14th Annual Outsourcing in Clinical Trials: Medical Devices Europe 2026

Uniting expertise and innovation to shape the future of medical device and diagnostic trials

27 - 28

January

2026
  • Holiday Inn Munich City Centre, Munich, Germany
  • Complimentary
  • Agenda
  • Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Resources
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  • Contact Us
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The meeting place for healthcare pioneers and innovators

➠ Meet and hear from key MedTech manufacturers and solution providers in order to streamline your clinical processes and accelerate your overall trial timelines

➠ Hear from 15+ clinical operations and regulatory affairs professionals from medical device manufacturers on a range of topics around running a trial effectively, working with CROs and navigating regulations

120+

Attendees

20+

Exhibitors

15+

Speakers

120+

Attendees

20+

Exhibitors

15+

Speakers

Agenda

  • 27 Jan 2026
  • 28 Jan 2026
Expand All

Streams

Stream one

STREAM A: Medical Device Trials & Evidence

Stream two

STREAM B: In Vitro Diagnostics Performance & Validation

11:30 AM

CASE STUDY Validating digital diagnostics and complying with both IVDR and the AI Act

  • Streamlining evidence generation without duplicating AI and IVDR submissions
  • Understanding notified body expectations for performance claims and bias mitigation
  • Identifying realistic validation methods for early-stage digital diagnostics

Speakers

Dr. Philipp Schatz
Global Regulatory Leader – IVD, Bayer 12:00

12 PM

Session reserved for event sponsor

12:30 PM

Harmonizing IVD standards with regulatory requirements under IVDR

  • Aligning ISO 20916 with IVDR to avoid duplication in performance study design
  • Understanding the evolving role of harmonized and common specifications in supporting clinical evidence generation
  • Identifying opportunities to simplify documentation and testing

Speakers

Dr. Fatima Bennai-Sanfourche
Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

1 PM

Lunch and networking

2 PM

Coordinating IVD and therapeutic evidence in combined clinical trials

  • Aligning regulatory timelines and clinical strategies when diagnostics and therapeutics are evaluated together
  • Managing divergent requirements across IVDR, MDR, and pharmaceutical frameworks
  • Leveraging historical data, bridging strategies, and COMBINE project insights to support integrated evidence generation

Speakers

Mojca Valjavec
Regulatory Affairs MD & IVD, Biocartis

2:30 PM

Navigating the new competent authority application process for companion diagnostics under IVDR

  • Understanding the updated competent authority application pathway for CDx under IVDR
  • Sharing lessons learned from real-world submissions and post-application interactions
  • Identifying best practices for aligning diagnostic and therapeutic regulatory timelines when engaging with authorities

Speakers

Sarah Johnson
VP, Head of Clinical Affairs, QIAGEN

3 PM

PANEL DISCUSSION Getting innovative devices approved in today’s regulatory landscape

  • Exploring options when traditional clinical data requirements cannot be fully met at submission
  • Establishing a robust clinical strategy using early dialogue, risk-based justification and post-market commitments
  • Leveraging expert panels, NB consultations and scientific advice to de-risk approval pathways

Speakers

Jens Pfannkuche
Director Regulatory Affairs, Penumbra
Dr. Manuela Stauss-Grabo
Senior Vice President and Head of Clinical Research, Fresenius Medical Care

3:30 PM

Afternoon refreshments and networking

4 PM

Bridging legacy IVD devices to IVDR clinical expectations

  • Translating past performance data into IVDR-compliant clinical evidence
  • Substantiating full intended purpose claims across settings and populations
  • Avoiding delays by proactively identifying outdated or missing data

 

Speakers

Jens Pfannkuche
Director Regulatory Affairs, Penumbra

4:30 PM

Session reserved for event sponsor

5 PM

Using PMPF to expand intended purpose and strengthen clinical claims

  • Designing general-purpose PMPF studies to validate new settings, claims, or patient population
  • Addressing gaps from initial submissions and identifying emerging risks
  • Using PMCF outcomes to support intended purpose expansion or claim updates

