Fortbildung bei der DGRA e.V.

DGRA-Jahreskongress

Jahr 2004

16. - 17. Juni 2004 in Bonn

Moderation

Prof. Burkhard Sträter

Termine

Mittwoch, 16. Juni 2004 | 10.00 Uhr bis 19.00 Uhr
Donnerstag, 17. Juni 2004 | 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

  • Programmvorschau Änderungen vorbehalten
     

    Programm am 21. Juni 2004

       
    10.00 Welcome address by Professor K.-W. Glombitza - President of the DGRA
      A. Implementation of the review 2004 in the enlarged European Union
    Regulatory Challenges from EU-Commission view point
    Dr. Birka Lehmann, EU Commission, Pharmaceutical Unit, Brussels
       
    11.15 Coffee Break
       
    11.45 B. The networking medicines agencies in Europe
      Dr. Jytte Lyngvig, Lægemiddelstyrelsen, Kopenhagen
    EMEA Management Board, Vice-chairman
       
    13.00 Lunch Break
       
    14.30 C. Innovations in the decentralized procedure and in mutual recognition
      Dr. P. Bachmann, BfArM, Bonn
      D. Regulatory strategies in the new European system
    Dr. Ulrich Granzer, Granzer Regulatory Consulting & Services, München
       
    15.45 Coffee Break
       
    16.15 E. Analysis of safety data for gene therapy clinical studies
      PD Dr. Steven Hirschfeld, FDA, Rockville
      F. Regulatory aspects of gene transfer medicinal products
    Dr. Ch. Buchholz, PEI, Langen
      G. FDA – EMEA Interaction ImplicationsRepercussions for the pharmaceutical industry
    Dr. Isabelle Stöckert, BayerHealthcare AG, Wuppertal
    (Ends at around 18.00)
       
    19.00 Evening program at Hotel Königshof, Bonn
      Award of the Walter Cyran Medal 2004
    Eulogy: Professor H. G. Schweim
    Award of the certificates to the Master of Drug Regulatory Affairs (M.D.R.A.) by Professor K.-W. Glombitza, Bonn University
    Followed by reception with buffet at Hotel Königshof (open-ended)
       
       
     

    Programm am 17. Juni 2004

       
    9.00 Opening by the moderator B. Sträter (Attorney-at-Law)
      H. Clinical Trials Directive (2001/20/EC) – implementation in the member states
       
      1. Introduction to the topic
    Prof. Dr. Barbara Sickmüller,  BPI, Member of EFPIA STR- Policy Committee
      2a. Status of the procedure from the point of view of the member states
    Dr. Brian Davis, Medicines and Healthcare, Products Regulatory Authority (MHRA), London
    Dr. Kerstin Westermark, Läkemedelsverket, Uppsala
       
    10.30 Coffee Break
       
    11.00 2b. Status of the procedure from the point of view of the member states
      Prof. Dr. János Borvendég, National Institute of Pharmacy, Budapest
    Dr. Hartmut Krafft, PEI, Germany
    MinRat. PD Dr. Walter Schwerdtfeger, BMGS, Germany
       
      Panel discussion with the above speakers
       
    13.00 End of annual conferenc
       
    14.00 DGRA members’ meeting
      Moderator: Prof. Dr. H. G. Schweim
  • Kostenbeitrag und Stornierungen

    For DGRA members: € 400,-
    For nonmembers: € 550,-

    For DRA students and institution representatives who are also DGRA members: € 200,-

    • Up to two weeks before beginning of conference: € 50,-
    • Up to one week before beginning of conference: 50% of fee
    • Late cancellations: full conference fee if a substitute participant cannot be put forward

    In the case of cancellation by the organizer, any fees already paid will be fully reimbursed.

  • Anreise und Unterkunft

    Hotel (Günnewig) Bristol
    Prinz-Albert-Strasse 2
    53113 Bonn

    Tel.: +49 (0) 228/26 98-0
    Fax: +49 (0) 228/26 98-2 22


    Hotel (Günnewig) Residence
    Kaiserplatz 11
    53113 Bonn

    Tel.: +49 (0) 228/2697-0
    Fax: +49 (0) 228/2697-777


    Hotel Königshof
    Adenauerallee 9
    53111 Bonn

    Tel.: +49 (0) 228/260 10
    Fax: +49 (0) 228/260 15 29


    Hotel Maritim
    Godesberger Allee
    53175 Bonn

    Tel.: +49 (0) 228/81 08 845
    Fax: +49 (0) 228/81 08 765


    There are a limited number of rooms for participants at the aforementioned hotel.

    Please mention this conference when making your reservation.
    (The Hotel Königshof is situated about five minutes on foot from Hotel Bristol and Residence.)

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

    DGRA-Jahreskongress 2004
    16. und 17. Juni 2004 in Bonn

    Vorträge am 16. Juni 2004

    Implementation of the review 2004 in the enlarged European Union
    Dr. Birka Lehmann, EU Commission, Pharmaceutical Unit, Brussels 

    The Networking Medicines Agencies in Europe
    Dr. Jytte Lyngvig, Lægemiddelstyrelsen, Kopenhagen, EMEA Management Board 

    Innovations in the Decentralized Procedure and Mutual Recognition
    Dr. Susanne Keitel, BfArM, Bonn
     
    Innovations in the Decentralised Procedure and in Mutual Recognition
    Dr. Peter Bachmann, BfArM, Bonn

    Regulatory Strategies in the New European System
    Dr. Ulrich Granzer, Granzer Regulatory Consulting & Services, München 

    FDA CBER Gene Therapy Data Base: Preliminary Analysis of a Work in Progress
    Dr. Steven Hirschfeld, FDA, Rockville, USA

    Regulatory Aspects of Gene Transfer Medicinal Products
    PD Dr. Christian J. Buchholz, Paul-Ehrlich-Institut (PEI), Langen 

    FDA - EMEA Interaction Implications for the Pharmaceutical Industry - Part 1
    FDA - EMEA Interaction Implications for the Pharmaceutical Industry - Part 2
    Dr. Isabelle Stöckert, Bayer HealthCare AG, Wuppertal

    Vorträge am 17. Juni 2004

    Clinical Trials Directive (2001/20/EC) – Implementation in the EU - Member States
    Prof. Dr. Barbara Sickmüller, Bundesverband der Pharmazeutischen Industrie (BPI), Berlin 

    Clinical Trials Directive (2001/20/EC) - Implementation in the UK
    Dr. Brian Davis, MHRA, London 

    Implementing the Directive - from the Swedish Perspective
    Dr. Kerstin Westermark, Läkemedelsverket, Uppsala

    Impact of the Directive 2001/20/EC on the clinical trial regulation in Hungary
    Prof. Dr. János Borvendég, National Institute of Pharmacy, Budapest 

    Clinical Trials Directive (2001/20/EC) Implementation in the member states
    Hartmut Krafft, Paul-Ehrlich-Institut (PEI), Langen 

    Umsetzung der GCP-Richtlinie in Deutschland
    Ministerialrat Priv.-Doz. Dr. Walter Schwerdtfeger, Bundesministerium für Gesundheit und Soziale Sicherung, Bonn