprise (Full Team) Virtual Attendance: Access ALL sessions virtually with an Enterprise Virtual Only Attendance**. This is a Corporate Registration providing unlimited access for your organization using a single company email domain (an individual company email address for each participant is required in advance for access security)Session recordings from the program will be available for post-conference on demand viewing and are included for with registration.

  • Unlimited team/associate registration - $695

*Virtual Attendance is via a webinar broadcast of the conference. Attendees can ask the speakers questions in real time. An archive recording of the program is provided for post-conference on demand viewing.

**One registration price is for as many attendees from your organization as you like.

A Certificate of Participation is provided to all on-site and virtual attendees for your ongoing CEUs.


Agenda
Thursday, June 20
10:00 AM - 1:00 PM
10:00 AM - 1:00 PM
Global Regulatory Harmony - Reality or Impossibility?
10:05 AM - 10:45 AM
10:05 AM - 10:45 AM
Leeanne Baker, Managing Director & Senior QA/RA Consultant IMed Consultancy
10:45 AM - 11:25 AM
10:45 AM - 11:25 AM
11:25 AM - 12:05 PM
11:25 AM - 12:05 PM
12:05 PM - 12:45 PM
12:05 PM - 12:45 PM
Leeanne Baker Managing Director - Managing Director & Senior QA/RA Consultant IMed Consultancy
12:45 PM - 12:50 PM
12:45 PM - 12:50 PM
Friday, June 21
10:00 AM - 1:00 PM
10:00 AM - 1:00 PM
QMSR & Total Product Lifecycle Risk Management
10:05 AM - 10:45 AM
10:05 AM - 10:45 AM
Michael Heyl, Partner, Global Regulatory Hogan Lovells
10:45 AM - 11:25 AM
10:45 AM - 11:25 AM
Kimberly Trautman, Managing Director Trautman International Services
11:25 AM - 12:05 PM
12:05 PM - 12:45 PM
12:05 PM - 12:45 PM
Joy Greidanus, Director – Medical Device SME Dr Pratibha Mishra, Manager/Sr. SME, Medical Device Services Celegence
12:45 PM - 12:50 PM
12:45 PM - 12:50 PM
Monday, June 24
10:00 AM - 1:00 PM
10:00 AM - 1:00 PM
Digital Regulatory Management
10:05 AM - 10:45 AM
10:05 AM - 10:45 AM
Soumya Mahapatra, Founder and CEO Dr. Dhriti Roy, Vice President of Regulatory Transformation Essenvia
10:45 AM - 11:25 AM
10:45 AM - 11:25 AM
Rene Zoelfl, Global Industry Advisor Life Science PTC
11:25 AM - 12:05 PM
11:25 AM - 12:05 PM
Dr. Amelia Hufford, SVP, Clinical & Regulatory Science Operations 3Aware
12:05 PM - 12:45 PM
12:05 PM - 12:45 PM
Austin C. Speier, Chief Strategy Officer Click Therapeutics
12:45 PM - 12:50 PM
12:45 PM - 12:50 PM
Tuesday, June 25
10:00 AM - 1:00 PM
10:00 AM - 1:00 PM
SaMD/SiMD - Medical Device Software Development and Maintenance
10:05 AM - 10:45 AM
10:05 AM - 10:45 AM
10:45 AM - 11:25 AM
10:45 AM - 11:25 AM
Shannon Lantzy, President Shannon Lantzy LLC
11:25 AM - 12:05 PM
11:25 AM - 12:05 PM
12:05 PM - 12:45 PM
12:05 PM - 12:45 PM
12:45 PM - 12:50 PM
12:45 PM - 12:50 PM
Speakers
Co-founder and SVP, Clinical and Regulatory Science Operations
3Aware
Chief Strategy Officer
Click Therapeutics
President
Shannon Lantzy LLC
Managing Director
Trautman International Services
Managing Director - Senior QA/RA Consultant
IMed
President
MEDIcept
Global Industry Advisor Life Science
PTC
Director – Medical Device SME
Celegence
Founder and CEO
Essenvia
President
Pacific Bridge Medical
Manager/Sr. SME, Medical Device Services
Celegence
Vice President of Regulatory Transformation
Essenvia
Partner, Global Regulatory
Hogan Lovells

No records found.

Sponsors
Summit Sponsor

FREQUENTLY ASKED QUESTIONS

Where is the event taking place:

The event will take place online

What are the registration prices:

  • Enterprise Registration (UNLIMITED Team Access) - $695
  • Individual Registration - $325
  • Daily Session Registration - $95/Day

How can my company become a sponsor of the event?

How do I log in to the event?

  • You will receive an email with a link to GoToWebinar with instructions how to log into the live event. Please note that this will be a live event, and you will be able to see, listen and ask questions for the presenters in REAL time.

Can I ask questions of the speakers?

  • Yes! You will be able to type your questions into a chat dialog box and the moderator will read it out loud to the speakers.

What happens if I miss the event:

  • There are no refunds or cancellations within 7 business days of the starting date of the event for virtual or on-site participants.

Cancellation and Refund Policy:

  • All cancellations must be made via email. Should you not be able to attend the conference, you may have someone else from your organization take your place or use your registration fee as credit towards a future MedTech event. If these options are not possible, you can receive a refund of the registration fee less a 20% processing fee up until 7 business days prior to the conference. There are no refunds for cancellations within the 7 business day period prior to the conference or for "no-shows" to the conference. This cancellation applies for both on-site and virtual registrations.