Fortbildung bei der DGRA e.V.

DGRA-Jahreskongress

Jahr 2010

15. - 16. Juni 2010 in Bonn

Moderation

Prof. Burkhard Sträter

Termine

Dienstag, 15. Juni 2010 | 09.30 Uhr bis 19.00 Uhr
Mittwoch, 16. Juni 2010 | 09.30 Uhr bis 14.00 Uhr Termin in den eigenen Kalender übertragen

Veranstaltungsort

Wasserwerk Bonn
Hermann-Ehlers-Straße Eingang V, 53113 Bonn
Tel.: +49 (0)228 / 92 67 - 0
Routenplaner

Download

  • Programmvorschau Änderungen vorbehalten
     

    Programm am 15. Juni 2010
       
    9.30 Opening of the Annual Congress and Introduction to morning session, Dr. Ulrich Granzer
       
    10.00 I. German Competent Authorities as Part of the Network of European Drug Regulators
     
    • legal tasks
    • primary areas of responsibility
    • fulfilment of tasks within the network
    • possible developments
    PD Dr. Walter Schwerdtfeger
       
      A. New challenges for the EMA – Road Map 2015?
    Dr. Martin Terberger, EU Commission
       
    11.00 Coffee break
       
    11.30 B. News from PEI
      Prof. Dr. Klaus Cichutek, PEI
       
      C. News from BfArM
      Dr. Karl Broich, BfArM
       
    12.30 Panel discussion
       
    13.00 Lunch break
       
    14.30 II. AFSSAPS - Inclusion of external experts into the review process
      Prof. Philippe Lechat, AFSSAPS France
       
    15.15 Coffee break
       
    15.45 III. Update from the EMA
     
    • Outcome of the public consultation on the Road Map to 2015
    • Optimizing project management and scientific assessment
    Noël Wathion, EMA
       
    16.30 IV. Panel discussion with all speakers
       
    17.15 Award of “DGRA Förderpreis 2009”
      (ends at around 17.30)
       
    19.00 Pre-dinner speech
      Reception and buffet at Hotel Königshof
       
       
     

    Programm am 16. Juni 2010
       
    9.30 9th Award of the Walter Cyran Medal
       
    10.00 V. Pharmacovigilance
      Presentation of the new content and Discussion with the panel and participants
    • Introduction and general overview
    Prof. Dr. Barbara Sickmüller, BPI
     
    • Challenges of BfArM
    Dr. Ulrich Hagemann, BfArM
     
    • Industrial view
    Dr. Elmar Kroth, BAH
       
    11.00 Coffee break
       
    11.30 VI. Variation update
     
    • Variations of biological products
    Dr. Jan Müller-Berghaus, PEI
     
    • Industrial perspective - first experiences
    Dr. Barbara Gansewendt, Bayer Vital
       
    12.30 Panel discussion with all speakers
       
    13.00 Lunch/ Snack
       
    14.00 DGRA Members’ Meeting: including
     
    • Election of DGRA board
    • Amendment of the statutes
    (ends at around 15.30)
  • Kostenbeitrag und Stornierungen

    For DGRA members: € 460,-
    For non-members: € 590,-

    Student price: Students of DRA course (MDRA XI) and delegates of bodies (Behörden) who are members of the DGRA: € 260,-

    • Up to two weeks before the first day of the confere nce(1-June-2010): € 50,-
    • Up to one week before the first day of the conference (08-June-2010): 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

    Hotel (Günnewig) Bristol
    Prinz-Albert-Straße 2
    D-53113 Bonn
    Tel.: 0228/26 98-0
    Fax: 0228/26 98-2 22


    Hotel Hilton
    Berliner Freiheit 2
    D-53111 Bonn
    Tel.: 0228/7269-0
    Fax: 0228/7269-700

    Sternhotel
    Markt 8
    D-53111 Bonn
    Tel.: 0228/7267-0
    Fax: 0228/7267-125


    Hotel (Günnewig) Residence
    Kaiserplatz 11
    D-53113 Bonn
    Tel.: 0228/2697-0
    Fax: 0228/2697-777


    Villa Godesberg
    Mirbacherstr. 2
    53173 Bonn - Bad Godesberg
    Tel.: 0228 / 83 006-0
    Fax: 0228 / 83 006-90


    Hotel Maritim
    Godesberger Allee
    D-53175 Bonn
    Tel.: 0228/81 08-0
    Fax: 0228/81 08-811


    A limited number of rooms are available for participants at special rates in the hotels listed below. When making reservations please refer to this event.

  • Walter-Cyran-Medaille
    Walter-Cyran-Medaille
  • Mitgliederversammlung Mitgliedern vorbehalten
    Bitte melden Sie sich hier mit Ihren Zugangsdaten an und klicken Sie danach erneut auf Anmeldung.
  • Unterlagen

    Vorträge am 15. Juni 2010

    German Competent Authorities as Part of the Network of European Drug Regulators
    PD Dr. Walter Schwerdtfeger

    New Challenges for the EMA: Implementation of the 'pharmaceutical package' and beyond
    Stefan Führing, EU Commission, Brüssel

    News from the Paul-Ehrlich-Institut
    Prof. Klaus Cichutek, PEI, Langen

    New Challenges for EMA and NCA: News from BfArM
    Dr. Karl Broich, BfArM, Bonn

    AFSSAPS: Inclusion of external experts into the review process
    Prof. Philippe Lechat, AFSSAPS, Saint Denis

    New Challenges for EMA and NCA: Update from the EMA
    Noël Wathion, European Medicines Agency (EMA), London

    DGRA-Förderpreis 2009

    Regulatory Strategies and Practical Aspects for the Development and Authorisation of Orphan Drugs in the EU
    Matthias Dormeyer

    Vorträge am 16. Juni 2010

    Pharmacovigilance - PharmaPackage - Introduction and general overview
    Prof. Dr. Barbara Sickmüller, BPI, Berlin

    Pharmacovigilance- Content of the New EU Legislation and Challenges for BfArM
    Dr. Ulrich Hagemann, BfArM, Bonn

    EU Pharma Package – Industrial View
    Dr. Elmar Kroth, BAH, Bonn

    Variations for Biologics
    Dr. Jan Müller-Berghaus, PEI, Langen

    Variations Update: Industrial Perspective – First Experiences
    Dr. Barbara Gansewendt, Bayer Vital, Leverkusen

zurück zur Übersicht