*Central US Time
*Central US Time
Florianne Torset-Bonfillou
Senior Regulatory International Project Manager
GMED NORTH AMERICA
Balazs Bozsik
Technical Director – Medical Audit
SGS NORTH AMERICA
Adam Black
Regulatory Affairs Manager
ULTRADENTS PRODUCTS
Erik Vollebregt
Partner
AXON LAWYERS
Vladimir Murovec
Counsel
OSBORNE CLARKE
Alex Denoon
Partner
BRISTOWS LLC
Deep Pal
Global Vice President Regulatory Affairs
CARDINAL HEALTH
Tania Pearson
Regulatory Systems Director
MEDTRONIC
Deepthi Badrinath
Regulatory Affairs Manager
PLANET INNOVATION
Jim Talbot
VP of Regulatory Affairs & Quality Assurance
QAPEL MEDICAL INC
Eleonora Chakraborty
Associate Director, Regulatory Affairs
ABBOTT
Becky Aldhizer
Director, Regulatory Operations Product Labeling
STERIS
Adam Cargill
Director, QARACA
MEDIVIEW
Allen Curreri
Manager, Regulatory Affairs – Medical Writing
STERIS
Roger Peterson
Senior Manager, Global Labeling, Regulatory
ARTHREX INC
9:00 ZOOM SIGN-ON & VIRTUAL COFFEE
9:25 VIDEO PROGRAM WELCOME & OPENING REMARKS
9:30 DISSECTING THE AMENDMENT TO MDR COMPLIANCE DATES & ARTICLE 120
• Review of extended timelines per device risk class
• Ensuring NB surveillance by September 2024
• Repeal of the sell-off period for legacy devices
• Defining qualifications for a valid certification per article 120
• Appropriately using the additional time for compliance
Vladimir Murovec, Counsel
OSBORNE CLARKE
10:15 NON-LEGISLATIVE MEASURES FOR MDR ROLL-OUT UNDER MDCG 2022–14 & NEXT STEPS FOR THE MDR
• Overview of non-legislative measures proposed by the MDCG to expedite MDR roll-out
• Expected effect of the respective measures & review of actual efficiency in practice
• Direct impact of the MDCG 2022-14 measures on manufacturers
• Current review of the MDR by the Commission & forecast of next steps
Erik Vollebregt, Partner
AXON LAWYERS
11:00 NB INTERVIEW: GAINING CLARITY INTO COMMON AREAS OF CHALLENGE
With the recent amendment of MDR compliance dates, come many questions from manufacturers in regards to the management of new timelines. Focusing on areas such as review timeframes to expect or overall clinical data acceptability, as well as offering insight into differing perspectives from one body to the next, professionals are given the unique opportunity to address questions to notified body speakers through this session, to receive direct and transparent feedback, ultimately providing clarity into concerns of critical importance.
INTERVIEWER:
Adam Cargill, MEDIVIEW
INTERVIEWEES:
Florianne Torset-Bonfillou, GMED NORTH AMERICA
Balazs Bozsik, SGS NORTH AMERICA
Gretchen Adams, DEKRA CERTIFICATION INC
11:45 VIRTUAL PROGRAM BREAK
12:45 NOTIFIED BODY GROUP DISCUSSIONS
In order to dive deeper in the understanding and application of the regulation, participants will break into smaller groups to engage with notified body speakers as well as peers, enabling an exclusive and highly acute learning experience.
Florianne Torset-Bonfillou, GMED NORTH AMERICA
Balazs Bozsik, SGS NORTH AMERICA
1:30 CASE STUDY: GAINING EFFICIENCIES THROUGH PRACTICAL LEARNINGS FROM PEERS IN SUCCESSFUL MDR CERTIFICATIONS
• Mapping out a comprehensive regulatory transition
• Achieving necessary quality & quantity of clinical data
• Interaction & communication with notified bodies
• Encountered pitfalls & implemented solutions
Adam Black, Regulatory Affairs Manager
ULTRADENTS PRODUCTS
2:15 VIRTUAL COFFEE BREAK
2:45 WORKSHOP: MASTERING THE DEVELOPMENT OF A COMPLIANT EU MDR PLAN FOR LEGACY DEVICES
• Key elements & procedures to include in the transition plan
• Establishing a timeline & resource allocation
• Conducting a thorough clinical data gap assessment
• Proper updating & development of the technical file
• Proactive approach to communicating with NBs
Deepthi Badrinath, Regulatory Affairs Manager
PLANET INNOVATION
3:30 SUCCESSFULLY BALANCING PROJECTS WITHIN TEAMS IN REGARDS TO EU MDR IMPLEMENTATION
• Outlining & onboarding the ideal regulatory team
• Best practices in dividing tasks for manageable benchmarks
• Prioritizing tasks to enable a healthy transition pace
• Ensuring teams are adhering to established timelines
Deep Pal, Global Vice President Regulatory Affairs
CARDINAL HEALTH
4:15 Closing Remarks & End of Day 1
8:00 ZOOM SIGN-ON & VIRTUAL COFFEE
8:20 VIDEO PROGRAM WELCOME & OPENING REMARKS
8:30 SHEDDING LIGHT ON THE EVOLVING UK REGULATORY FRAMEWORK
• Current status & expected timeline for release
• Potential for alignments with EU MDR
• Update of labeling requirements for the UK market
• Step by step approach to UKCA achievement
Alex Denoon, Partner