TBC - Chaohui Guo, Head of Clinical Validation, Roche

8:15 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

Dr. Fatima Bennai-Sanfourche
Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

9 AM

Strengthening your trial strategy with HTA-aligned evidence

  • Design trials that support both CE marking and joint clinical assessment
  • Anticipate payer expectations when choosing clinical endpoints
  • Avoid duplicative evidence generation by aligning early

Speakers

Marco Marchetti
Co-Chair of the European Commission's HTA Coordination Group, European Commission

9:30 AM

Session reserved for event sponsor

10 AM

Adapting trial designs to global market realities

  • Align protocol design with MDR, FDA and global regulatory expectations
  • Manage endpoint variability across geographies without undermining quality
  • Avoid costly rework by building flexibility into trial strategy

 

Speakers

Dr. Manuela Stauss-Grabo
Senior Vice President and Head of Clinical Research, Fresenius Medical Care

10:30 AM

Session reserved for event sponsor

11 AM

Morning refreshments and networking

11:30 AM

PANEL DISCUSSION Meeting Notified Body expectations for clinical data in 2026

  • Understand how notified body reviews differ by organization
  • Learn what makes a CER or PMCF study “good enough” in practice
  • Avoid overcommitting with evidence plans that are too ambitious

Moderator
Dr. Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

Speakers

Dr. Fatima Bennai-Sanfourche
Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer
Richard Holborow
Global Head Clinical Compliance, BSI
Dr. Tonia Jeiter
Associate Director Clinical R&D, Alcon & Former Clinical Team Lead, TÜV SÜD
Dr. Ulrich Nitsche
Global Director Clinical Centre of Excellence, TÜV SÜD

12 PM

Session reserved for event sponsor

12:30 PM

Choosing the right partner for clinical success

  • Decide between full-service CROs, niche providers and consultants
  • Map your internal capabilities to your outsourcing needs
  • Streamline communication and accountability across vendors

Speakers

Autumn Lang, PhD, RAC
Director Clinical Affairs, deepeye Medical

1 PM

Lunch and networking

2 PM

Navigating clinical compliance challenges in emerging medical device technologies

  • Spotting compliance risks early for novel or AI-enabled devices
  • Best practices for bridging clinical and regulatory teams
  • Lessons from recent reviews and practical recommendations for sponsors

Speakers

Richard Holborow
Global Head Clinical Compliance, BSI

2:30 PM

PANEL DISCUSSION Building and scaling clinical affairs teams with the right expertise

  • Balance in-house teams with outsourced or consultant support
  • Define key roles from CER writing to PMCF strategy
  • Develop career pathways for growing clinical talent pools

Moderator
Dr. Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

Speakers

Dr. Fatima Bennai-Sanfourche
Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer
Karny Ilan
Co-Founder and CEO, Feminai
Dr Stephan Theinert
Head Clinical Development, Eyesense

3 PM

Leveraging retrospective data for CE marking and robust clinical evaluation under MDR

  • Sharing a practical case study on using retrospective clinical data to meet evidence requirements for CE marking
  • Demonstrating how to align historical data with current MDR expectations for robust clinical evaluation
  • Highlighting lessons learned, common pitfalls, and tips for ensuring Notified Body acceptance

Speakers

Dr Stephan Theinert
Head Clinical Development, Eyesense

3:30 PM

Afternoon refreshments and networking

4 PM

Simplifying PMCF with realistic and actionable strategies

  • Create lean survey strategies that deliver quality insights
  • Integrate PSURs, CERs and PMCF into a manageable system
  • Reduce documentation burden without losing regulatory value

Speakers

Maike Hiller
Clinical Development Lead, Philips

4:30 PM

Session reserved for event sponsor

5 PM

Q&A session: lessons learned from former Notified Body expert

  • See how to align robust clinical evidence for MDR from an NB perspective
  • Bridge the gap between reviewer expectations and sponsor realities
  • Optimize clinical trial design and submissions for smoother approval

