DAY ONE | TUESDAY, JULY 16
7:45 REGISTRATION & WELCOME COFFEE
8:30 CHAIRPERSON’S OPENING REMARKS
8:40 ICE-BREAKER: BENCHMARKING EU MDR IMPLEMENTATION WITH INDUSTRY PEERS
Regulatory professionals making EU MDR implementation decisions within an organization have difficulty determining how the industry is approaching these changes as a whole. With a multitude of grey areas and ample room for interpretation of regulatory requirements, benchmarking with industry peers is a hugely beneficial exercise in understanding how far along a company is in its implementation efforts. As an opening ice-breaker, participants will engage with other regulatory professionals to discuss how close organizations are to full implementation and how companies expect to achieve compliance before the timeline comes to a close.
Kimberly Thomas-Pollei, Senior Manager Clinical Evidence and Risk Management, BOSTON SCIENTIFIC
9:10 REGULATION COUNTDOWN: BENCHMARKING PREPAREDNESS AGAINST REMAINING MDR TRANSITION PERIOD
As of March 2019, there will be less than a year remaining in the EU MDR transition period, and manufacturers must review current areas of preparedness, both internally, as well as against external timelines and benchmarks such as notified body certification, readiness of the EUDAMED database, as well as any potential implementing acts which may be released. Setting the tone for the meeting, this opening presentation will provide a high level review of the remaining implementation time, with a focus on how organizations can best prioritize areas of compliance in order to align certificates and businesses for the May 2020 deadline.
- Current status of notified body certification
- Insight into EUDAMED database readiness
- Review of legacy certificate expiration
- Perspective on implementing acts
Erik Vollebregt, Partner, AXON LAWYERS
9:55 COFFEE AND NETWORKING BREAK
10:25 CASE STUDY: EVALUATION OF NB PARTNERSHIPS & COMMUNICATION STRATEGIES TO ENSURE SUCCESS
As regulatory experts work to determine how to realign technical files, documentation and practices under the MDR, clear and open communication between the medical device industry and notified bodies is an essential part of implementing compliant practices. When these lines of communication break down, it can pose a significant financial risk to a company’s product line, but transitioning from one notified body to another is a costly and time consuming process. Insight into how one company established key communication strategies with its notified body will provide delegates with an example of how this daunting process can be turned into an opportunity for growth and renewed security.
- Benchmarking current NB partnerships
- Productive communication with NBs
- Submission strategies and documentation
Cory Marsh, Manager, Regulatory Operations, MERIT MEDICAL
11:10 IDENTIFICATION AND ELIMINATION OF REMAINING GAPS IN EU MDR COMPLIANCE: MULTI-PART LEARNING MODULE
With less than a year remaining in the EU MDR timeline, medical device companies at every stage of implementation readiness must conduct regular internal audits to determine the areas where compliance standards still require an update. A guided example of this preemptive gap assessment will help audience members understand how to mitigate instances of non-compliance that could delay or eliminate a product’s chances of certification. With a focus on utilizing the remaining MDR timeline, participants will then work in small groups with representatives from other similarly prepared organizations to gain an understanding on how to assess and abate these noncompliance issues and work to ensure a swift certification process.
MODULE ONE: CASE STUDY: IMPACTED DEPARTMENTS & EU MDR GAP ASSESSMENT
Mira Leiwant, VP, Global Regulatory Affairs, BTG PLC
Amy McKinney, Sr. Manager, Regulatory Affairs, BTG PLC
11:40 MODULE TWO: BREAKOUT GROUPS BASED ON LEVEL OF IMPLEMENTATION DEVELOPMENT
GROUP 1: Companies with near-complete implementation
Mira Leiwant, Vice President, Global Regulatory Affairs, BTG PLC
GROUP 2: Mid-way implementation assessment
Amy McKinney, Sr. Manager, Regulatory Affairs, BTG PLC
GROUP 3: Gap Assessment in the beginning stages
Adam Grimshaw, Corporate EU MDR Risk Mgmt Lead, HILL-ROM
12:25 LUNCHEON FOR ALL ATTENDEES
1:30 PANEL: ENSURING CERTIFICATION IN THE NOTIFIED BODY BOTTLENECK
As the implementation deadline draws nearer, the narrow field and finite resources of notified bodies is a growing concern among regulatory professionals. The EU MDR has led to a drastic spike in demand for device certification while the scope and availably of notified bodies is more limited than ever. Delayed certification can pose a serious risk to a product’s viability, as well as the medical device company as a whole. Regulatory affairs experts must do everything they can to prepare their devices for certification and ensure a streamlined approval process. This panel will deliver a variety of perspectives from medical device companies and notified bodies alike on what strategies can best be employed to meet and overcome the upcoming certification bottleneck.
Establishing line of communication with a notified body
Determining implementation gaps with internal audits
Using the remaining timeline to close gaps in compliance
MODERATOR: Tanya Klaslo, BECTON DICKINSON
PANELISTS: Dona Occhipinti, HILL-ROM
Eric Henry, KING & SPALDING
Patrick Biggerstaff, W.L. GORE
2:15 MULTI-PART CASE STUDY: PRIORITIZING PRODUCTS FOR SUCCESS IN THE RECERTIFICATION PROCESS
Under the EU MDR, companies of all sizes are making critical portfolio decisions when considering re-certification processes, costs associated with compliance and aligning company goals against the cost of compliance. New regulations surrounding classification and clinical evidence have led to teams prioritizing which devices are best suited for certification and which will need to be pulled from the market completely. Several companies will join to share perspective of what a good blend of prioritization tactics looks like and how to determine what mix will work best for a company’s unique product line.
- Analysis of compliance cost vs. revenue
- Marketplace product interaction
- Market surveillance and timely submissions
CASE STUDY 1: LARGE CORPORATION PERSPECTIVE
Karen Leigh, International Regulatory Manager, 3M
2:45 COFFEE AND NETWORKING BREAK
3:15 CASE STUDY 2: SMALL TO MID-SIZED CORPORATE PERSPECTIVE
Evangeline Loh, Global Regulatory Manager, EMERGO BY UL
3:45 CASE STUDY 3
Patrick Biggerstaff, Regulatory Affairs Associate, W.L. GORE
4:15 PANEL: ALIGNING FOR MDR COMPLIANCE WITHIN THE CONTEXT OF BREXIT UNCERTAINTY
Uncertainty surrounding the United Kingdom’s legal separation from the European Union continues to cause considerable concern for corporations currently operating in both the United Kingdom as well as throughout the European Union. Beyond trade and customs issues, manufacturers face concerns surrounding product certifications processed in the United Kingdom through local Notified Bodies, as well as the access for devices certified outside of the UK in the post-Brexit scenario. While definitive guidance is not yet available, a panel of varied stakeholders will share perspectives on potential regulatory frameworks, as well as preparations being made by forward thinking Notified Bodies and manufacturers.
- Provisional legislation currently in place
- Grandfathering of existing authorizations
- Timelines for new product certifications
MODERATOR: Tracy Eberly, FANG CONSULTING
PANELISTS: Roger Peterson, ARTHREX
Mira Leiwant, BTG PLC
Todd E. Moorman, BSI
5:00 END OF DAY ONE CONFERENCE
6:30 CONTINUED NETWORKING: FACILITATED GROUP DINNERS
*With the immense value in peer-to-peer interaction and experience sharing, we wish to provide attendees with an opportunity to continue networking after the first day of the conference. Q1 Productions will arrange dinner reservations at local restaurants close to the conference hotel for those interested in joining a group of fellow participants for dinner on July 16th. Please note that dinner expenses must be covered by each participant individually.