Outsourcing in Clinical Trials: Medical Devices Europe 2023

The 2023 programme will offer a fresh insight into the latest regulatory updates, global clinical trials, advanced technologies such as digital health and connected devices space, and more. With presentations and panel discussions on all the hottest industry trends and outsourcing challenges.

21 - 22

February

2023
  • Holiday Inn Munich City Centre, Munich, Germany
  • Complimentary

Why attend?

The meeting place for healthcare pioneers and innovators

Join medical device experts to discuss new trends and opportunities and learn how to optimize their clinical operation knowledge and stay ahead of the game. Find the right solution providers to partner with to accelerate your trial timelines.

175+

Attendees

20+

Exhibitors

20+

Speakers

82%

Attendees at Director+ Level

175+

Attendees

20+

Exhibitors

20+

Speakers

82%

Attendees at Director+ Level

See What It's All About

Agenda

  • 21 Feb 2023
  • 22 Feb 2023
Expand All

8 AM

Registration & Refreshments

8:55 AM

Chairman’s Opening Remarks

9 AM

How to build a good relationship with your clinical trial site and how it can improve clinical trial performance

  • Highlighting the role that the clinical trial site plays and how to work with the site during the planning phase
  • How to ensure a study will stand out at a clinical trial site
  • Exploring some key advice on how to get the most out of your site
  • Focus points moving forwards, how both CRO’s and sponsors can work with a site to improve the quality of a trial

Speakers

9:30 AM

Preparing for Medical Device Approval: Strategies for Meeting US and European Regulatory Standards

  • Current advancements and projected schedules for EU MDR conformity
  • Tactics for tackling significant obstacles encountered by the industry
  • The digital transition imperative to competently abide by EU MDR regulations and surpass them

Speakers

10 AM

A New Phase In Good Clinical Practice: Are We Ready To Implement All Aspects Of ICO 2020 Requirements?

  • What are the shifts in the scope of requirements on clinical investigations?
  • Working on the connection between Good Clinical Practice requirements together with other standards and MDR?
  • Unveiling experience with dealing with ethics committees and competent authorities under new set of requirements

Speakers

10:30 AM

Morning Refreshments and Networking

11 AM

Navigating operational challenges for start-ups starting their clinical journey

  • Exploring all the lessons learned from two digital health start ups
  • Finding committed clinical partners for trials
  • Designing trials for reimbursement, not (only) regulatory
  • From retrospective to prospective trials, from structural to functional endpoints

Speakers

11:30 AM

Post Market Clinical Follow-up: Dealing with the rising costs of clinical trials

  • Why collecting high-quality and relevant data from outside EU can be a cost-effective solution?
  • How do Notify Bodies view data from outside the EU?
  • How to ensure you are collecting high-quality and relevant data from sites outside EU?

Speakers

12 PM

Effectively Using Patient Reported Outcomes (Pros) To Garner Quality Clinical Data

  • Patient Reported Outcomes: the new frontier of real-world evidence
  • Planning and setting up a well-defined process to garner quality data from PROs
  • Addressing ongoing challenges to improve the feasibility of patient reporting
  • Case study – Data collected from patient survey
  • How this survey helped to meet the evidence requirements and demonstrate the safety and performance of the device according to the clinical benefits

Speakers

12:30 PM

Lunch

1:30 PM

Is There Any Room For Innovation During The Era Of MDR? Ensuring Competitiveness And Innovation During Uncertain Regulations

  • Understanding the significant impact of MDR on innovation in medical device industry
  • Is the innovation moving to the US: Uncovering the impact of MDR on the European market
  • Assessing practical solutions in compliance with competent authorities and ethics committee

Speakers

2 PM

EU MDR: How Attractive is Europe for Innovation

  • What are the main regulatory challenges for new medical devices after EU MDR?
  • How MedTech companies are reacting?
  • Is CE-mark still "first choice" by start-ups and SMEs

Speakers

2:30 PM

Addressing the main hurdles when starting a PMCF trial in the EU

Speakers

3 PM

Afternoon Networking & Refreshments

3:30 PM

Uncovering the benefits of remote monitoring in modern trials

  • Exploring the place that remote trials have in the modern clinical world
  • Reviewing the positives and negative aspects of remote patient and data monitoring
  • What are the operational challenges of reviewing data remotely compared to site visits
  • Do we lose an element of trust when we take away the site relationship?