Chair: Dr. Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

Speakers

Dr. Fatima Bennai-Sanfourche
Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer
Dr. Tonia Jeiter
Associate Director Clinical R&D, Alcon & Former Clinical Team Lead, TÜV SÜD

5:30 PM

Chairperson’s closing remarks

Speakers

Dr. Fatima Bennai-Sanfourche
Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

NETWORKING DRINKS

Registration and refreshments

8:45 AM

Chairperson’s opening remarks

Speakers

Pavel Kusnierik
Head, Regulatory Affairs, Contipro

9 AM

Planning evaluations that withstand reclassification and scrutiny

  • Future-proof your CERs against class shifts and MDR updates
  • Address challenges when intended purpose evolves with technology
  • Build defensible clinical arguments for AI-enabled systems

Speakers

Jie Jia
Medical Director, BU INS, Fresenius Kabi MedTech

9:30 AM

Generating the right evidence for AI-driven and predictive devices

  • Design prospective studies to validate clinical performance of AI
  • Clarify intended purpose and risk classification from the outset
  • Meet evolving regulatory expectations for AI-enabled systems

Speakers

Karny Ilan
Co-Founder and CEO, Feminai

10 AM

Session reserved for event sponsor

Speakers

David Burnham
Senior Vice President Strategic Alliance Management Syneos Health

10:30 AM

PANEL DISCUSSION Managing global regulatory divergence to enable faster approvals

  • Understanding the shifting roles of FDA NB NMPA and CDSCO
  • China’s emerging innovation ecosystem and regulatory evolution
  • Opportunities and blind spots in India and Asia Pacific regions

Speakers

Katrin Simioni
Deputy Head Clinical Operations, AO Foundation

11 AM

Morning refreshments and networking

11:30 AM

Aligning clinical trial execution with business objectives

  • Examining the “business behind clinical” and how operations leaders can demonstrate ROI, efficiency, and scalability
  • Meeting regulatory expectations while supporting commercial growth
  • Translating clinical results into business impact: internal KPIs that matter
  • Creating adaptable infrastructure for long-term clinical evidence generation

Speakers

Dr. Arne Böhling
Global Clinical Affairs Director, Mölnlycke Healthcare

12 PM

Session reserved for event sponsor

12:30 PM

Lunch and networking

1:30 PM

Enhancing clinical evaluation without overburdening

  • Leveraging pre-existing data to reduce duplication in MDR submissions
  • Avoiding overcommitment and scoping expectations with internal stakeholders
  • Case study: Streamlining CER updates for a legacy cardiovascular product

TBC - Adelina Chiaravalloti, Director, Regulatory Affairs and Clinical Evaluation, Corcym

2 PM

Tech Spotlight Session

2:15 PM

Tech Spotlight Session

2:30 PM

Modernising global data collection for observational and registry studies

  • Piloting practical tools and workflows for collecting high-quality data across international sites
  • Navigating local requirements and global compliance for multi-country observational programs
  • Integrating imaging, monitoring, and electronic trial master files to strengthen data integrity and site collaboration

Speakers

Katrin Simioni
Deputy Head Clinical Operations, AO Foundation

3 PM

Afternoon refreshments and networking and Prize Draw

3:30 PM

ROUNDTABLES PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the medical devices industry.

