A Special Thanks to Our Sponsors

Day One Agenda
Thursday, March 14

8:00  REGISTRATION & WELCOME COFFEE

8:50   CHAIRPERSON’S OPENING REMARKS
Elena Kyria, Founder & CEO
ELEMED

9:00   OPENING ICE BREAKER: SHARING INSIGHT INTO REGULATORY AFFAIRS DATA DIGITIZATION OPPORTUNITIES & CHALLENGES
This interactive ice breaker opens the event with a networking activity enabling participants to meet other delegates and build contacts, all while sharing 3 key considerations in either the established, ongoing, or considered transition to the use of a regulatory information management system.

9:30   SHORT, MID & LONG-TERM CONSIDERATIONS IN THE ONGOING IMPLEMENTATION OF A SUSTAINABLE EUROPEAN REGULATORY FRAMEWORK
Part 1 – SHORT-TERM: RECENT MDR DEVELOPMENTS & CURRENT STATUS
• Focus on MDCG 2022-14 & actual efficiency in practice
• MDCG 2022-18 & ability to keep legacy devices on the market
• 2023 amendment & impact on the entire ecosystem
Frank Matzek, VP Regulatory & Governmental Affairs
BIOTRONIK

10:15   COFFEE & NETWORKING BREAK

10:45 Part 2 – PANEL DISCUSSION – MID & LONG-TERM: FRAMEWORK REVIEW & OUTLOOK INTO MDR v.2
• EU Commission audit of the regulatory system
• Shedding light on expected points of improvement
• Ongoing gray areas & challenges to remediate
• Vision of the future of MDR & next steps
Frank Matzek, BIOTRONIK
Erik Vollebregt, AXON LAWYERS

11:30   PANEL DISCUSSION – BUILDING RESILIENCE IN THE REGULATORY ROLE TO WITHSTAND CONTINUOUS CHANGES
• Regulatory system maintenance considerations:
         » Increasingly large amounts of rules
         » Lack of predictability
• Defining flexibility & adjustment in regulatory strategies
• Solidifying swift regulatory intelligence practices
• Team management strategies towards “change-readiness”
Sophie Vaillot, BOSTON SCIENTIFIC
Carine Cochereau, INTEGRA LIFE SCIENCES
Glenda Marsh, JOHNSON & JOHNSON

12:15   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:15  MDR TRANSITION CHALLENGES & PRACTICAL SOLUTIONS: FOCUS ON QUALITY SYSTEMS AUDITS & REGULATORY SUBMISSIONS
Preparing for an audit or submission in the MDR framework remains a challenging task for manufacturers, and compliance teams face heightened complexities with different interpretations in a growing EU regulatory system. Participants in this hands-on, interactive session gain insight into applying lessons from other organizations, optimize the use of MDCG guidance documents and explore actionable solutions to ensure long standing regulatory compliance.
Christian Podolak, VP QM/RA
GS CORPULS
Jenni Ritter, Director Regulatory Affairs
GS CORPULS

2:45   SPECIFIC CASE OF A MEDICAL TECHNOLOGY INCLUDING DEVICES CE-MARKED BY OTHER MANUFACTURERS: FOCUS ON OPTIMIZING THE QA/RA STRATEGY
• Clarifying the rationale for partnering with other medtech manufacturers
• Identifying the best regulatory pathway & pros/cons in:
         » Distributing a device already CE-marked
         » Becoming the legal manufacturer of others’ devices
• Definition of the quality agreements, roles & responsibilities
• Practical execution of the strategy & lessons learned
Luisa Mella, Director, Global Quality/EMEA Regulatory
ASENSUS SURGICAL

3:30   COFFEE & NETWORKING BREAK

4:00   ANALYSIS OF GAINED EXPERIENCE TO FURTHER REFINE PRRC RESPONSIBILITIES
• Ensuring the role has been correctly defined:
         » Article 15.1 exact scope of application
         » Basic requirements & expectations
         » Internal vs. outsourced PRRC
• Limits to an in-house dual regulatory & PRRC role
• Knowledge gained from interactions with NBs & CAs
• Refining the role for improved efficiency & compliance
Elem Ayne, President
TEAM-PRRC

