Fortbildung bei der DGRA e.V.

DGRA-Jahreskongress

Jahr 2008

17. - 18. Juni 2008 in Bonn

Moderation

Prof. Burkhard Sträter

Termine

Dienstag, 17. Juni 2008 | 09.30 Uhr bis 19.00 Uhr
Mittwoch, 18. Juni 2008 | 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 17. Juni 2008
       
    9.30 Welcoming Speech by Dr. Ulrich Granzer
       
    9.45 Pharmaceuticals in the EU: Heading for the Future – "Have your Say" Initiative
      Initiative of the EU Commission: Public consultation on the future of pharmaceuticals for human use in the EU
    • Background and present state of play
    Martin Terberger, EU Commission, Brussels
      Revising the pharmaceutical landscape in the EU – The industry ́s perspective
    Christine-Lise Joulou, EFPIA, Brussels
       
    10.45 Coffee break
       
    11.15 An Eu-Member State position
      Dr. Aginus Kalis, MEB, The Hague
      Transatlantic Simplification of Administrative Procedures in the Area of Pharmaceuticals
    Arielle North, EMEA, London
       
    12.15 Panel Discussion
       
    12.45 Lunch break
       
    14.15 Heading for New Approaches – Future of the BfArM in the EU MA System
      Prof. Dr. Johannes Löwer, BfArM, Bonn
       
      Advanced Therapies: Implementing New Regulations
    • Products concerned
    • Authorisation procedures
    Prof. Dr. Claus Cichutek, PEI, Langen
       
    15.15 Coffee break
       
    15.45 Consequences for research-based industry
      Dr. Gabriele Schäffner, NDA, Freiburg
       
    16.15 Panel Discussion with all Speakers
       
    16.40 One Year Pediatric Committee – PDCO
     
    • Main tasks
    • Problems of ongoing PIP ́s
    • Experience and outcome
    Prof. Daniel Brasseur, EMEA, London
       
    17.00 Award of the Walter Cyran Medal
      (ends at around 17.30)
       
    19.00 Pre-Dinner Speech: 10 Years DGRA – What Next?
      Dr. Ulrich Granzer, Chair of the DGRA
    Reception and buffet
       
       
     

    Programm am 18. Juni 2008
       
    9.30 EU Variations Regulations
     
    • Revision of the EU Variations Regulations – outcome of the consultation process and further steps
    Dr. Susanne Keitel, EDQM/DEQM, Strasbourg
     
    • Consequences for the pharmaceutical industry – Will the changes make the EU a more competitive market place?
    Dr. Rüdiger Faust, Grünenthal GmbH, Aachen
       
    11.00 Coffee break
       
    11.30 Consequences for competent authorities - Will the change simplify administrative hurdles?
      Dr. Truus Janse-de Hoog, MEB, The Hague
       
      EU Variation System binding for national MA? – Consequences for authorities
      Susanne Winterscheid, BfArM, Bonn
       
    12.30 Panel Discussion with all Speakers
       
    13.00 End
       
    14.00 DGRA Members’ Meeting
  • Kostenbeitrag und Stornierungen

    For DGRA members: € 450,-
    For non-members: € 590,-

    Students special: Students of the DGRA courses (MDRA I to IX) and delegates of bodies who are members of the DGRA: € 240,-

    • Up to two weeks before the first day of the conference: € 50,-
    • Up to one week before the first day of the conference: 50% of fee
    • Later 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


    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 17. Juni 2008

    Pharmaceuticals in the EU: Heading for the Future
    Martin Terberger, EU Commission, Brussels

    Revising the Pharmaceutical Landscape in the EU
    Christine-Lise Julou, EFPIA, Brussels

    Heading for the Future: Convergence of medical products
    Dr. Aginus Kalis, MEB, The Hague

    Transatlantic Simplification of Administrative Procedures in the Area of Pharmaceuticals
    Arielle North, EMEA, London

    Heading for New Approaches - Future of the BfArM in the EU MA System
    Prof. Dr. Johannes Löwer, BfArM, Bonn

    Advanced therapy medicinal products
    Prof. Dr. Claus Cichutek, PEI, Langen

    Advanced therapies: Implementing New Regulations - Consequences for research-based industry
    Dr. Gabriele Dallmann (formerly Schäffner), NDA, Freiburg

    EU  Paediatric Regulation - One Year PDCO
    Prof. Daniel Brasseur, EMEA, London

    Vorträge am 18. Juni 2008

    Revision of the EU Variations Regulations - Outcome of the Consultation Procedure and Further Steps
    Dr. Susanne Keitel, EDQM/DEQM, Strasbourg

    Consequences for the pharmaceutical industry - Will the changes make the EU a more competitive market place?
    Dr. Rüdiger Faust, Grünenthal GmbH, Aachen

    Consequences for competent authorities - Will the change simplify administrative hurdles?
    Dr. Truus Janse-de Hoog, MEB, The Hague

    EU-Variation System binding for natioal MA?
    Susanne Winterscheid, BfArM, Bonn

BILDERGALERIE

zurück zur Übersicht