Speakers

4 PM

Advancing Digital Technologies in Daily Study Management

  • Regulatory requirements and increasing demand for digital technologies
  • Commonly seen digital technologies for study integration
  • Challenges implementing digital technologies
  • The future of digital technologies

Speakers

4:30 PM

The challenges of IVDR for small and medium enterprises – from the point of view of a notified body and of a manufacturer

  • Working within the new regulations as a smaller enterprise
  • A case study presented by a manufacturer, how to successfully submit your trial data

Speakers

5 PM

Case Study: How to bring your product out to the market through clinical trials.

  • Finding alternatives outside of the EU and US to start off a clinical cycle
  • Working with first in human trials as a way to prove safety and efficacy
  • The possibilities of working without a CRO at the early stages of clinical testing

Speakers

5:30 PM

Chairman’s Closing Remarks & Drinks Reception

8:30 AM

Registration and Refreshments

8:50 AM

Chair’s Opening Remarks

9 AM

Speaker Hosted Roundtables

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables

RT1 Discussing The Current Issues With Efficient Supply Chain Management For Clinical Trials Of Medical Devices

Sandra Kohler, Director of Clinical Ops, Xeltis

RT2 Addressing The Challenges With MDR: How to Plan the Clinical Investigation for a Medical Device To Generate an Appropriate Evidence Compliant with the New Regulation?

Yana Arlouskaya, Project Manager for Clinical Investigations, Paul Hartmann AG

RT3 Developing Effective Procedures For Study Risk Management In Your Medical Device Trial

Danish Mairaj, Principal Engineer Medical Device Design, Resyca

RT4 Developing Effective Vendor Management Tools to Oversee Your Clinical Investigation

Dr Hans-Heinrich Nickell, Business Development Consultant, Qmed Consulting

Speakers

10 AM

Morning Refreshments and Networking

10:30 AM

Panel: CROs As Partners: How To Find Best CRO According To Your Requirements?

  • Understanding the benefits of long term partnership with CROs
  • How can the CROs help medical manufacturers to expand their studies outside Europe?
  • Ensuring efficient CRO selection: Are CROs up to date with new MDR regulations?
  • Discovering different ways to engage with CROs
  • Unveiling the changing CRO requirements for companies with different sizes

Speakers

11 AM

Finally obtained CE certification, what is needed next?

  • How to collect PMCF clinical data for your device to stay CE marked on the market.
  • What are your options?

Speakers

11:30 AM

Is Innovation In Medical Devices Industry Dependent On Smaller Firms? Understanding The Impact Of MDR On The Dynamics Of Medical Industry

  • Does the high levels of bureaucracy prevent innovation driven by smaller firms?
  • Unveiling the impact of liquidity issues on medical device innovation
  • Is there a way out? Tackling the complexity of regulations for the sake of a more innovative medical device industry

Speakers

12 PM

Defining Sample Size for Pre- and Post-Market Clinical Activities

  • How to justify the sample size
  • How to prepare for sample size calculation
  • How clinical experience influences sample size

Speakers

12:30 PM

Networking Lunch

1:30 PM

Case Study – How to improve the outcome of clinical performance studies of IVD products by meeting EN 62366 12015 A12020 standard

  • Discussing some of the main challenges of meeting the new standards with IVD products
  • How to get the most out of your product and ensure that the user is able to work with the device easily

Speakers

2 PM

Reserved for IQVIA MedTech

2:30 PM

Growing Trends on the Use of RWE for Clinical Development

  • Understanding how the regulatory landscape is evolving, with growing acceptance of RWE by regulators around the world
  • The increasing usage of Real World Evidence and Real World Data will be explored in a global context

Speakers

3 PM

Fireside Chat: Tackling The Reasons For A Much Needed Change: Benefits Of Inclusive Terminology For Patient Documentation In Med-Device Clinical Trials:

  • A look at current ISF patient documentation policy: Is it really inclusive?
  • How does a gender bias affect the medical device clinical trials?
  • Understanding the benefits of an inclusive terminology for medical devices

Speakers

3:30 PM

Close of Conference

Speakers

Select a speaker to learn more

Back
Renata Čížková
Head of Clinical Department, , ELLA-CS

Session Details:

Is Innovation In Medical Devices Industry Dependent On Smaller Firms? Understanding The Impact Of MDR On The Dynamics Of Medical Industry

2023-02-22, 11:30 AM

View In Agenda
Next speaker
Back
Sandra Kohler
Director Of Clinical Ops, Xeltis

Session Details:

Speaker Hosted Roundtables

2023-02-22, 9:00 AM

Session Details:

Panel: CROs As Partners: How To Find Best CRO According To Your Requirements?

