Medical Device Regulatory Intelligence Summit - June 3-5, 2024

Digital Transformation & the Everchanging Regulatory Landscape

This Summit explores the WHY behind the significant changes across the regulatory landscape and HOW digital transformation impacts Regulatory Intelligence and your medical device compliance throughout the product lifecycle.

Several factors contribute to the transformation underway in regulatory strategy and compliance management. Many are driven by patient (consumer) recognition that responsibility for their health is in their own hands. Advanced Technologies have helped to inspire this Healthcare Consumerism. As a result, the healthcare industry is focused on improved access to care and patient outcomes enhancing episodic care. ESG initiatives are impacting consumers’ care choices. Similar technologies offer process efficiency and effectiveness in regulatory management. Hear more about the WHY behind recent regulatory change…and what might be expected still!

Presented by MedTech Intelligence, the Medical Device Regulatory Intelligence Summit is an intimate and interactive forum 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 and workshops during the 3-day Summit deliver insights addressing a breadth of content – from the ever-changing global landscape of MDR requirements to the latest guidance for integrating transformative technologies and data into your design, manufacturing, and quality systems. Speakers will also share strategies and practices for navigating appropriate regulatory pathways across your respective processes and throughout your product lifecycles. Informative panels, educational workshops and professional networking are structured to provide actionable takeaways for enabling more efficient and sustainable regulatory approval and compliance in support of profitable product management.

Join us in Washington DC on June 3-5 for the Medical Device Regulatory Intelligence Summit. Hear new ideas, see industry trend data, explore the latest tools, software, and technologies, and network with regulatory officials and industry leaders.

Topics addressed include:

  • Recognizing and understanding potential impacts & obstacles of current regulatory trends
  • Risk Management across your device portfolios and product lifecycles
  • New legislation and innovation impacting your regulatory strategy
  • Aligning with current FDA Strategic Priorities
  • Global Regulatory Efficiency
  • Framework and guidance for transformational technologies enabling new regulatory approaches (RWD/RWE, AI/ML, Simulation, Digital Twins)
  • Digital Health Regulatory Fundamentals
  • Tools for increasing diversity in clinical trial populations

Where/When

The Summit is being hosted on June 3-5, 2024 in the conference facilities at the Law Offices of Hogan Lovells located at 555 13th Street NW, Washington, DC.

Day 1: June 3, Noon-5:00pm - Optional Pre-Conference Workshops (FREE with your Summit Registration)

Day 2: June 4, 8:30-5:00pm -  Summit General Sessions (Networking Reception 6:00pm)

Day 3: June 5, 8:30-4:00pm - Summit General Sessions


Be a Presenter

Do you have relevant educational content our attendees can learn from? Submit an abstract, and our Advisory Team will consider it for our agenda.

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.

On-site and Virtual attendance registration options

Registration prices start at $695 | Team Discounts Available


In-person Attendance

Individual Registration: Attending in-person is the best experience to network with peers and speakers. Session recordings from the program will be available for post-conference on demand viewing and are included with your registration.


Enterprise Hybrid (TEAM) Registration: This Corporate Registration allows TWO (2) in-person registrations PLUS unlimited access for virtual attendees from your organization. The in-person option provides you the ability to be present in "the room when it happens" to network with colleagues and vendors. The virtual option provides access to the conference via online access for team members who can not attend in person. This registration also includes access to all archived recordings by your entire team. (individual company email address required to secure virtual access for each participant). Please contact Veronica Allen at vallen@innovativepublishing.net to register your 2nd in-person attendee.


Virtual Attendance

Individual Virtual Registration - Join the Summit sessions virtually with an Individual Virtual Attendance*. This registration option provides access by a single virtual participant. Session recordings from the program will be available for post-conference on demand viewing and are included with your registration.


Enterprise Virtual Attendance: No travel budget but want your team to attend? Access ALL sessions virtually with an Enterprise Virtual Only Attendance**: This is a Corporate Registration that provides you with an Unlimited number of Virtual Participants 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.


