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 * AGENDA Menu Toggle
   * Agenda Request
 * SPEAKERS Menu Toggle
   * Our Speakers
   * Speaker Opportunities
 * SPONSOR Menu Toggle
   * Sponsorship Request
 * TESTIMONIALS
 * VENUE
 * OUR EVENTS

 * 22nd-23rd November 2023
 * Sheraton Brussels Airport Hotel, Belgium


3RD ANNUAL EUROPEAN MEDICAL DEVICE & DIAGNOSTIC REGULATORY AFFAIRS CONFERENCE

 * 22nd-23rd November 2023
 * Sheraton Brussels Airport Hotel, Belgium


3RD ANNUAL EUROPEAN MEDICAL DEVICE & DIAGNOSTIC LABELLING AND UDI CONFERENCE


WE INTERACT TOGETHER. INNOVATE TOGETHER. INSPIRE TOGETHER.


TT REGULATORY AFFAIRS

The 3rd Annual European Medical Device and Diagnostic Regulatory Affairs
Conference is the most comprehensive conference focusing on the latest
regulatory development and challenges in healthcare products in Europe and
beyond. With a diverse set of speakers and a range of industry perspectives, the
two-day conference will share practical methods to strengthen regulatory
strategies compliant with current standards. The thoughtfully designed agenda
will focus on addressing the recent amendment to the EU MDR transition period,
lessons learned in MDR and IVDR certifications, strategies for achieving timely
compliance for new & legacy devices, integrating risk files into technical
documentation, and gaining insights on successful product submissions.

The TT Regulatory Affairs conference is the opportunity to participate in highly
interactive presentations supported by real-life business examples and engage
with esteemed industry experts in real time. This intimate and interactive
knowledge-sharing platform, filled with live Q&As, roundtables, break-out
sessions, and a continual exchange of dialogue, delivers practical insight,
guidance, and real-world networking opportunities. Industry experts will discuss
common greys areas of regulatory challenges in European and global markets, UKCA
regulatory updates and post -swixit changes, the MDSAP program, PMCF activities,
global regulatory framework for AI – Based Medical devices and combination
devices.


TT LABELLING AND UDI

The 3rd Annual European Medical Device and Diagnostic Labelling and UDI
Conference will bring together the industry’s most brilliant minds under one
roof. This is a highly interactive platform to learn from the practical
experience of industry thought leaders and find solutions to the challenges that
are based on real-life business examples and case studies. This two-day
conference will uncover practical methods for complying with evolving labelling
& UDI requirements, how to enhance operational management of label development &
approval, explore software & tools to support labelling needs, assess guidance
for eIFUs, examine EUDAMED submissions, achieve CAPA & labelling change control
process improvements and the applicability of e-labels across global regions.

The TT LUDI Conference will be filled with informative presentations that will
provide deeper insights on how to improve labelling and UDI processes to ensure
compliance, manage space constraints, assess labelling translation issues,
improve UDI data usability, and create sustainable global UDI compliance &
master data strategy and IFU content optimization. Attendees will get an
opportunity to engage with counterparts in real-time and address unique concerns
during live Q&A, interactive roundtables and breakout sessions and walk away
with actionable insights to ensure success.

 

Request Agenda
Request Both Agendas
Request Agenda


TT REGULATORY AFFAIRS

The 3rd Annual European Medical Device and Diagnostic Regulatory Affairs
Conference is the most comprehensive conference focusing on the latest
regulatory development and challenges in healthcare products in Europe and
beyond. With a diverse set of speakers and a range of industry perspectives, the
two-day conference will share practical methods to strengthen regulatory
strategies compliant with current standards. The thoughtfully designed agenda
will focus on addressing the recent amendment to the EU MDR transition period,
lessons learned in MDR and IVDR certifications, strategies for achieving timely
compliance for new & legacy devices, integrating risk files into technical
documentation, and gaining insights on successful product submissions.

 

The TT Regulatory Affairs conference is the opportunity to participate in highly
interactive presentations supported by real-life business examples and engage
with esteemed industry experts in real time. This intimate and interactive
knowledge-sharing platform, filled with live Q&As, roundtables, break-out
sessions, and a continual exchange of dialogue, delivers practical insight,
guidance, and real-world networking opportunities. Industry experts will discuss
common greys areas of regulatory challenges in European and global markets, UKCA
regulatory updates and post -swixit changes, the MDSAP program, PMCF activities,
global regulatory framework for AI – Based Medical devices and combination
devices.