2023-02-22, 10:30 AM

View In Agenda
Next speaker
Back
Yana Arlouskaya
Project Manager For Clinical Investigations, Hartmann Group

Session Details:

Speaker Hosted Roundtables

2023-02-22, 9:00 AM

View In Agenda
Next speaker
Back
Enrico Perfler
CEO, 1MED SA

A biomedical engineer by training, Mr. Perfler has 18 years of professional experience specialising in medical device technology and, with his company, has overseen the development and regulatory approval of over 500 medical devices.

In 2014, he founded 1MED SA, a dynamic international company providing regulatory support, digital solutions and full-service CRO support to the medical device and pharmaceutical industry with a focus on IVD and medical products.

Mr. Perfler is also a contract professor of “Regulatory Affairs” at University of Pavia, Faculty of Engineering and an active contributor to the ISO technical committee for the biological evaluation of medical devices.

Session Details:

EU MDR: How Attractive is Europe for Innovation

2023-02-21, 2:00 PM

View In Agenda
Next speaker
Back
Jana Meschede
Project Manager, ZEISS Medical
Next speaker
Back
Danish Mairaj
Principal Engineer Medical Device Design, Resyca

Session Details:

Speaker Hosted Roundtables

2023-02-22, 9:00 AM

View In Agenda
Next speaker
Back
Deborah-Ann Schuster
Clinical Project Manager, Hospital Patient Monitoring, Phillips

Session Details:

Is There Any Room For Innovation During The Era Of MDR? Ensuring Competitiveness And Innovation During Uncertain Regulations

2023-02-21, 1:30 PM

View In Agenda
Next speaker
Back
Aude Yulzari
Clinical Affairs Manager, Precisis

Session Details:

Addressing the main hurdles when starting a PMCF trial in the EU

2023-02-21, 2:30 PM

View In Agenda
Next speaker
Back
Chems Hachani
CEO, ECLEVAR MEDTECHECH

Session Details:

Post Market Clinical Follow-up: Dealing with the rising costs of clinical trials

2023-02-21, 11:30 AM

View In Agenda
Next speaker
Back
Luana Clerico
Clinical & Medical Affairs Director, Polytech

Session Details:

Effectively Using Patient Reported Outcomes (Pros) To Garner Quality Clinical Data

2023-02-21, 12:00 PM

View In Agenda
Next speaker
Back
Pavel Kusnierik
Head Of Regulatory Affairs, Contipro

Session Details:

A New Phase In Good Clinical Practice: Are We Ready To Implement All Aspects Of ICO 2020 Requirements?

2023-02-21, 10:00 AM

View In Agenda
Next speaker
Back
Hans-Heinrich Nickell
Business Development Consultant, Qmed Consulting

Dr. Hans-Heinrich Nickell has more than 20 years of experience in clinical development support for pharmaceutical companies, biotech, medical device and vaccine industries. He holds a degree in Pharmacy from the Philipps University in Marburg and a degree for Human Medicine from the Albert-Ludwigs University in Freiburg. After clinical work as a medical doctor at the University Clinic in Lübeck he started his career in 1995 in the pharmaceutical industry working for biotech companies. From 1999 he has worked in Business Development for major CROs with a focus on Medical Devices, CNS, Infectious Diseases, Immunotherapy, Vaccines and Oncology.

Next speaker
Back
Laia Casas Papiol
Clinical Project Leader, Noucor Health

Biomedical Scientist with an MSc in Monitoring Clinical trials and Medical Affairs. Have worked in several positions from top to bottom: From study coordinator to RD Project Manager at a Sponsor Company, including CRA. Work through various companies: Pharmaceutical laboratories, CROs and medical device start-ups. Have worldwide experience in clinical trials, and planned, designed, and led clinical projects for EMA and FDA.

