Cambridge Healthtech Institute’s Inaugural

Medical Device Clinical Trial Operations and Regulations

Navigating Regulations and Operational Challenges for Quality Medical Device Clinical Trials

February 19-20, 2020

The medical device industry comes with its own set of unique challenges when it comes to clinical trials, especially in light of the new medical device regulation coming out of the EU. CHI's Inaugural Medical Device Clinical Trial Operations and Regulations conference will offer insight into navigating this new regulation ahead of the May 2020 deadline, as well as insights into pre- and post-market studies. The conference will also take a deep dive into risk-based monitoring for device trials and the impact of ICH E6 R2.

Stay on and attend Part 2 (Thurs-Fri): Implementing Risk-Based Monitoring (Part 2)

Final Agenda

Tuesday, February 18

9:00 am - 7:15 pm Registration Open (Regency Rotunda)

2:00 - 5:00 pm User Group Meetings

2:00 - 5:00 pm The NEW SCOPE China Clinical Development Partnering Forum and The NEW SCOPE Scientific Symposium*

*Separate registration required. Must be a Best Value registered attendee.

5:00 - 6:20 pm Evening Kick-Off Plenary Keynote and Participant Engagement Awards (Regency Ballroom S)

6:20 - 7:30 pm SCOPE’s Kick-Off Networking Happy Hour (Upper Pool Deck, 4th Floor)

(Co-Sponsorship Opportunities Available)

7:30 pm Close of Day

Wednesday, February 19

7:15 am Registration Open (Regency Rotunda) and Morning Coffee (Regency Ballroom S Foyer)

8:15 Morning Opening Plenary Keynotes with Light Refreshments (Regency Ballroom Sprovided by Clinical_Ink_NoTagline

9:40 Grand Opening Coffee Break in the Exhibit Hall (Windermere Ballroom)Highthink_Med

Celebration 12-13

10:40 Chairperson’s Remarks

Jane M. Jacob, PhD, CCRP, Vice President, Research and Clinical Affairs, Orthofix, Inc.

10:45 NEW: The Interplay Between the MDR and Data Protection Law

van_der_Heijden_CecileCécile van der Heijden, LLM, Attorney-at-law, Axon Lawyers

The MDR explicitly requires adherence to data protection law. As a consequence thereof, medical devices companies are obliged to take the GDPR into account when applying the MDR. This presentation will focus on what the interplay between MDR and GDPR means in practice, with a focus on the impact the GDPR has on the device design requirements, incident reporting and the regime applicable to clinical investigations under the MDR.

11:30 NEW: INTERACTIVE PANEL: Navigating the EU MDR and Other Regulations

van_der_Heijden_CecileModerator: Cécile van der Heijden, LLM, Attorney-at-law, Axon Lawyers


Bolton_JenniferJennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific Corporation

Jacob_JaneJane M. Jacob, PhD, CCRP, Vice President, Research and Clinical Affairs, Orthofix, Inc.

This panel will discuss strategies in finalizing device companies’ preparedness for the impending European Medical Device Regulation, and how this new regulation will – or will not – affect larger changes around the FDA’s regulations. We'll discuss the role of clinical data management in meeting these regulations.

12:15 pm Enjoy Lunch on Your Own

1:20 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)Abond


2:15 Chairperson’s Remarks

Larry Veal, Vice President, North American Business Development, NAMSA

2:20 Pre- and Post-Market Studies: Addressing Challenges Unique to Medical Devices

Jacob_JaneJane M. Jacob, PhD, CCRP, Vice President, Research and Clinical Affairs, Orthofix, Inc.

Medical device studies, either pre- or post-market, are unique compared with drug studies. Knowing what those similarities and differences are, and how to tackle them, is the key to running successful studies. In this presentation, I will discuss some of the strategies I have found that work for both IDE and post-market studies in terms of site identification, qualification, start-up and follow-up, and suggest different approaches one can take to (hopefully) achieve success.

2:50 Pre- and Post-Market Studies: Use of Real Word Data (RWD)

Bolton_JenniferJennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific Corporation

This presentation will outline the purpose of pre- and post-market studies and why multiple types are necessary. I will provide a comparison of requirements by study type and share how real-world data and experience (RWD/RWE) could be used in both pre- and post-market studies. This presentation will highlight a case study in embedding post-market studies in national registries.

3:20 NEW: Abbott EDC Portal, A Collaborative Platform for Sites and Sponsors to Manage Trials From Start-Up to Completion

Rocks_KrupaKrupa Rocks, Associate Director, Clinical Data Systems, Abbott Medical Devices Division

In order to successfully manage trials, both sites and sponsors require a unified, integrated platform to provide a real-time view of the status and health of studies across the different phases of trial conduct. There are several different tools available in the market today to address different needs ranging from start-up, to e-TMF, to study health dashboards but they are all disconnected and require major integration efforts. This presentation will highlight how Abbott’s new EDC Portal is aiding in addressing different operational challenges in conducting medical device pre and post market clinical trials today (site activation, securing better compliance to collect device generated data, integration with CTMS for site user account maintenance, targeted communications from the sponsor, etc.). We will also cover our plans for the introduction of Machine Learning and Cognitive Services components to achieve further automation and efficiencies in reaching remote sites in different geographies especially for post market studies.