BRISTOWS LLC
9:15 MASTERING THE USE OF EUDAMED ALBEIT MISSING MODULES
• Current status of implementation & next steps
• Leveraging the use of existing EUDAMED modules
• Developing a strategy for upcoming modules
• Remaining abreast of & adapting to continuous changes
Tania Pearson, Regulatory Systems Director
MEDTRONIC
10:00 VIRTUAL COFFEE BREAK
10:30 PRACTICAL APPROACH TO COMPLYING WITH EUROPEAN UDI RULES
• Ensuring a sound approach to publishing UDI data in EUDAMED
• Review & comparison EU UDI ruling vs international markets
• Carving a flexible strategy to sustain potential updates
Becky Aldhizer, Director, Regulatory Operations Product Labeling
STERIS
11:15 FOCUS ON LABELING IN THE EU MARKET
• Identifying MDR provisions directly impacting labels & IFUs
• Updates to symbol requirements for EU compliance
• Ensuring a sound approach to the distribution channel
Roger Peterson, Senior Manager, Global Labeling, Regulatory
ARTHREX INC
12:00 LUNCH BREAK
1:00 UPHOLDING A SUCCESSFUL POST MARKET SURVEILLANCE PROGRAM
• Common areas of hurdle with EU MDR requirements
• Best practices in collecting data for QMS
• Utilizing other data sources to gather information
• Mapping critical benchmarks & timelines for reporting
Jim Talbot, VP of Regulatory Affairs & Quality Assurance
QAPEL MEDICAL INC
1:45 CREATING A PROACTIVE POST MARKET CLINICAL FOLLOW UP PROGRAM
• Comparing methods to collect effective data for long-term clinical performance:
» Use of surveys
» Opportunities with registries
» Literature reviews
• Proper definition of sufficient clinical data in relation to the device
• Maintaining an ongoing network with clinical experts & KOLS
• Practical tips in executing a comprehensive strategy
Allen Curreri, Manager, Regulatory Affairs – Medical Writing
STERIS
2:30 VIRTUAL COFFEE BREAK
3:00 CONTINUOUS IMPACT OF MDR OUTSIDE OF MEMBER STATE MARKETS
• MDR-related legislation in EU non-member states
• MDR extension & replication in EU non-member states
• Impact & position of mutual recognition markets
Eleonora Chakraborty, Associate Director, Regulatory Affairs
ABBOTT
3:45 SMALL GROUP DISCUSSION: EXCHANGING & BUILDING KNOWLEDGE IN EU COMPLIANCE SPECIFICS FOR DEVICES INCLUDING SOFTWARE OR AI
With the outstanding influx of software and AI in the medical device industry, existing and upcoming European rules must be carefully understood by regulatory affairs professionals to ultimately ensure compliance.
Deep Pal, Global Vice President Regulatory Affairs
CARDINAL HEALTH
4:30 Closing Remarks & Conference Conclusion
Director, Professional Relations, 3M HEALTHCARE
Senior Manager, Professional Education, ACCLARENT
Global Director of Training, ACUFOCUS
Director, Professional Education, APOLLO ENDOSURGERY
Renal Clinical Education Manager, BAXTER
Manager, Physician Training, BD
Physician Training Specialist, BD
Manager, Surgical Education, BD
Global Endovascular Training Manager, BOLTON MEDICAL
Medical Education Manager, BOSTON SCIENTIFIC
Medical Education Manager, CARDIOVASCULAR SYSTEMS
Manager, Clinical Education and Training, CORDIS
Mgr, Advanced Imaging and Training, EDWARDS LIFESCIENCES
Dir, Sales Training & Therapy Dev, EDWARDS LIFESCIENCES
Clinical Manager, Learning and Development, HOLOGIC
Technical Training Manager, INOVA DIAGNOSTICS
Manager, Professional Affair, INTEGRA LIFESCIENCES
Senior Director, Professional Education, JANSSEN
Clinical Training Manager, MEDTRONIC
Medical Education Manager, MEDTRONIC
Head of Strategic Planning, MIDMARK
Vice President, Customer Care & Midmark India, MIDMARK
Sr. Director of Professional Education, ORTHALIGN, INC.
Director, Professional & Clinical Services, OTTOBOCK
Sr Manager, Field Applications, Clinical Education, PHILIPS
Senior Manager, Clinical Education, PHILIPS
Senior Medical Education Specialist, SEA SPINE
Director, Professional Affairs, SMITH & NEPHEW
Dir, Product Marketing and Professional Education, SONENDO
Sr. Manager, Professional Education, SONENDO
Dir of Clinical Affairs and Med Education, SYMMETRY SURGICAL
Dir, Professional Dev, Clinical & Medical Affairs, TELEFLEX
Clinical Specialist, VARIAN MEDICAL SYSTEMS
Director of Education, VATECH AMERICA
And many more!
Executives working within the medical device industry that will find this program of greatest relevance are those currently working in regulatory affairs functions with a focus on EU MDR compliance.Job titles of those executives that will find this program to be most applicable to the job function include:
• Regulatory Affairs
• Regulatory & Clinical
• Regulatory & Quality Affairs
• EU MDR Program Management
