7TH ANNUAL EU DEVICE AND DIAGNOSTIC REGULATION CONFERENCE

SEPTEMBER 25-26, 2017 | BRUSSELS, BELGIUM | PARK INN BY RADISSON BRUSSELS AIRPORT
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DAY ONE | MONDAY, SEPTEMBER 25

7:45 REGISTRATION & WELCOME COFFEE

8:20 CHAIRPERSON’S OPENING REMARKS
Rita Peeters, Sr Director, Regulatory Affairs Policy & Intelligence EMEA, JOHNSON & JOHNSON

Luminita Tulea, Senior Manager Regulatory Affairs EMEAI, BECKMAN COULTER


8:30 OPENING ICE BREAKER: SHARING STRATEGIES FOR REGULATORY INTELLIGENCE COLLECTION

This interactive ice breaker will open the event with an opportunity for all participants to move around the conference room with the goal of meeting other delegates and engaging in discussion. Given the challenge of continuously remaining abreast of evolving rules in Europe and beyond, this small group discussion format will focus on sharing experience and strategies pertinent to collecting new regulatory requirements for Europe and beyond. Furthermore, participants in this warm-up session are also given the opportunity to build contacts with industry peers, kicking off the event networking platform.

Rainer Voelksen, OCCLUTECH

Carsten Krafcsik, TECAN

Elizabeth Gfoeller, MED-EL

Peter Schrutka-Rechtenstamm, CARL ZEISS MEDITEC

 

8:50 KEYNOTE ADDRESS: RECENT MDR-IVDR DEVELOPMENTS & TIMELINES
Since late 2011, the medical device and diagnostic industries have been closely monitoring the evolution of the new sets of regulations intended to replace the current Medical Device Directives and In Vitro Diagnostic Directives. Throughout the past 6 years, the European Commission, Parliament and Council have discussed, negotiated and debated to reach an agreement on the new regulatory frameworks aimed towards enhancing patient safety and tightened market control. While the new rules have now been published, further areas of change should be expected in the next few months. In addition, with the re-accreditation of notified bodies and final release of implementing acts in November, the industry must remain attentive to further developments impacting the implementation of the new rules.

Rita Peeters, Sr Director, Regulatory Affairs Policy & Intelligence EMEA, JOHNSON & JOHNSON

 

9:20 NOTIFIED BODY OPERATIONS MANAGEMENT & EXPECTATIONS DURING THE TRANSITION
With the overall amount of data and files that will be submitted by manufacturers during the transition time, notified bodies must have a sound plan to ensure proper and timely management of the volume of reviews. Stakeholders raise concerns in potential certification operations disruption over the transition, impacting the overall time to CE marking and European markets. As the industry currently prepares updated documentation for notified body scrutiny, regulatory affairs executives are in need of further clarification on notified body restructuring efforts, as well as expectations for product file development and submission, to ultimately secure continuous certification operations during the transition.

  • NB preparation for the MDR-IVDR impact
  • Availability of technically skilled personnel
  • Volume of data & impact on time to market
  • Clarifying expectations with new regulations

Sue Spencer, Global Service Line Director – Regulatory, UL

 

9:50 PANEL – COMPARING STRATEGIES FOR COMPLIANCE WITH DIRECTIVES & REGULATIONS DURING THE TRANSITION
As the compliance timeline spans 3 years for medical devices and 5 years for IVDs, the industry is currently challenged with abiding by the current directives all while progressively complying with the recent regulations. During the transition period of time, and considering the overlap in regulatory frameworks, manufacturing corporations will prepare new product lines for compliance with the regulations; however, products already established on the market continue to follow provisions from directives, creating a schism in regulatory strategies. Much uncertainty resides in the timeline for the actual switch from directive to regulation, and how to handle operations such as product registrations and post-market vigilance reporting during the regulatory shift.

  • Managing 2 regulatory frameworks
  • Essential requirements considerations
  • Registration concerns during the transition
  • Impact of the transition on post-market reporting
  • Perspectives on efficient use of the transition time

Bassil Akra, TÜV SÜD PRODUCT SERVICE GMBH – GERMANY

Karina Hellbert, FIEBINGER POLAK & PARTNER RECHTSANWÄLTE

Carole Robin, 3-D MATRIX EUROPE

Céline Bourguignon, JOHNSON & JOHNSON

 

10:35 COFFEE & NETWORKING BREAK

 

11:00 FIRESIDE CHAT: COMPETENT AUTHORITY PERSPECTIVE ON PREPARING FOR NEW RULES
While the industry continues to collect intelligence pertinent to the MDR and IVDR and prepare for impact, member state competent authorities also face many challenges with adapting to the new regulatory framework. Developing new processes for common operations such as product registration, clinical trial review and approval, adverse event analysis or auditing require much time and dedicated teams to ensure a steady passage into the regulations. This interview-style session will shed light on timely concerns such as competent authorities’ approach to the new rules and re-organization of internal strategies to ensure ongoing operations, as well as which market signals and trends are necessary to monitor during the transition phase.