4:45   REVOLVING ROUNDTABLES: FINE-TUNING PARTNERSHIPS WITH ECONOMIC OPERATORS TO REACH COLLABORATIVE EXCELLENCE
With experience gained since the release of the MDR in 2017, regulatory teams can now raise the bar in ensuring optimal collaborations with economic operators. While the industry can better define expectations, it is also crucial to take into consideration the position and perspective of the importer, distributor, and authorized representative in order to structure a partnership that will guarantee mutual satisfaction. In this interactive session, participants will break into smaller groups to discuss challenges and exchange solutions with 30 min spent with each type of operator.
GROUP 1 – IMPORTER &/OR DISTRIBUTOR
Imene Benachour, Business Development Manager
CELLULOPLAST PRODUCTION
GROUP 2 – AUTHORIZED REPRESENTATIVE
Kathrin Steiner, Quality Manager
EC CERTIFICATION SERVICE

5:45   Closing Remarks & End of Day 1

6:30   CONTINUED NETWORKING: FACILITATED GROUP DINNER
Q1 Productions will arrange a dinner reservation at local restaurants close to the conference hotel for participants interested in joining a group of fellow participants for dinner. Kindly note that while Q1 Productions is happy to facilitate group dinners, expenses are to be covered by each participant individually.

Day Two Agenda
Friday, March 15

8:00   REGISTRATION & WELCOME COFFEE

8:20   CHAIRPERSON’S OPENING REMARKS

8:30  LESSONS APPLICABLE TO CLINICAL AFFAIRS IN ACHIEVING MDR CERTIFICATION FOR A LEGACY DEVICE
• Practical insight into the clinical data gap assessment
• Developing a thorough clinical evaluation plan
• Communication with authorities pre & post submission
• Potential course-correction & lessons from the initial exchange
• Importance of the PMCF plan rationale in obtaining certification
Norbert Clemens, Director Clinical Trial Management EMEA
FORMERLY WITH HOYA SURGICAL OPTICS

9:15    NOTIFIED BODY INTERVIEW: CLARIFICATION OF COMMON REGULATORY MISCONCEPTIONS
Regulatory teams raise increasingly precise interrogations pertinent to competent authority and notified body processes for ongoing submission management, as well as expectations for manufacturers to accurately prioritize final steps in the time left to reach full conformity. Participants are given the unique opportunity to address questions to competent authorities and notified bodies through interview formats, providing clear and definite answers necessary to carve out timely compliance action plans.
INTERVIEWER:
Bassil Akra, CEO
AKRA TEAM
INTERVIEWEES:
Daniele Bollati, Product Conformity Assessment/Medical Devices Expert
IMQ
Marianna Mastroroberto, Internal Clinical Expert
KIWA CERMET ITALIA
Itoro Udofia, Director MHS – UK
TÜV SÜD PRODUCT SERVICE

10:00   COFFEE & NETWORKING BREAK

10:30   DEEP DIVE INTO MDR CERTIFICATION STORIES & LEARNING FROM PEERS’ EXPERIENCE
• Making use of additional time to transition
• Portfolio rationalization & mapping the route to MDR
• Focus on technical file preparation & upgrading
• Posing qualified decisions & developing rationales
• Interactions with NB for file review & audits
• Encountered pitfalls & implemented solutions
Bassil Akra, CEO
AKRA TEAM

11:15   EFFICIENTLY RECONCILING MEMBER STATE & EUDAMED REQUIREMENTS
• Identifying commonalities in requirements:
• Structuring a comprehensive & flexible strategy
• Outlook into next steps for EUDAMED
• Upcoming member state specific legislation
Marina Madokoro, Regulatory Affairs Manager, UDI EMEA
JOHNSON & JOHNSON MEDTECH

12:00   LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES

1:00   GLOBAL ROLL-OUT POST-MDR CERTIFICATION: FOCUS ON LABELING & GLOBAL REGISTRATIONS
• Mapping country-specific needs for a submission/notification
• Labeling materials review & comprehensively planning updates
• Opportunities & challenges with electronic IFU integration
• Developing a thorough transition plan & timeline
• Supply chain consideration for product provision
• Impact of the EU MDR amendment on the global roll-out
Dimitriya Bozukova, Senior Manager, Clinical Evaluation
TERUMO EUROPE

1:45   PRACTICAL APPROACH TO ELUCIDATING AI ACT GRAY AREAS
• Focus on AI Act & MDR areas of convergence & divergence
• AI Act & innovation: Challenges & opportunities
• Best practices in preparing for compliance
Erik Vollebregt, Partner
AXON LAWYERS

2:30   SPOTLIGHT ON THE EUROPEAN HEALTH DATA SPACE’S IMPACT ON THE INDUSTRY
• Review of the EHDS purpose & integration status
• EHDS & GDPR: Areas of convergence & dissonance
• Regulatory team responsibilities & adjustments for compliance
• Technical aspects of an EHDS strategy implementation
Leo Hovestadt, Director Governmental Affairs EU
ELEKTA

3:15   Closing Remarks & Conference Conclusion