5th Annual

EU IVD Clinical & Regulatory Conference

October 19-20, 2023 | Brussels, Belgium

Brussels Marriott Hotel Grand Place

Master European IVD regulation requirements to execute compliant strategies for clinical trials & successful submissions

Program Overview

Lead organizational change to ensure clinical and regulatory processes are compliant with EU IVDR. Global regulatory stakeholders clarify guidance and best practices to demonstrate real-life product efficiency, including executing clinical trials that garner sufficient evidence. Exchange lessons learned in preparing technical files and benchmark appropriate budget and resource allocation with peers.

Foster a sense of collaboration and safely connect with peers and expert presenters at this intimately-sized program. Customize your experience and address your unique concerns during dynamic Q&A after each session. Our commitment to industry perspectives keeps the program focused on what matters and dynamic session formats allow you to stay engaged.

Countdown to the EU IVD Clinical & Regulatory Conference

Day(s)

Hour(s)

Minute(s)

Second(s)

Experience the Quality First Difference.

Learn from Industry Leaders

An exclusive experience with professional thought leaders provides you with direct insight into current solutions.

Keep up with Industry Trends

Learn through dynamic panel discussions, case studies and real world evidence on current topics directly related to your industry.

Exchange Ideas & Network

We provide a platform for your team to ask questions with experienced industry experts. The key to building your knowledge and seeing things from another perspective.

Find Solutions that Work for You

Insight and interaction are at the ready for you and your team. Collaborate with your peers, utilizing their insight and experience to accommodate your common challenges.

“Many thanks for all your efforts on running this program…a well-deserved toast! Certainly do share our grateful sentiment to your other ‘Dream Team’ colleagues as well.”

Jennifer Dacpano-Komansky, Director Global Regulatory Affairs, Medical Devices, Novartis

Distinguished Presenters Include:

Philippe Auclair
Sr Dir. Regulatory Strategy, Abbott Quality & Regulatory
ABBOTT

Marta Carnielli
Head of Certification IVD
TÜV SÜD

Judith Prevoo
Regulatory Lead
BSI GROUP

Melissa Finocchio
Former Chief Regulatory Officer
SOPHiA GENETICS

Andrew Rutter
Senior Manager, Regulatory Affairs
QUIDELORTHO

Catherine Holzmann
Certification Division Manager IVDs
G-MED

View Full Agenda

Join our LinkedIn Group to stay up-to-date on our community

The Q1 Productions Event Experience

Are You a Solution Provider?

Reach out to us here.

A Special Thanks to Our Sponsors:

Media Partner:

“It was a fun to be part of a well-organized event and in the company of knowledgeable industry professionals, thanks again!”

Andrew Surprenant, International QA Compliance Manager, Instrumentation Laboratory

Attendees by Job Title

Director

Manager

Other

Attendees by Years of Experience

20+ Years

15-20 Years

10-15 Years

Less than 10 Years

Attendees by Company Size

10k+

1k-10k

Less than 1k

Reach out to us with any questions.

Our team will respond promptly!

Aaron Van Dyke
Operations Director, Life Science
Q1 Productions
312-840-9086
avandyke@q1productions.com

www.q1productions.com

AKRA TEAM is a consultancy company which was founded in 2021 by Dr. Bassil Akra to support various healthcare system stakeholders in achieving their target in a highly regulated business area. The focus of AKRA TEAM is to support medical device, in-vitro diagnostic and combination device innovators, companies, notified bodies and regulators finding a practical and reasonable approach to fulfill legal obligations. AKRA TEAM was established to make a difference and ensure that patients receive safe and effective devices in a timely manner.

Visit Sponsor Website

At Veranex, we can help you with concept through to commercialization by enabling:
• Accelerated speed to market
• Controlled development costs
• Development risk mitigation
• Market viability assessment

At every stage, we navigate our clients to realize efficiencies in cost and time with our integrated and comprehensive solutions.

Visit Sponsor Website

Precision for Medicine specializes in IVD & CDx services, offering a wide range of expertise, including global strategic planning, regulatory communications, analytical validation, and clinical trial submission support in both Europe and the US. With a wealth of experience spanning various therapies and technologies, we ensure compliance and success within the IVD industry.

As a global, full-service precision medicine clinical research organization (CRO), we seamlessly integrate clinical operations, laboratory expertise, and advanced data sciences to expedite clinical development and approval. Supported by seven specialty labs and a diverse global team of over 3,000 professionals, we are at the forefront of innovation in IVD solutions.

Visit Sponsor Website

SMART-TRIAL by Greenlight Guru is a modern clinical data collection toolbox, purposefully built for MedTech. Collect and manage clinical data in pre and post-market clinical studies, including registries, cohorts, surveys, human factor testing, design validation, and more. SMART-TRIAL meets the regulatory requirements of the FDA, EU, and most other countries, and ensures compliance out-of-the-box with GCP and ISO 14155:2020

Visit Sponsor Website

We are award-winning IVD and medical device headhunters, recruiters and talent managers. We recruit exceptional people that solve regulatory and compliance problems, so patients all over the world can, have access to safe, innovative and life-changing medical devices.

Our team enables companies to achieve their business goals by attracting, hiring and retaining some of the industry’s top talent. Through our network, companies get access to valuable data insights, salary surveys, talent trends and knowledge on how to build a diverse global workforce.

