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DGRA-Schools

DGRA-Schools | Zulassung USA

21. - 22. März 2012 in Bonn

Termine

Mittwoch, 21. März 2012 | 09.00 Uhr bis 17.30 Uhr
Donnerstag, 22. März 2012 | 09.00 Uhr bis 16.30 Uhr Termin in den eigenen Kalender übertragen

Veranstaltungsort

Hotel Residence
Kaiserplatz 11, 53113 Bonn
Tel.: 0228 - 26 97-0
Routenplaner

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  • Programmvorschau Änderungen vorbehalten
     

    Programm am 21. März 2012
       
    9.00 I. Introduction: US Pharma Market
     
    • Defintion, characterization
    Dr. Max Wegner
       
    09.30 II. History of Key Regulations
     
    • Organisation of HHS
    • Structure of FDA
    • FDA Activities
    Dr. Ulrich Granzer
       
    10.30 Coffee break
       
    11.00 III. IND Process
     
    • Principles, process, IND Regulations
    • Responsibilities of Sponsors and Investigators
    Dr. Isabelle Stöckert
       
    12.30 Lunch break
       
    13.30 IV. NDA Process
     
    • US Code of Federal Regulations (CFR)
    • PDUFA
    • Good Review Management Principles and Practices
    • Successful NDA submission
    Dr. Max Wegner
       
    15.00 Coffee break
       
    15.30 V. VIII. Biologicals
     
    • Defintion, characterization
    • Principles, process, US Regulations
    Dr. Ulrich Granzer
       
    16.30 VI. Medical Devices
     
    • Defintion, characterization
    • Principles, process, US Regulations
    Dr. Ulrich Granzer
       
    17.30 end
       
       
     

    Programm am 22. März 2012
       
    9.00 VII Marketing Exclusivity/ANDA
     
    • Patent extensions
    • Data exclusivity
    • ANDA Process
    Dr. Ulrich Granzer
       
    9.45 Coffee break
       
    10.15 VIII. How to co-operate with FDA
     
    • Regulatory Strategy
    • Meetings with FDA
    Dr. Isabelle Stöckert, Dr. Max Wegner
       
    12.15 Lunch break
       
    13.15 IX. Pediatrics
     
    • Pedriatric Initiatives, Clinical Studies
    • Legislation: PREA, BDCA, PeRC
    Dr. Max Wegner
       
    14.15 VI. Post-Approval Activities
     
    • Reporting requirements to FDA
    • Changes to an approved product
    Dr. Isabelle Stöckert
       
    15.00 Coffee break
       
    15.30 XI. Comparison US vs. EU
     
    • Legislation, Legal Bodies, Timelines
    • Regulatory Enviroment, Scientific Advice, Procedures
    Dr. Isabelle Stöckert
       
    16.30 end
       
       
      Anfahrtskizze zum Hotel Residence, Bonn
  • Kostenbeitrag und Stornierungen

    € 750,- for DGRA Members and M.D.R.A. students course 13. Number of participants is limited.

    • Up to two weeks before the first day of the school (7-Mar 12): € 50,-
    • Up to one week before the first day of the school (14-Mar 12): 50% of fee
    • Late cancellations: full conference fee if a substitute participant (DGRA member) cannot be put forward

    In the event of cancellation by the organizer, any fees already paid will
    be fully reimbursed.

  • Anreise und Unterkunft

    A limited number of rooms are available for participants at special rates in the hotel below.
    When making reservations (up to end of February) please refer to DGRA.

    Hotel Residence, Bonn
    Phone: +49 - 228/26970

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