RT1 Proactive management of safety risks in clinical research
Talia Milosevic, Director, Clinical Safety, Surgical Structural Heart, Edwards Lifesciences

RT2 Structuring your clinical team for efficiency and growth
Dr Stephan Theinert, Head Clinical Development, Eyesense

RT3 Navigating questionable clinical data sets and strengthening quality assurance for device approvals
Anna Mayer, Clinical Auditor, TÜV SÜD

RT4 Fostering positive CRO relationships: tips and best practice

Speakers

Talia Milosevic
Director, Clinical Safety, Surgical Structural Heart, Edwards Lifesciences
Dr Stephan Theinert
Head Clinical Development, Eyesense
Anna Mayer
Clinical Auditor, TÜV SÜD

End of conference

Speakers

Select a speaker to learn more

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Marco Marchetti
Co-Chair of the European Commission's HTA Coordination Group, European Commission

Session Details:

Strengthening your trial strategy with HTA-aligned evidence

2026-01-27, 9:00 AM

View In Agenda
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Dr. Fatima Bennai-Sanfourche
Senior Director of QA & RA Compliance for Medical Devices and eHealth, Bayer

Session Details:

PANEL DISCUSSION Meeting Notified Body expectations for clinical data in 2026

2026-01-27, 11:30 AM

Session Details:

Chairperson’s opening remarks

2026-01-27, 8:50 AM

Session Details:

Chairperson’s closing remarks

2026-01-27, 5:30 PM

Session Details:

Harmonizing IVD standards with regulatory requirements under IVDR

2026-01-27, 12:30 PM

Session Details:

PANEL DISCUSSION Building and scaling clinical affairs teams with the right expertise

2026-01-27, 2:30 PM

Session Details:

Q&A session: lessons learned from former Notified Body expert

2026-01-27, 5:00 PM

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Next speaker
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Dr. Arne Böhling
Global Clinical Affairs Director, Mölnlycke Healthcare

Dr. Arne Böhling is a senior clinical research leader with over one and half decade of experience in the healthcare and medical device industries. Currently Global Clinical Affairs Director at Mölnlycke Health Care, he has previously held leadership roles at Essity and proderm, where he directed global clinical research programs and contributed to the commercial success of innovative healthcare solutions. Dr. Böhling has extensive experience managing cross-functional teams, integrating clinical evidence into product development and market strategies, and aligning research with business objectives. He has served as chairman of a human subject research board and is a frequent speaker at international conferences, sharing insights on clinical study design, dermatological research, and the intersection of science and business in healthcare innovation.

Session Details:

Aligning clinical trial execution with business objectives

2026-01-28, 11:30 AM

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Dr. Manuela Stauss-Grabo
Senior Vice President and Head of Clinical Research, Fresenius Medical Care

Session Details:

Adapting trial designs to global market realities

2026-01-27, 10:00 AM

Session Details:

PANEL DISCUSSION Getting innovative devices approved in today’s regulatory landscape

2026-01-27, 3:00 PM

View In Agenda
Next speaker
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Richard Holborow
Global Head Clinical Compliance, BSI

Richard Holborow BSc (Hons) MSCST RCCP

Richard Holborow is the Head of Clinical Compliance at BSI. Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specialising in implantable cardiac devices and electrophysiology. Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organisation. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

Session Details:

PANEL DISCUSSION Meeting Notified Body expectations for clinical data in 2026

2026-01-27, 11:30 AM

Session Details:

Navigating clinical compliance challenges in emerging medical device technologies

2026-01-27, 2:00 PM

View In Agenda
Next speaker
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Dr. Tonia Jeiter
Associate Director Clinical R&D, Alcon & Former Clinical Team Lead, TÜV SÜD

Session Details:

PANEL DISCUSSION Meeting Notified Body expectations for clinical data in 2026

2026-01-27, 11:30 AM

Session Details:

Q&A session: lessons learned from former Notified Body expert

2026-01-27, 5:00 PM

View In Agenda
Next speaker
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Dr. Ulrich Nitsche
Global Director Clinical Centre of Excellence, TÜV SÜD

Session Details:

PANEL DISCUSSION Meeting Notified Body expectations for clinical data in 2026

2026-01-27, 11:30 AM

View In Agenda
Next speaker
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Karny Ilan
Co-Founder and CEO, Feminai

Session Details:

Generating the right evidence for AI-driven and predictive devices

2026-01-28, 9:30 AM

Session Details:

