7TH ANNUAL EU DEVICE AND DIAGNOSTIC REGULATION CONFERENCE

SEPTEMBER 25-26, 2017 | BRUSSELS, BELGIUM | PARK INN BY RADISSON BRUSSELS AIRPORT
Download AgendaRegister Now

DAY TWO | TUESDAY, SEPTEMBER 26

7:30 REGISTRATION & WELCOME COFFEE

 

MEDICAL DEVICE TRACK:

7:50 CHAIRPERSON’S OPENING REMARKS
Rita Peeters, Sr Director, Regulatory Affairs Policy & Intelligence EMEA
JOHNSON & JOHNSON

 

8:00 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

8:45 LEGACY PRODUCT LINE MANAGEMENT & COMPLIANCE

  • Product line withdrawal vs. continuation
  • Repurposing of data & available sources
  • Defining sufficient data amounts
  • Necessity of clinical (re)testing

Leo Hovestadt, International Regulatory Affairs & Quality Assurance Director
ELEKTA

Jana Grieb, Counsel
MCDERMOTT WILL & EMERY

 

IVD TRACK:

7:50 Chairperson’s Opening Remarks
Luminita Tulea, Senior Manager Regulatory Affairs EMEAI
BECKMAN COULTER

 

8:00 WORKSHOP: PRIORITIZATION OF IMPLEMENTATION OPERATIONS

  • Establishing regulatory priorities for the transition
  • Regulatory shift alignment with business goals
  • Development of a transition schedule & milestones

David Lansbergen, Regulatory Affairs & Quality Manager, EMEAI
SAKURA FINETEK EUROPE

9:45 COFFEE & NETWORKING BREAK

10:15 WORKSHOP: TECHNICAL FILE GAP ASSESSMENT & TRANSITION TO MDR

  • New provisions integration in existing strategy
  • Practical aspects of updating documentation
  • Use of existing documentation
  • Technical file life cycle management

Arkan Zwick, Corporate Director Regulatory Affairs
CROMA PHARMA

Matthias Binder, Senior Regulatory Affairs Manager
CROMA PHARMA


11:15 WORKSHOP: UPDATING CLINICAL STRATEGIES AGAINST THE MDR

  • Appropriate clinical data under the MDR
  • Aligning with MEDDEV 2.7.1 revision 4
  • Preparing for Clinical Evaluation Reports
  • Maintaining a compliant PMCF plan

Bassil Akra, VP – Global Focus Teams, Cardiovascular, Orthopedic & Clinical
TÜV SÜD PRODUCT SERVICE GMBH – GERMANY

10:15 EXCHANGE GROUPS: TECHNICAL FILE GAP ASSESSMENT & TRANSITION TO IVDR

  • New provisions integration in existing strategy
  • Practical aspects of updating documentation
  • Use of existing documentation
  • Technical file life cycle management

 

11:15 WORKSHOP: NEW PERFORMANCE EVALUATION & CLINICAL STRATEGY DEVELOPMENT

  • Enhanced requirements for:
    • TScientific validity
    • TAnalytic performance data
    • TClinical performance & studies
  • Justifying level of clinical evidence
  • Performance evaluation report updates

Yves Ohandja, Manager Quality & Regulatory Affairs Europe
IMMUCOR

12:15 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES


1:15 WORKSHOP: QMS COMPLIANCE WITH REGULATIONS & ISO 13485:2016

  • Updates to ISO 13485:2016 & assessing gaps in QMS
  • QMS structure integrating regulation provisions
  • Practical approach to implementing both requirements

Mayda Lopez-Belmonte, Director Business Quality South, UK/Ireland and POLO EMEA
JOHNSON & JOHNSON

2:15 WORKSHOP: REVISING POST-MARKET SURVEILLANCE & VIGILANCE

  • Tightening post-market supervision
  • Customer feedback file management
  • New reporting frequency & requirements
  • Post-market data management plan

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

2:15 GROUP DISCUSSION: UPDATING POST-MARKET SURVEILLANCE STRATEGIES

  • Post-market performance & new production reports
  • Performance evaluation assessment reporting
  • Periodic safety update reports & benefit/risk
  • Defining sufficient amounts of data
  • Post-market data management plan

Luminita Tulea, Senior Manager Regulatory Affairs EMEAI
BECKMAN COULTER

3:15 WORKSHOP: REORGANIZING THE SUPPLY CHAIN UNDER THE REGULATIONS

  • Economic Operators inclusion in supply chain
  • Unannounced audits: countering objections
  • Re-establishing contracts with partners
  • Impact on own-brand labeling & data
  • UDI data & use in the supply chain

Lukáš Bican Prikryl, Quality & Regulatory Manager CEE, EEDC, BECKMAN COULTER

Emmanuel Garnier, Managing Associate, SIMMONS & SIMMONS

 

4:15 CLOSING REMARKS & CONFERENCE CONCLUSION