Fortbildung bei der DGRA e.V.

DGRA-Jahreskongress

Jahr 2009

12. - 13. Mai 2009 in Bonn

Moderation

Prof. Burkhard Sträter

Termine

Dienstag, 12. Mai 2009 | 09.30 Uhr bis 19.00 Uhr
Mittwoch, 13. Mai 2009 | 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

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  • Programmvorschau Änderungen vorbehalten
     

    Programm am 12. Mai 2009
       
    9.30 Opening of the Annual Congress, Dr. Ulrich Granzer
       
    9.45 I. 2008 Pharmaceutical Package
     
    • Aims of the EU Commission
    • Implementation status
    Dr. Martin Terberger, EU Commission
       
      A. Consequences and Significance for the Pharmaceutical Market in Germany
    PD Dr. Walter Schwerdtfeger, German Ministry of Health
       
    11.00 Coffee break
       
    11.30 B. Strengthening of Pharmacovigilance - Expectations and Requirements for a new system
      Dr. Ulrich Hagemann, BfArM
       
      C. PV-Risk Assessment Advisory Committee – PRAAC
    Responsibilities and Cooperation with NCAs
    Dr. Brigitte Keller-Stanislawski, PEI
       
    12.30 Panel discussion
       
    13.00 Lunch break
       
    14.30 II. Safety Measures in the new Pharmaceutical Vigilance System
     
    • Steps of the procedure for nationally, decentrally and centrally authorized pharmaceutical products
    • Evaluation
    • Risk-management plans: content and function
    Dr. Harald Tietz, Lilly Deutschland and
    Dr. Brigitte Keller-Stanislawski, PEI
       
    15.15 Coffee break
       
    15.45 III. New Variation Regulation
     
    • Structure of the new system
    • How it applies to national authorizations
    • Guideline for defining variation types
    • Status of the consultation and procedure
    Susanne Winterscheid, BfArM
       
    16.30 IV. Impact on Implementation by BfArM
      Dr. Karl Broich, BfArM
       
      Panel discussion with all speakers
       
    17.15 8th Award of the Walter Cyran Medal
      (ends at around 18.00)
       
    19.00 Pre-dinner speech
      Reception and buffet
       
       
     

    Programm am 13. Mai 2009
       
    9.30 V. 15th Amendment to the German Drug Law
      Presentation of the content and Discussion with the panel and participants
    • Introduction and general overview
    Prof. Burkhard Sträter, Attorney
    • Advanced Therapies
    Dr. Christa Schröder, PEI
       
    11.00 Coffee break
       
     
    • Tissue Engineering
    Matthias Wilken, BPI
    • Impact on “Länderbehörden”

    Dr. Regine Leo, GMP/GCP Inspectorate Hannover
       
    12.30 Panel discussion with all speakers
       
    13.00 Lunch/ Snack
       
    14.00 DGRA Members’ Meeting
  • Kostenbeitrag und Stornierungen

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

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

    • Up to two weeks before the first day of the confere nce(28-Apr-09): € 50,-
    • Up to one week before the first day of the conference (05-May-09): 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


    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


    Hotel Königshof
    Adenauerallee 9
    D-53111 Bonn
    Tel.: 0228/26 01-0
    Fax: 0228/26 01-529


    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 12. Mai 2009

    The European Commission’s 2008 Pharmaceutical Package
    Dr. Martin Terberger, EU Commission, Brussels

    2008 Pharmaceutical Package - Consequences and Significance for the Pharmaceutical Market in Germany
    PD Dr. Walter Schwerdtfeger, BMG, Bonn

    Strengthening of Pharmacovigilance - Expectations and requirements for a new system
    Dr. Ulrich Hagemann, BfArM, Bonn

    Pharmacovigilance Risk Advisory Committee - PRAAC Responsibilities and Cooperation with NCAs
    Dr. Brigitte Keller-Stanislawski, PEI, Langen

    Safety Measures in the new Pharmacovigilance System
    Dr. Harald Tietz, Lilly Deutschland GmbH, Bad Homburg

    Safety Measures in the New Pharmaceutical Vigilance System
    Dr. Brigitte Keller-Stanislawski, PEI, Langen

    New Variation Regulation
    Susanne Winterscheid, BfArM, Bonn

    2008 Pharmaceutical Package - Impact on Implementation by BfArM
    Dr. Karl Broich, BfArM, Bonn

    Vorträge am 13. Mai 2009

    15. AMG-Novelle
    Prof. Burkhard Sträter, Anwaltskanzlei Sträter, Bonn

    Anpassung an EU-Recht: Arzneimittel für neuartige Therapien
    Dr. Christa Schröder, PEI, Langen

    15. AMG-Novelle - Tissue Engineering
    Matthias Wilken, BPI, Berlin

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