Request Agenda


TT LABELLING AND UDI

The 3rd Annual European Medical Device and Diagnostic Labelling and UDI
Conference will bring together the industry’s most brilliant minds under one
roof. This is a highly interactive platform to learn from the practical
experience of industry thought leaders and find solutions to the challenges that
are based on real-life business examples and case studies. This two-day
conference will uncover practical methods for complying with evolving labelling
& UDI requirements, how to enhance operational management of label development &
approval, explore software & tools to support labelling needs, assess guidance
for eIFUs, examine EUDAMED submissions, achieve CAPA & labelling change control
process improvements and the applicability of e-labels across global regions.

 

The TT LUDI Conference will be filled with informative presentations that will
provide deeper insights on how to improve labelling and UDI processes to ensure
compliance, manage space constraints, assess labelling translation issues,
improve UDI data usability, and create sustainable global UDI compliance &
master data strategy and IFU content optimization. Attendees will get an
opportunity to engage with counterparts in real-time and address unique concerns
during live Q&A, interactive roundtables and breakout sessions and walk away
with actionable insights to ensure success.

 

Request Agenda
Request Both Agendas
Request Both Agendas


OUR INDUSTRY SPECIALISTS


TT REGULATORY AFFAIRS


FRANK MATZEK


VICE PRESIDENT REGULATORY AND GOVERNMENTAL AFFAIRS


BIOTRONIK SE & CO. KG


LYUDMILA GLUSHKOVA


DIRECTOR REGULATORY AFFAIRS EMEA


HOYA SURGICAL OPTICS


CARINE COCHEREAU


VICE PRESIDENT, REGULATORY AFFAIRS INTERNATIONAL


INTEGRA LIFESCIENCES


OLEG YUSIM


SR. DIRECTOR, PRODUCT SECURITY


EDWARDS LIFESCIENCES


SOUNDHARYA NAGASUBRAMANIAN


VP OF CONNECTIVITY AND DATA MANAGEMENT


VAPOTHERM


CHRISTOPHER FRENZ


AVP OF IT SECURITY


MOUNT SINAI SOUTH NASSAU


TT LABELLING & UDI


DARREN MANSELL


REGULATORY AFFAIRS MANAGER


OWEN MUMFORD


RICKY WONG


ASSOCIATE, REGULATORY PROJECTS


MED-EL


GINTARĖ VALENTINAVIČIŪTĖ


REGULATORY AFFAIRS SPECIALIST, SOFTWARE


3SHAPE


RAJAGOPALAN SRINIVASAN


DIRECTOR, SOFTWARE ENGINEERING


VITARA BIOMEDICAL, INC


CHRISTOPHER CAMPBELL


DIRECTOR OF SOFTWARE AND SENSORS


DEPUY SYNTHES (JOHNSON&JOHNSON)


SARAH BILALI


DIRECTOR OF GLOBAL REGULATORY AFFAIRS - DIGITAL DEVICES


UCB

CONFERENCE SPEAKERS


TARGETED CONTENT

With our targeted attendee and speaker line-up, you can have meaningful
conversations with industry-specific experts who have faced the same situations
and challenges. Spark new ideas by brainstorming during our breakout sessions,
informal post-session Q&As, panel debates, case studies, and workshops.


MEET INDUSTRY LEADERS

Our robust screening process ensures an exclusive environment where you can
focus on connecting and fostering stronger working relationships with those in
the medical device field. Collaborate to find the necessary solutions to your
current problems.


CUSTOMIZE YOUR CONTENT

Get the most out of this event experience by choosing what content is most
relevant for you and your company and tailoring your event experience around
this decision. Learn and connect with whomever you want, whenever you want, and
however you want.




IF YOU ARE A PART OF THE MEDICAL DEVICE REGULATORY AFFAIRS AND LABELLING & UDI
COMMUNITY, TT RADL GUARANTEES A VALUABLE RETURN ON TIME INVESTED.

Register


YOU'RE IN GOOD COMPANY


Register



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Phone: +44 20 3059 2911

Email: info@ttgw.co.uk

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Uxbridge

UB8 1EX


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