NAMSA 3:50 Missing Data in Pre- & Post-Op Market Studies: Myths, Theories and Reality

Chris Mullin, Director, Product Development Strategist, Product Development Strategy, NAMSA

With recent increased importance placed on addressing missing data in clinical trails, this covers common misconceptions of missing data, outline a framework for classifying data, and provide tips to mitigate the risks associated with absent data. Real-world examples shared to help demonstrate best practices for pre- and post-market study data.


4:20 Find Your Table and Meet Your Moderator

For more details on the Breakout Discussions:

4:25 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. To get the most out of this interactive session and format, please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and most importantly, participate in active idea sharing.

5:10 Welcome Reception in the Exhibit Hall (Windermere Ballroom)d_wise_NEW

(Co-Sponsorship Opportunities Available)

6:45 Close of Day

Thursday, February 20

7:15 am Registration Open (Regency Rotunda)

7:45 Breakfast Presentation to be Announced (Regency Ballroom T)

8:15 Session Break

Regency Ballroom V

8:20 NEW: Chairperson’s Remarks

Stephanie Clark, Director, Risk Management-Central Monitoring, Janssen R&D (J&J)

8:25 Novel Approaches to Risk-Based Monitoring for Medical Device Trials

Wetherby_MichelleMichelle Wetherby, MS, CCRP, Associate Director, Clinical Operations, Abbott Laboratories

As organizations become increasingly savvy about the implementation of risk-based monitoring, it is critical to evaluate current practice and make adjustments accordingly. This presentation will describe one organization’s evolution in the practice of risk-based monitoring.

8:55 CO-PRESENTATION: Risk-Based Monitoring at Johnson & Johnson: From Pharma to Medical Device Clinical Trials

Clark_StephanieStephanie Clark, Director, Risk Management-Central Monitoring, Janssen R&D (J&J)

Creedon_ErinErin Creedon, Associate Director, Clinical Operations, Ethicon (J&J)

RBM has been an industry buzz word for over 6 years now, but is the methodology relevant only for pharmaceutical clinical trials? Could there be benefits for medical device studies? Join to hear how J&J is leveraging its success with RBM in pharma studies on a variety of medical device trials to learn more about global regulatory support for RBM, lessons learned from pharma and early experience with mMedical device studies, and the future of RBM in the medical device space – the realization of value.

9:25 Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products

Malikova_MarinaMarina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine

A risk-based approach requires not only a strategy, but also tools to define key indicators to measure specific risks. As reference from the recent FDA’s and EMA’s recently updated guidelines, Key Risk Indicators (KRIs) and Key Quality Indicators (KQIs) metrics should focus on “what really matters”, and safety of research subjects and data integrity should be emphasized. Combination products, due to their specific nature, can increase risks while being tested in clinical trials. These critical metrics should be linked to particular processes within a development program for combination products.

Triumph_Research_Intelligence 9:55 Overcoming the Operational ‘Gap’ in RBQM

Duncan Hall, CEO, TRI

The RBQM conversation is moving from ‘why?’ to ‘how?’. The biggest challenges are operational change management and the creation of integrated strategic monitoring plans (ISMPs). ‘Critical to quality’ requires moving from routine monitoring and 100% SDV to focusing on data to be monitored, how, when and by who. Duncan shows you how to overcome these challenges, use big data analytics to do much of the monitoring ‘heavy-lifting’, and how to build ISMPs for your organization.

10:25 Coffee Break in the Exhibit Hall (Windermere Ballroom)Aris_Global_New


11:20 Chairperson’s Remarks

Glenda Guest, President, Assured of Quality Consulting & Training

11:25 INTERACTIVE PANEL: Medical Device Pathways to Market in the US and the Role of Clinical Data

Guest_GlendaModerator: Glenda Guest, President, Assured of Quality Consulting & Training

Cain_ChrisPanelists: Chris Cain, Vice President, Clinical & Regulatory Affairs, Conformal Medical, Inc.

Connolly_PattiPatti Connolly, Executive Vice President, Product Development, RenalytixAI

Chen_VictorVictor Chen, Managing Director, Clinical Trials Program, Kaiser Permanente Northern California

As EU Device Regulations become more harmonized with the FDA there is a greater focus on the role clinical trial data in the US. Following an overview of the major pathways to market and the role of clinical data for devices in the US (Premarket Notification, Premarket Approval, Humanitarian Device Exemptions) the panel will discuss trends, FDA’s new breakthrough device designation and global harmonization challenges. Audience participation will be encouraged.

12:25 pm Transition to Lunch

12:30 Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:00 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)BioTelResearch


2:00 Close of Conference

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