2020 Sessions

The COVID-19 Pandemic has caused a disruption across the entire product lifecycle in medical device and diagnostics, and has changed how products are reaching patients. Join Dr. Jijo James, Chief Medical Officer, Johnson & Johnson, Dr. Ian T. Meredith, Global CMO & Executive Vice President, Boston Scientific, Dr. Phil Febbo, Senior Vice President & Chief Medical Officer, Illumina and Davide Manissero, Chief Medical Officer & Head of Medical Affairs, Qiagen, to hear their perspectives on the Global Pandemic and the resulting impact and transformation on the medtech industry. They’ll also share perspectives on how these changes will shape the future of the entire industry.

For Business and IT

Alcon will share how they used a corporate spin-off to unify clinical operations and data environments.

For Business and IT

Our MedTech CRO Panel will discuss learnings and best practices for outsourcing clinical initiatives, including the role technology plays in enabling collaboration, transparency, and study efficiency.

For Business

Illumina will discuss how an emergency use authorization study for COVID-19 led to the adoption of electronic data capture and how this will shape the future of how they build and maintain independent clinical studies.

For Business and IT

Edwards Lifesciences will discuss the various initiatives they've undertaken to drive optimal TMF management across divisions and across regions.

For Business and IT

GE Healthcare will share best practices for measuring success with RIM, including affiliate activity, health authority approvals, and submission rejections.

For Business and IT

A successful RIM implementation requires significant planning, stakeholder involvement, and well-defined processes. In this session, Baxter will share its approach and lessons learned as they prepare and execute their RIM implementation.

For Business and IT

Alcon shares their approach as they prepare for EU MDR and best pratices for leveraging RIM to meet new regulations while driving efficiency and speed.

For Business and IT

Learn how to manage the global regulatory submission process to improve collaboration, speed approvals, and reduce administrative burden.

For Business and IT

Hear how Epredia is modernizing its technology in both quality and regulatory to enable greater collaboration and efficiency. You’ll learn how they consolidated four systems into a single quality platform and how they’re planning to unify regulatory affairs and quality assurance in the future.

For Business and IT

Learn how Biodesix assessed content management technology stacks across two companies during an M&A situation and best practices for implementing QualityDocs as the foundation of its quality transformation across the new organization.

For Business and IT

Penlon will share how they spearheaded the Ventilator Challenge UK initiative, and transformed from a paper-based to digital quality process in an effort to produce nearly 12,000 ventilators to support the fight against COVID-19 in record time. They will share how they aligned multi-national manufacturing processes and implemented Vault QMS in ten days.

For Business and IT

A leading diagnostics company will discuss current trends related to EU IVDR and how to adapt to the new clinical data requirements and accountability demands.

For Business and IT

Illumina will share how they created a clinical trial center of excellence to enable innovation and growth as a leading diagnostics company.

For Business and IT

Learn the current state of Real-World Evidence (RWE) and how to capture, generate and leverage data for pre and post market evidence decisions.

For Business

Cook Research will share how they enable global clinical research management, including real-world evidence initiatives and data driven study operations.

For Business and IT

See the new features in Vault eTMF, Vault CTMS, Vault CDMS, and Vault Payments, and how to leverage these capabilities to improve trial performance.

For Business and IT

Medtronic shares best practices for creating a more efficient medical, legal, and regulatory (MLR) review and approval process with focus on change management and measuring success.

For Business and IT

Roche Diagnostics Corporation will share best practices for implementing and utilizing DAM to better manage and deliver compliant content.

For Business

See how Vault RIM aligns registration data with global submissions and technical documentation. Get insight into the roadmap for submitting UDI data and publishing medical device submissions.

For Business and IT

Industry expert and former leader at J&J, Medtronic, and Stryker, will review the requirements of the FDA Quality System Regulation, Medical Device Reporting, and Reports of Corrections and Removals. He will also share a methodology to prepare for a flawless FDA inspection, including managing expectations before, during, and post-inspection.

For Business

Learn about new features in Vault Quality Suite that help mitigate risk and improve global compliance. See how Vault QMS can streamline business processes like post market surveillance and supplier management.

For Business and IT

Veeva will wrap up Summit with key takeaways, product direction and strategy for the future, and live Q&A with Veeva Medical Device & Diagnostics leaders.

For

For Business and IT

For Business and IT

For Business and IT

For Business and IT

For Business and IT

For Business and IT

For Business and IT

Lee Young will share best practices and strategies for transforming quality to better support new cGMP/ISO 13485 requirements.

For Business and IT

Oval Medical Technologies will share how they expanded from an R&D focused business into manufacturing and the associated transition to modernize content management to align to GMP.

For Business and IT