June 5 2025 • The Royal Sonesta Downtown Minneapolis
Building on the success of Evidence Matters 2024, a virtual Summit that attracted over 1,000 registrants from all corners of the world, DistillerSR’s Evidence Matters Summit goes On the Road in 2025. The first in-person event of the series was in San Diego. The next edition, in Minneapolis, will bring together experts and pioneers in MedTech, AI, regulatory and copyright compliance, and evidence management.
This year, we spotlight the transformative power of AI enablement combined with human-in-the-loop validation, showcasing how technology and expert oversight work together to drive efficiency, innovation, and faster time to market. Since 2021, DistillerSR’s Evidence Matters Summits have brought together global leaders in the literature review and evidence-based research community to learn, engage, and address the ever-growing challenges of synthesizing trusted evidence.
Speakers From the Following Companies
Agenda – June 5, 2025
EU MDR Clinical Evaluation Report (CER) Foundations Workshop
- Understand the Foundations of a CER: Gain a clear understanding of the purpose and regulatory context of the Clinical Evaluation Report within the MDR framework.
- Establishing Equivalence: Master the process of claiming equivalence to other devices, including the critical information and justification required to demonstrate safety & performance.
- Conducting Risk-Benefit Assessment: Master the methodology for conducting a thorough benefit-risk assessment, a crucial component of the CER.
- Leveraging Clinical Data: Explore various sources of clinical data, including literature reviews, literature search strategies, and manufacturer-generated data. Understand the Notified Body’s expectations for conducting and documenting thorough literature searches.
- Documenting Clinical Investigations: Gain insights into documenting clinical investigations, including the necessary supporting documentation and understanding the different perspectives of Notified Bodies and Competent Authorities.
- Considering Post-Market Activities: Understand the link between the CER and post-market clinical follow-up (PMCF) activities and how ongoing data collection informs CER updates.
Speakers
Bassil Akra, CEO at AKRA Team
Lucy Stone, Principal Clinical Evaluation Specialist at BSI
Chip Couch, Learning Specialist at DistillerSR
2:05 PM – 2:50 PM CST
Industry Best Practices Panel – Can AI and Automation Accelerate Regulatory Submissions, Time to Market, and MedTech Innovation?
- Understand the existing challenges and bottlenecks in MedTech regulatory submissions, time to market, and innovation processes.
- Learn how AI and automation can expedite the preparation, review, and submission of regulatory documents, potentially leading to faster approvals.
- Explore the potential challenges, risks, and ethical considerations associated with using AI in regulatory and innovation processes, such as data bias, security, and the need for human oversight.
Speakers
Angelina Lisandrelli, Director of Regulatory and Quality at RespirTech, a Philips company
Emily Metcalfe, Director, Scientific Communications at Boston Scientific
Peter O’Blenis, CEO at DistillerSR
2:50 PM – 3:00 PM CST
Break
3:00 PM – 4:00 PM CST
Notified Body Roundtable
- Understand current interpretations, expectations, and best practices directly from Notified Body representatives regarding critical aspects of the EU MDR and IVDR.
- Learn about the recurring challenges faced by manufacturers during the conformity assessment process and gain insights into how to proactively address them.
- Participate in a direct dialogue with Notified Body experts, ask specific questions relevant to your organization, and connect with peers navigating the EU regulatory landscape.
Speakers
Bassil Akra, CEO at AKRA Team
Lucy Stone, Principal Clinical Evaluation Specialist at BSI
Julien Senac, Senior Director, Medical and Health Services Americas at TÜV SÜD
Azam Korshidi, Technical File Reviewer, IVD at DEKRA
4:00 PM – 5:00 PM CST
Standardized Ontologies for Enriched Evidence Data Management
- Discover how SciBite uses standardized ontologies to automatically enrich unstructured text with consistent, machine-readable concepts, providing deeper contextual understanding for your evidence data.
- Learn how DistillerSR integrates with ontologically enriched data to streamline the systematic review process, improving search precision, filtering, and overall workflow efficiency.
- Understand how the combined power of SciBite and DistillerSR, leveraging standardized ontologies, enhances data accuracy, consistency, and facilitates the discovery of deeper insights from your evidence.
Speakers
Tom Woodcock, Technical Sales Manager at SciBite by Elsevier
Chris Wright, EVP of Operations at DistillerSR
5:00 PM – 6:00 PM CST
Networking Cocktail Hour
Speakers
Bassil Akra
CEO at AKRA Team
Lucy Stone
Chip Couch
Learning Specialist at DistillerSR
Angelina Lisandrelli
Director of Regulatory and Quality at RespirTech, a Philips company
Emily Metcalfe
Director, Scientific Communications at Boston Scientific
Peter O'Blenis
CEO at DistillerSR
Tom Woodcock
Technical Sales Manager at SciBite by Elsevier
Chris Wright
EVP of Operations at DistillerSR
Julien Senac
Senior Director, Medical and Health Services Americas at TÜV SÜD
Azam Korshidi
Technical File Reviewer,
IVD at DEKRA
EM’24 in Review
1117
registrants
580
attendees across Medical Devices/IVD, Pharmaceuticals, Public Sector, and Academia
34
Speakers from Philips, Adelphi Group, AbbVie, Stryker, PHAC, EPA, ISPOR, QuidelOrtho, OPEN Health, and CDC
4/5
Average Satisfaction Score
June 5, 2025
Evidence
Matters ⌘25
#evidencematters25
© Copyright DistillerSR Inc. 2025. All Rights Reserved.
© Copyright DistillerSR Inc. 2025. All Rights Reserved.