*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
Monday, June 3
12:00 PM - 12:45 PM
12:00 PM - 12:45 PM
12:00 PM - 5:00 PM
12:00 PM - 5:00 PM
12:45 PM - 2:45 PM
12:45 PM - 2:45 PM
This workshop educates participants to develop and execute a PMCF plan as part of their post-market surveillance (PMS) obligations to mitigate risks of non-compliance and potential regulatory sanctions.
Precision medicine is the future of healthcare. Companion Diagnostics and Gene and Cell Therapy provide a basis to deliver personalized medicine and are key to new treatments. This session explores the status of companion diagnostics in Asia.
2:45 PM - 3:00 PM
2:45 PM - 3:00 PM
3:00 PM - 5:00 PM
3:00 PM - 5:00 PM
This workshop provides a structured learning process enabling participants to fully understand the nuances of moving from FDA QMSR to ISO 13485 for Medical Device Quality Management and create assessment & implementation plans within their organizations.
Tuesday, June 4
8:00 AM - 8:30 AM
8:00 AM - 8:30 AM
8:30 AM - 8:45 AM
8:30 AM - 8:45 AM
8:45 AM - 9:20 AM
8:45 AM - 9:20 AM
9:20 AM - 9:55 AM
9:20 AM - 9:55 AM
The 2024 State of US MedTech Regulation report unveils critical shifts and advancements in US MedTech - the surge in FDA medical device approvals, post-COVID innovation landscape, digital transformation, AI, and breakthrough device designations.
9:55 AM - 10:30 AM
9:55 AM - 10:30 AM
How does the ‘digital thread’ - a continuous flow of data and information that connects all the stakeholders and activities - help MedTech organizations automate regulatory compliance, and improve quality, and patient outcomes.
10:30 AM - 10:45 AM
10:30 AM - 10:45 AM
10:45 AM - 11:20 AM
10:45 AM - 11:20 AM
While many medical device manufacturers already certified to ISO 13485:2026 may think the new FDA QMSR is "no big deal," there are nuances & influences impacting all manufacturers. The session is a deep dive into these nuances & tangential influences.
11:20 AM - 11:55 AM
11:20 AM - 11:55 AM
New global regulatory requirements have “upped” the game for RMS and QMS processes. How can you prepare and defend you continual evaluation and updating across your Risk Management Files and medical device families?
11:55 AM - 12:30 PM
11:55 AM - 12:30 PM
12:30 PM - 1:30 PM
12:30 PM - 1:30 PM
Systematic Literature Review - technologies enabling streamlined workflow and reducing risk of errors.
1:30 PM - 2:05 PM
1:30 PM - 2:05 PM
The digital transformation within regulatory agencies, particularly the FDA, Health Canada and European Notified Bodies, has marked a pivotal shift in MedTech regulatory processes demanding a new model of Regulatory Transformation.
2:05 PM - 2:40 PM
2:05 PM - 2:40 PM
The speed and volume of digital health products under development is ever-increasing, and the deluge of AI innovations has only just begun. GenAI has promise and perils; how can regulatory innovators usher valuable GenAI into the regulatory space?
2:40 PM - 3:15 PM
2:40 PM - 3:15 PM
3:15 PM - 3:30 PM
3:15 PM - 3:30 PM
3:30 PM - 4:05 PM
3:30 PM - 4:05 PM
4:05 PM - 4:40 PM
4:05 PM - 4:40 PM
4:40 PM - 5:15 PM
4:40 PM - 5:15 PM
5:15 PM - 6:30 PM
5:15 PM - 6:30 PM
Wednesday, June 5
8:00 AM - 8:30 AM
8:00 AM - 8:30 AM
8:30 AM - 8:45 AM
8:30 AM - 8:45 AM
8:45 AM - 9:20 AM
8:45 AM - 9:20 AM
This seminar explores common gaps in medical device life cycle management processes from a regulatory standpoint, offering insights enhancing practices to mitigate risks and ensure compliance across key global markets.
9:20 AM - 9:55 AM
9:20 AM - 9:55 AM
Complexities of EU MDR, with strict demands and ever-shifting timelines, have some manufacturers evaluating a market departure, potentially creating a significant competitive advantage for those that remain. Why to stay and how to do it effectively.
9:55 AM - 10:30 AM
9:55 AM - 10:30 AM
10:30 AM - 10:45 AM
10:30 AM - 10:45 AM
10:45 AM - 11:20 AM
10:45 AM - 11:20 AM
This session provides a regional update for Asian market medical device/IVD registration & reimbursement.
11:20 AM - 11:55 AM
11:20 AM - 11:55 AM
11:55 AM - 12:30 PM
11:55 AM - 12:30 PM
12:30 PM - 1:30 PM
12:30 PM - 1:30 PM
1:30 PM - 2:05 PM
1:30 PM - 2:05 PM
2:05 PM - 2:40 PM
2:05 PM - 2:40 PM
2:40 PM - 3:15 PM
2:40 PM - 3:15 PM
3:15 PM - 4:00 PM
3:15 PM - 4:00 PM
4:00 PM
4:00 PM
Speakers
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 at the Hogan Lovells Law Offices. Hogan Lovells is located at 555 13th Street NW, Washington, DC. Please note that this is a secure building and you will need an official ID (drivers license, etc.) to be able to access the building and the meeting space.

What are the registration prices:

Individual Registrations - In-person On-site OR Virtual

  • Early bird registration is $695 - Available until March 31, 2024
  • Regular Registration is $895 - Available between April 1 - May 20, 2024
  • Late Registration is $1095 - Starting May 21, 2024

For group registrations (3 or more) a 50% discount will be applied to the registration price of each additional registration beyond the second person (Registrations 1 & 2 will be full price, each registration after will receive a 50% discount). Remember, in order to receive this discount, registrations MUST BE MADE AT THE SAME TIME. There will be no retroactive refunds of registration fees.

BEST VALUE!  Enterprise Hybrid Registration (Team): Limited in-person registrations + unlimited virtual access: This Corporate Registration allows TWO (2) In-person registrations PLUS unlimited access to virtual attendees from the same organization.

  • Early bird registration is $1795  - Available until March 31, 2024
  • Regular registration is $2295 - Available between April 1 - May 20, 2024
  • Late Registration is $2895 - Starting May 21,  2024

Enterprise Virtual Registration (Team): This Corporate Registration allows UNLIMITED access to virtual participants from the same organization for all sessions during the summit.

  • Early bird registration is $1795  - Available until March 31, 2024
  • Regular registration is $2295 - Available between April 1 - May 20, 2024
  • Late Registration is $2895 - Starting May 21,  2024

How can I become a presenter?

  • You can submit an educational session abstract for consideration
  • Deadline for submissions is February 15, 2024
  • Visit the Call for Abstracts page and complete your submission here.

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.