PANEL DISCUSSION Building and scaling clinical affairs teams with the right expertise

2026-01-27, 2:30 PM

View In Agenda
Next speaker
Back
Jens Pfannkuche
Director Regulatory Affairs, Penumbra

Session Details:

PANEL DISCUSSION Getting innovative devices approved in today’s regulatory landscape

2026-01-27, 3:00 PM

Session Details:

Bridging legacy IVD devices to IVDR clinical expectations

2026-01-27, 4:00 PM

View In Agenda
Next speaker
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Autumn Lang, PhD, RAC
Director Clinical Affairs, deepeye Medical

I have spent over 25 years in the medical device industry focusing on two core challenges: identifying the essential clinical evidence needed for an innovative device and strategizing the most efficient way to acquire it. My work is driven by the conviction that innovation thrives when we eliminate excess overhead and are willing to cross geographic borders to get the evidence we need.

Session Details:

Choosing the right partner for clinical success

2026-01-27, 12:30 PM

View In Agenda
Next speaker
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Maike Hiller
Clinical Development Lead, Philips

Session Details:

Simplifying PMCF with realistic and actionable strategies

2026-01-27, 4:00 PM

View In Agenda
Next speaker
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Katrin Simioni
Deputy Head Clinical Operations, AO Foundation

Session Details:

PANEL DISCUSSION Managing global regulatory divergence to enable faster approvals

2026-01-28, 10:30 AM

Session Details:

Modernising global data collection for observational and registry studies

2026-01-28, 2:30 PM

View In Agenda
Next speaker
Back
Dr Stephan Theinert
Head Clinical Development, Eyesense

Session Details:

Leveraging retrospective data for CE marking and robust clinical evaluation under MDR

2026-01-27, 3:00 PM

Session Details:

ROUNDTABLES PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2026-01-28, 3:30 PM

Session Details:

PANEL DISCUSSION Building and scaling clinical affairs teams with the right expertise

2026-01-27, 2:30 PM

View In Agenda
Next speaker
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Talia Milosevic
Director, Clinical Safety, Surgical Structural Heart, Edwards Lifesciences

Session Details:

ROUNDTABLES PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2026-01-28, 3:30 PM

View In Agenda
Next speaker
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Sarah Johnson
VP, Head of Clinical Affairs, QIAGEN

Session Details:

Navigating the new competent authority application process for companion diagnostics under IVDR

2026-01-27, 2:30 PM

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Anna Mayer
Clinical Auditor, TÜV SÜD

Anna has more than 5 years experience in Clinical Investigations with Medical Device and over 8 years with Notified Body Certification of Medical Device Manufacturer.

Session Details:

ROUNDTABLES PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2026-01-28, 3:30 PM

View In Agenda
Next speaker
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Dr. Philipp Schatz
Global Regulatory Leader – IVD, Bayer 12:00

Session Details:

CASE STUDY Validating digital diagnostics and complying with both IVDR and the AI Act

2026-01-27, 11:30 AM

View In Agenda
Next speaker
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Mojca Valjavec
Regulatory Affairs MD & IVD, Biocartis

Session Details:

Coordinating IVD and therapeutic evidence in combined clinical trials

2026-01-27, 2:00 PM

View In Agenda
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Advisory Board

Select a member to learn more

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Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

 

Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

 

Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

 

Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

 

Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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Dr Alison McMorn
PH.D – VP, CLINICAL DEVELOPMENT, AMO PHARMA LTD

Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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Behtash Bahador
Director, Health Literacy, CISCRP

Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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Kathleen Cohen
Vice President, Clinical Development, Marinus Pharmaceuticals

Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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Aditya Kotta
Head of Business Development, Novotech

Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv.

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Martin Rodriguez
Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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Hochstrasse 3 Munich 81669 Germany

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  • 150+ attendees each year
  • 80% attendees C-suite level

 

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+44 204540 7786

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+44 204540 7786

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

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