 

Session Details:

Fireside Chat: Tackling The Reasons For A Much Needed Change: Benefits Of Inclusive Terminology For Patient Documentation In Med-Device Clinical Trials:

2023-02-22, 3:00 PM

View In Agenda
Next speaker
Back
Fiona Maini
Senior Director, Global Compliance and Strategy, Medidata

Session Details:

Preparing for Medical Device Approval: Strategies for Meeting US and European Regulatory Standards

2023-02-21, 9:30 AM

View In Agenda
Next speaker
Back
Claire Woodthorpe
Chief Operating Officer, Lightpoint Medical

Session Details:

Uncovering the benefits of remote monitoring in modern trials

2023-02-21, 3:30 PM

View In Agenda
Next speaker
Back
Jón I. Bergsteinsson
Founder, SMART-TRIAL by Greenlight Guru

Jón I. Bergsteinsson, M.Sc. Biomed. Eng. is the VP of Global Business Development and the co-founder of SMART-TRIAL, he also served as the CTO until 2017 where he paved the way for the platform’s quality standards, data security, and compliance. With a strong technical background, and 10 years of experience in clinical informatics, research, and medical devices, Jón’s primary mission is to share valuable insights and know-how on clinical data management with the MedTech industry.

Session Details:

Defining Sample Size for Pre- and Post-Market Clinical Activities

2023-02-22, 12:00 PM

View In Agenda
Next speaker
Back
Wouter Mattheussens
Junior Clinical Project Manager, QServe, Quentin MD

Session Details:

Finally obtained CE certification, what is needed next?

2023-02-22, 11:00 AM

View In Agenda
Next speaker
Back
Marta Carnielli
Head Of Certification, TÜV SÜD

Session Details:

The challenges of IVDR for small and medium enterprises – from the point of view of a notified body and of a manufacturer

2023-02-21, 4:30 PM

View In Agenda
Next speaker
Back
Karel Volenec
CEO, ELLA-CS

Session Details:

Is Innovation In Medical Devices Industry Dependent On Smaller Firms? Understanding The Impact Of MDR On The Dynamics Of Medical Industry

2023-02-22, 11:30 AM

View In Agenda
Next speaker
Back
Manuel Opitz
CEO, Deepeye Medical

Session Details:

Navigating operational challenges for start-ups starting their clinical journey

2023-02-21, 11:00 AM

View In Agenda
Next speaker
Back
Olli Keränen
CEO, Medtentia

Session Details:

Case Study: How to bring your product out to the market through clinical trials.

2023-02-21, 5:00 PM

View In Agenda
Next speaker
Back
Carlos Fuste
Medical Director Spain / France, Fidia Farmaceutici SpA

Session Details:

Growing Trends on the Use of RWE for Clinical Development

2023-02-22, 2:30 PM

View In Agenda
Next speaker
Back
Paulo Neves
Vice President Clinical And Medical Affairs, Xeltis

Session Details:

How to build a good relationship with your clinical trial site and how it can improve clinical trial performance

2023-02-21, 9:00 AM

View In Agenda
Next speaker
Back
Frank Keulen
Director, Program Delivery, Medical Device and Diagnostics, Premier Research

Session Details:

Advancing Digital Technologies in Daily Study Management

2023-02-21, 4:00 PM

View In Agenda
Next speaker
Back
Catherine Longworth
Editor, GlobalData
Next speaker
Back
Miron Tokarski
CEO, Genomtec

Session Details:

Case Study – How to improve the outcome of clinical performance studies of IVD products by meeting EN 62366 12015 A12020 standard

2023-02-22, 1:30 PM

View In Agenda
Next speaker
Back
Dr Camilla Fleetcroft
VP Clinical & Regulatory Affairs, Ex-MHRA Deputy Director Medical Devices. ECLEVAR UK
Next speaker

Plan Your Visit

Holiday Inn Munich City Centre

Holiday Inn Munich City Centre, Munich, Germany Hochstrasse 3, Munich, Germany, 81669

Accommodation

Please be aware that should you be contacted by any 3rd party housing companies that they are not affiliated with us or the hotel

Sponsors

Select a sponsor to learn more

FEATURED SPONSOR

SESSION SPONSORS

EXHIBITORS

ROUNDTABLE SPONSOR

CO-SPONSOR

Enquiry

Contact Us

SPONSORSHIP ENQUIRIES

Nick McCudden

Head of OCT Events

+61 280 978 126

SPEAKING OPPORTUNITIES

Douglas Webber

Conference Producer

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

SPONSORSHIP ENQUIRIES

To enquire about sponsorship opportunities for the conference, please contact:

Nick McCudden

Head of OCT Events


+61 280 978 126

SPEAKER ENQUIRES

To enquire about speaking opportunities for the conference, please contact:

Douglas Webber

Conference Producer


+(44) 20 7866 9411