Fortbildung bei der DGRA e.V.

DGRA-Jahreskongress

Jahr 2006

9. - 10. Mai 2006 in Bonn

Moderation

Prof. Burkhard Sträter

Termine

Dienstag, 9. Mai 2006 | 10.00 Uhr bis 19.00 Uhr
Mittwoch, 10. Mai 2006 | 09.00 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 9. Mai 2006
       
    9.30 Welcoming Speech by Prof. Dr. K.-W. Glombitza
      President of the DGRA
       
    10.15 Benchmarking European Medicines Agencies:
      Role of the EMEA in the Regulatory System
    • Searching for best practices
    • Pioneer, partner or competitor
    • Expectations of cooperation with the member states
    Dr. Marijke Korteweg, EMEA, London
      Outcome and Benefit of Benchmarking – Expectations of the German Ministry of Health
    PD Dr. Walter Schwerdtfeger, German Ministry of Health, Bonn
       
    11.30 Coffee Break
       
    12.00 Role of the National Competent Authorities in the European Medicines Network
      Denmark – Danish Medicines Agency
    • Challenges for National Competent Authorities in the different licensing processes
    Dr. Per Helboe, Danish Medicines Agency, Copenhagen
      The Netherlands – Medicines Evaluation Board
    • Status of reorganization of the National Agency
    • Experience with implementation and expectations in cooperation within the EU system
    Dr. Aginus Kalis, MEB, The Hague
       
    13.00 Lunch Break
       
    14.30 Germay - the reorganisation of the Federal Institute for drugs and medical devices
     
    • Concept, objective, consequences
    Prof. Dr. Reinhard Kurth, Federal Institute for Drugs and Medical Devices, Bonn
       
      Panel discussion with the above speakers
       
    15.30 Coffee break
       
    16.00 Quality assurance in the CHMP
     
    • Peer-review procedure
    • Assignment of rapporteurship
    Dr. Manfred Haase, Paul Ehrlich Institute, Langen
       
      Award of the Walter Cyran Medal
    (Ends at around 17.30)
       
    19.00 Evening Programme on the Rhine Boat “MS Loreley”
      Predinner Speech:
    Introduction of the Academic Chair for Drug Regulatory Affairs at Bonn University
    Prof. Dr. Harald G. Schweim, Bonn University
       
       
     

    Programm am 10. Mai 2006
       
    9.00 The Paul Ehrlich Institute –
      Centre of Excellence for Vaccines, Blood Products and Emerging Therapies
    Prof. Dr. Johannes Löwer, Paul Ehrlich Institute, Langen
       
    9.30 Better Medicines for Children – Paediatric Drug Development in the EU
      1. Paediatric medicines – the new Regulation in the EU
    • Status of the legislation process
    • Obligations and incentives for industry
    • European Funding for Paediatric Research
    Dr. Julia Dunne, MHRA, London
       
      2. Paediatric Working Party and Paediatric Committee
    • Inventories of therapeutic needs
    • Paediatric investigation plans – waivers - deferrals
    Dr. Annic Weyersberg, EMEA, London
       
    11.00 Coffee break
       
    11.30 3. EU paediatric regulation – consequences for drug development
      Dr. Klaus Rose, F. Hoffmann-La Roche Ltd., Basel
       
    12.15 4. Paediatric Use Marketing Authorisation (PUMA)
      from a National Competent Authority point of view
    Dr. Susanne Keitel, Federal Institute for Drugs and Medical Devices, Bonn
       
    13.00 End
       
    14.00 DGRA Members’ Meeting – Elections of the board
  • Kostenbeitrag und Stornierungen

    For DGRA members: € 420,-
    For non-members: € 580,-

    For students of the DRA course and delegates of bodies who are members of the DGRA: € 210,-

    • 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

    Vom 09. auf den 10. Mai sind unter dem Stichwort "DGRA" in folgenden Hotels Zimmerkontingente reserviert:

    Hotel Residence
    Kaiserplatz 11
    53113 Bonn
    Tel.: 0228/26 97-0
    Fax: 0228/26 97-777

    € 95,- inkl. Frühstück (fußläufig zum Bahnhof, per Taxi ca. 25 Minuten zum Tagungsort)


    Hotel Bristol
    Prinz-Albert-Str. 2
    53113 Bonn
    Tel.: 0228/26 98-0
    Fax: 0228/26 98-222

    €€ 115,- inkl. Frühstück (fußläufig zum Bahnhof, per Taxi ca. 25 Minuten zum Tagungsort)


    Hotel Maritim
    Godesberger Allee
    53175 Bonn
    Tel.: 0228/81 08-0
    Fax: 0228/81 08-811
    €
    € 129,- /€ € 166,- inkl. Frühstück (per Taxi ca. 15 Minuten zum Tagungsort, ca. 20 Minuten zum Abendprogramm)


    Hotel Kanzler
    Adenauerallee 148
    53113 Bonn
    Tel.: 0228/68 44-0
    Fax: 0228/68 44 180

    €€ 136,-/€ € 141,- inkl. Frühstück (fußläufig zum Tagungsort in ca. 15 Minuten)


    Hotel Hilton
    Berliner Freiheit 2
    53111 Bonn
    Tel.: 0228/72 69-0
    Fax: 0228/72 69-700

    €€ 139,- inkl. Frühstück (fußläufig zum Abendprogramm, per Taxi ca. 25 Minuten zum Tagungsort) hier sind Zimmer vom 08. bis 11. Mai reserviert

  • 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 9. Mai 2006

    Benchmarking European Medicines Agencies: Role of the EMEA in the Regulatory System
    Dr. Marijke Korteweg, EMEA, London

    Outcome and Benefit of Benchmarking - Expectations of the German Ministry of Health
    PD Dr. Walter Schwerdtfeger, German Ministry of Health, Bonn

    Role of the National Competent Authorities in the European Medicines Network:

    Denmark - Danish Medicines Agency
    Dr. Per Helboe, Danish Medicines Agency, Copenhagen

    The Netherlands - Medicines Evaluation Board
    Dr. Anginus Kalis, MEB, The Hague

    Germany - The Reorganisation of the Federal Institute for Drugs and Medical Devices (BfArM)
    Prof. Dr. Reinhard Kurth, BfArM, Bonn

    Quality Assurance in the CHMP
    Dr. Manfred Haase, Paul Ehrlich Institute, Langen

    Vorträge am 10. Mai 2006

    The Paul Ehrlich Institute - Centre of Excellence for Vaccines, Blood Products and Emerging Therapies
    Prof. Dr. Johannes Löwer, Paul Ehrlich Institute, Langen

    Paediatric Medicines - The New European Legislation
    Dr. Annic Weyersberg, EMEA, London

    Improving Drug Therapy for Children: The Planned EU Regulation From A Global Perspective
    Dr. Klaus Rose, F. Hoffmann-La Roche Ltd., Basel

    Paediatric Use Marketing Authorisation (PUMA) from a National Competent Authority Point of View
    Dr. Susanne Keitel, BfArM, Bonn

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