Visit Sponsor Website

Since TrainingPros was founded in 1997, we have been dedicated to helping our clients find the right consultant for their projects. 25 years later, we are proud to have helped hundreds of clients complete their projects and thousands of consultants find great assignments. We continue to focus on helping our clients and consultants as well as our community as a certified women-owned, award-winning staffing company that works exclusively with Learning & Development professionals to match consultants to client projects.

Visit Sponsor Website

TELCOR is the proven leader of health care software solutions for revenue cycle management (RCM) software and services designed specifically for laboratories. TELCOR RCM, our SaaS solution, and TELCOR Revenue Cycle Services, our billing service, are designed to streamline workflow, improve collections, and provide real-time analytics. Our software and service solutions are designed for the unique challenges and requirements of laboratory specialties and the clients they serve. With full access to data, labs have complete visibility of their data and can track key performance indicators. No other vendor works as hard ensuring you get paid for the work you do.

Visit Sponsor Website

At Tipping Point Media, we pride ourselves on developing innovative, creative, and technically advanced virtual training and digital marketing solutions for the life sciences industry.

We push the limits of what's possible using Augmented and Virtual Reality to create revolutionary experiences proven to increase audience engagement and retention rates.

Our dedicated team of educators, medical experts, certified programmers, and digital renaissance innovators are committed to creating high-quality custom creations that bring your company's vision to life.

Visit Sponsor Website

VantagePoint Performance trains Salespeople to be more fluent and comfortable across different situations needing different sales approaches, and we train Sales Managers to be better coaches and team leaders, with more focus and less stress.

We’re different from the average sales training company because:

We don’t believe that one approach, one system, or one methodology is absolutely superior. All have something to offer, and the “best approach” or “best system” depends on the sales situation. This is what our applied, academic research tells us.
Our use of data science, specifically Machine Learning, helps us learn about our clients more meaningfully. We provide insights from each client’s data to help them understand what drives the success of their top-performing Salespeople and Sales Managers.
We are constantly feeding what we learn back into our training products, and we invest a bigger slice of our total energy into this innovation than the average sales training company. Our clients can access always-refreshed intellectual property and content through our training subscriptions.

Visit Sponsor Website

Policy Reporter, acquired by TrialCard in 2019, provides innovative healthcare software solutions to track payer policies in near real-time and enhances market access for the therapies patients need most. The company’s patented software-driven solutions include a suite of billing and reimbursement tools for providers and laboratories, market intelligence tools for payers, and a suite of market access solutions for life science companies. Its clients include some of the world’s largest pharmaceutical and healthcare companies.

Visit Sponsor Website

5th Annual

EU IVD Clinical & Regulatory Conference

October 19-20, 2023 | Brussels, Belgium

Master European IVD regulation requirements to execute compliant strategies for clinical trials & successful submissions

Program Overview

Countdown to the EU IVD Clinical & Regulatory Conference

Experience the Quality First Difference.

Learn from Industry Leaders

Keep up with Industry Trends

Exchange Ideas & Network

Find Solutions that Work for You

“Many thanks for all your efforts on running this program…a well-deserved toast! Certainly do share our grateful sentiment to your other ‘Dream Team’ colleagues as well.”

Jennifer Dacpano-Komansky, Director Global Regulatory Affairs, Medical Devices, Novartis

Distinguished Presenters Include:

Philippe Auclair Sr Dir. Regulatory Strategy, Abbott Quality & Regulatory ABBOTT

Marta Carnielli Head of Certification IVD TÜV SÜD

Judith Prevoo Regulatory Lead BSI GROUP

Melissa Finocchio Former Chief Regulatory Officer SOPHiA GENETICS

Andrew Rutter Senior Manager, Regulatory Affairs QUIDELORTHO

Catherine Holzmann Certification Division Manager IVDs G-MED

Join our LinkedIn Group to stay up-to-date on our community

The Q1 Productions Event Experience

Are You a Solution Provider?

Reach out to us here.

A Special Thanks to Our Sponsors:

Media Partner:

“It was a fun to be part of a well-organized event and in the company of knowledgeable industry professionals, thanks again!”

Andrew Surprenant, International QA Compliance Manager, Instrumentation Laboratory

Attendees by Job Title

Director

Manager

Other

Attendees by Years of Experience

20+ Years

15-20 Years

10-15 Years

Less than 10 Years

Attendees by Company Size

10k+

1k-10k

Less than 1k

Reach out to us with any questions.

Our team will respond promptly!

Aaron Van Dyke Operations Director, Life Science Q1 Productions 312-840-9086 avandyke@q1productions.com

Philippe Auclair
Sr Dir. Regulatory Strategy, Abbott Quality & Regulatory
ABBOTT

Marta Carnielli
Head of Certification IVD
TÜV SÜD

Judith Prevoo
Regulatory Lead
BSI GROUP

Melissa Finocchio
Former Chief Regulatory Officer
SOPHiA GENETICS

Andrew Rutter
Senior Manager, Regulatory Affairs
QUIDELORTHO

Catherine Holzmann
Certification Division Manager IVDs
G-MED

Aaron Van Dyke
Operations Director, Life Science
Q1 Productions
312-840-9086
avandyke@q1productions.com