Prodromos A. Kaplanis, Head of Medical Devices Authority
CYMDA, MINISTRY OF HEALTH – CYPRUS

Hugues Malonne, Director General, DG “Post-Authorization”
FAMHP – FEDERAL AGENCY FOR MEDICINES & HEALTH PRODUCTS, BELGIUM

Philippe Auclair, Senior Director of Regulatory Strategy & Advocacy
ABBOTT LABORATORIES

 

11:45 PANEL DISCUSSION: DETERMINING NECESSARY RESOURCES FOR THE NEW REGULATORY SETTING
Medical device and diagnostic manufacturers are currently assessing overall needs in terms of financial and human resources to achieve a smooth transition, and ensure ongoing compliance post-implementation. With the volume of changes to existing regulatory structures and in particular, the requirements for more frequent and thorough data updates for pre and post-market operations, it is pivotal that regulatory affairs teams have a sufficient number of professionals to take on all tasks. Further, the revision of regulatory strategies and inclusion of new processes involves increased budgets to carefully forecast to ensure a contained expenditure plan.

  • Human resources:
    • The need for additional personnel
    • Person responsible for regulatory compliance
  • Implementation impact on financial resources
  • Minimum necessary resources in large vs. small companies

Moderator:
Autumn Dawn Lang, VP Clinical Regulatory Affairs, CLINLOGIX EUROPE GMBH

Panelists:
Elena Kyriacou, ELEMED

Jana Grieb, MCDERMOTT WILL & EMERY

Elizabeth Gfoeller, MED-EL

Peter Schrutka-Rechtenstamm, CARL ZEISS MEDITEC

 

12:30 PRISYM ID POSTER PRESENTATION
Steve Ellison, VP of EU Sales, PRISYM ID

 

12:45 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
LUNCH TOPIC
The lunch topic enables participants to continue sharing insightful strategies over the luncheon and further engage in the event networking platform. All participants are encouraged to initiate discussion with peers, focusing on the bullet-points below. When resuming sessions in the conference room, 3 participants will disclose key findings from the discussion and results will be debated.

LABELING UPDATES & MDR/IVDR PROVISIONS

  • New definitions & areas of change
  • Enhanced transparency in IFUs
  • Disclosing residual risks
  • Extension of labeling to accessories

 

2:00 UDI COMPLIANCE STRATEGY FOR EUROPE

  • Overview of EU UDI & global UDI requirements
  • UDI data submissions & EUDAMED
  • Incorporating international standards in UDI implementation

Céline Bourguignon, Director Global Regulatory Policy, WW Gov. Affairs & Policy
JOHNSON & JOHNSON

MEDICAL DEVICE TRACK:
Medical Device Track Chairperson:
Rita Peeters
Sr Director, Regulatory Affairs Policy & Intelligence EMEA
JOHNSON & JOHNSON

2:45 PRACTICAL INSIGHTS INTO DEVICE PRODUCT RECLASSIFICATION

  • Review of new classification regime
  • Higher levels of risks in product use
  • Transition from one class to another
  • Focus on the documentation process

Annabelle Bruyndonckx, Of Counsel, SIMMONS & SIMMONS

Emmanuel Garnier, Managing Associate, SIMMONS & SIMMONS

IVD TRACK:
IVD Track Chairperson:
Luminita Tulea
Senior Manager Regulatory Affairs EMEAI
BECKMAN COULTER

2:45 PRACTICAL INSIGHTS INTO IVD PRODUCT RECLASSIFICATION

  • Review of new classification regime
  • Higher levels of risks in product use
  • Transition from one class to another
  • Focus on the documentation process

Claudia Solimeo Meneghisse, Senior Regulatory Affairs Manager, TECAN

3:30 COFFEE & NETWORKING BREAK

 

3:50 WORKSHOP: IMPACT ASSESSMENT – IDENTIFYING NECESSARY REGULATORY REVISIONS

  • Securing a clear understanding of impact on product lines
  • Conducting gap assessments against the MDR
  • Risk-based approach & documenting the revision
  • Engaging other teams to ensure all areas are addressed
  • Implementing a detailed regulatory revision plan

Karina Hellbert, Attorney-at-Law & Head of Life Sciences, FIEBINGER POLAK & PARTNER RECHTSANWÄLTE

 

4:35 PRACTICAL STEPS IN RESTRUCTURING CORPORATE REGULATORY STRATEGIES

  • Evaluating the impact of regulations on product lines
  • Integration of new requirements in regulatory framework
  • Timelines for compliance & impact on budget
  • Deploying regulatory changes within corporate departments
  • Considering flexibility & potential changes

Rainer Voelksen, VP Quality & Regulatory Affairs, OCCLUTECH

MEDICAL DEVICE TRACK:

5:20 WORKSHOP: BUILDING A REGULATORY BUSINESS CASE TO OBTAIN CORPORATE APPROVAL

  • Communicating the importance of timely implementation
  • Incorporating business priorities & corporate goals
  • Human & financial resources investment incentives
  • Detailing the regulatory revision & implementation plan

Susana de Azevedo Wäsch, Head of Global Regulatory Affairs
GEISTLICH PHARMA

Marianna Hofer, Senior Regulatory Affairs Manager
NOBEL BIOCARE

IVD TRACK:

5:20 WORKSHOP: BUILDING A REGULATORY BUSINESS CASE TO OBTAIN CORPORATE APPROVAL

  • Communicating the importance of timely implementation
  • Incorporating business priorities & corporate goals
  • Human & financial resources investment incentives
  • Detailing the regulatory revision & implementation plan

Carsten Krafcsik, Head Regulatory Affairs Switzerland
TECAN

6:05 CLOSING REMARKS & DAY 1 CONCLUSION

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 Monday, September 25. Please note that dinner expenses must be covered by each participant individually.