MediTech a Medpace Company Two Continent Strategy


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Carla Kikken and Ryan Wilson's presentation at MedTech, May 2013.

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MediTech a Medpace Company Two Continent Strategy

  1. 1. EXPERTS“EU/US Marketing Authorization:Coordinating a Two Continent-Strategy”
  2. 2. The European Uniono 1 continento 27 Countrieso 23 Languageso 4,325,675 km²o 497,198,740inhabitantsContinent
  3. 3. European Union:o EU Marketing Access/Authorizationo One Approval – Access to 27 Member Stateso What do you need ?
  4. 4. European Union:o CE Mark – Safety + Performanceo ISO 13485 – Quality Standardo Technical File / Contentso Notified Bodyo Authorized Representative
  5. 5. European Union:o Timelines to Market Authorizationo Actual Placing on the Market
  6. 6. European Union:o Contents CE Mark Technical Fileo EU Clinical Data for CE Mark and FDASubmissions
  7. 7. European Union:o Device Classification – based on indicationo Exit Strategies and Milestoneso CE Mark, Patient Numbers, FU timelines
  8. 8. European Union:o Notified Body Selection / Registered with EUCommissiono Pre-meeting Notified Bodieso Determine Fast Track NB reviewso Determine milestones (CE Mark / Patient FU)o Literature Review-Equivalence
  9. 9. European Union:o Prototypeo Determine Strategyo What is available? More important: What is notavailable (yet)o Take into consideration: Languages Cultural differenceso Fastest Route to Marketing Authorizationo LIMIT Sites / IndicationsCase Study:
  10. 10. EU/US Marketing Authorization:o Define „Two Continent‟ Marketing Strategyo Testing done in accordance with ISO Standardso Clinical Protocol to cover “Two Continents” inline with Notified Body and FDAo Site Selection/Qualification for FDA-experienced Sites
  11. 11. EU/US Marketing Authorization:o Animal Testing – safety considerations Device placement Acute tissue effects Chronic Tissue effects Gross pathology and histological response
  12. 12. EU/US Marketing Authorization:o Coordinating the Strategies: Why? Save $$ More efficient use of resources Faster realization of revenue Avoid redundancy
  13. 13. United States:o Quality System and Manufacturing Information –Controls and procedures To ensure consistency in product To ensure ongoing review of product/system To ensure management commitment To ensure investigation of defects and correctiveactiono 21 CFR 820 and ISO 13485
  14. 14. United States:o Manufacturing and QS Complexity of Manufacturing• Process requiring validation Outside testing requirement Number of design iterationso Manufacturing documents and validationreports can be used for US and EUo ISO 13485 and the QSR are similar, not identical
  15. 15. “EU/US Marketing Authorization:Coordinating a Two Continent-Strategy”o Human Clinical Datao First-in-human Clinical Experience Longest duration follow-up datao Pivotal Study Results Demonstrate Safety and Effectiveness or SE Sufficient sample size for statistical support
  16. 16. “EU/US Marketing Authorization:Coordinating a Two Continent-Strategy”o Clinical Study Focus: Safety and Efficacyo Class II Devices and Non-invasive Class III Single phase is usually adequateo Class III Devices Two phase approach often required• Pilot phase – 20-50 subjects with 6 month• Pivotal phase – 100-1000 subjects with significant long termfollow-up (multi-year) in a controlled, comparative design
  17. 17. “EU/US Marketing Authorization:Coordinating a Two Continent-Strategy”o Study Duration = TIME Study duration is critical path item• Delays market release and revenue• Quarterly monitoring• Data management Investigators over-estimate their subject volume
  18. 18. “EU/US Marketing Authorization:Coordinating a Two Continent-Strategy”o Investigator / Sites Payments In the US, sites and IRBs are commanding more inpayments Competition for Investigators in studies Institutions are often a party to the contracts andcharge overheado EU experience can often suffice for US feasibilityrequirements
  19. 19. “EU/US Marketing Authorization:Coordinating a Two Continent-Strategy”o First, understand totality of the requirements In Europe In the US
  20. 20. Section DividerTHANK YOU FOR YOUR ATTENTION