Fortbildung bei der DGRA e.V.

DGRA-Schools

1. DGRA-School | Asia

14. - 15. Oktober 2014 in Bonn

Termine

Dienstag, 14. Oktober 2014
Mittwoch, 15. Oktober 2014 Termin in den eigenen Kalender übertragen

Veranstaltungsort

Hotel Bristol
Prinz-Albert-Straße 2, 53113 Bonn
Tel.: 0228 - 26 98-0
Routenplaner

  • Programmvorschau Änderungen vorbehalten

    Programme October 14, 2014:

     
       

    9.00 – 09:30 a.m.

    I. Introduction: Asian Market
    •    Defintion, characterization
    Dr. Michael Gebauer
       

    09.30 – 10:30 a.m:

    II. Requirements of Clincial Trials //Scientific advice
    •    Where and why to conduct clinical studies in Asia
    •    Ethnical Sensitivity (ICH E5 in non ICH countries)
    •    Regulatory hurdles (CTA/IND; processes)
    •    Scientific Advice in Asia
    NN
       

    10:30 – 11:00 a.m.

    Coffee break
       

    11:00 – 12:30 a.m.

    III. Quality/ Stability Requirements
    •    CMC documentation (is ICH QOS + M3 sufficient?)
    •    Special Attention for stability data
    •    [SMF/PMF]
    •    PIC´s [asian members), Inspections
    •    Samples and analytical tests
    Dr. Manuel Zahn

       
    12:30 – 01:30 p.m. Lunch break
       
    01:30 – 03:00 p.m. IV. Certificates
    •    CPP´s (Certificate of Pharmaceutical Product)
    •    Other Autorisations [PoA´s], Translations
    •    Successful submission
    NN
       
    03:00 – 03:30 p.m. Coffee break
       
    03:30 – 05:30 p.m. V. Generic Marketing Authorization
    •    Regulatory Enviroment, Scientific Advice, Procedures
    NN
       
    Programme October 15, 2014:  
       
    09:00 – 09.45 a.m. VII Marketing Authorization in China
    •    CFDA, CDE
    •    Drug classification (category I-IV) RA processes, timelines
    •    IDL  vs local manufacture
    Dr. Santiago Figueroa Pérez
       
     09.45 – 10.00 a.m.  Break
       
    10.00 - 11.00 a.m. VII Marketing Authorization in China (continued)
       
    11.00 – 12:00  p.m  VIII. Marketing Authorization in India
    •    CDSCO, DCG(I)
    •    General registration processes, timelines
    •    Impact of recent developments on regulatory processes (Clinical Trials, Patents)
    Xenia Freifrau von Maltzan
       
    12:15 – 01:15 p.m. Lunch break
       
    01.15 – 02:30  p.m. IX. Marketing Authorization in Taiwan
    •    T-FDA, CDE
    •    Bridging Evaluation
    •    PMF / Manufacturer inspections
    Dr. Hsueh-Yung (Mary) Tai, TFDA
       
    02:30– 2:45 p.m. Break
       
    02:45 -  03.45 p.m. X. Marketing Authorization in South Korea
    •    MFDS (Ministry of Food and Drug Safety)
    •    Korean Bridging guideline
    •    IND and NDA, Re-examination
    Dr. Michael Gebauer
       
    03:45– 4:00 p.m. Coffee break
       
    04.00– 04:30 p.m.

    XI. ASEAN
    · ASEAN harmonization approach
    · ASEAN guidelines, ACTD
    Xenia Freifrau von Maltzan
  • Kostenbeitrag und Stornierungen

    Conference language: English

    € 750 for DGRA Members and M.D.R.A. students course 15.
    Number of participants is limited.

    Up to two weeks before the first day of the school (September 30th 2014): € 50;
    up to one week before the first day of the school (October 7th 2014): 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
    With the cooperation of DGRA e.V. and the Deutsche Bahn you travel relaxed and comfortably to your DGRA education and training events in 2014. The price for your ticket for a return trip to Bonn is 99 € (2nd class) and 159 € (1st class). Detailed information and booking options for this offer can be found here.

     

  • Unterlagen Mitgliedern vorbehalten
    Bitte melden Sie sich hier mit Ihren Zugangsdaten an und klicken Sie danach erneut auf Anmeldung.
  • Sie haben Fragen? Bitte wenden Sie sich an:
    Barbara Röcher

    Dipl.-Kauffrau Barbara Röcher
    Geschäftsführung

    Telefon: +49 (0) 228 - 368 26 46
    E-Mail: