Fortbildung bei der DGRA e.V.

DGRA-Jahreskongress

Jahr 2007

12. - 13. Juni 2007 in Bonn

Moderation

Prof. Burkhard Sträter

Termine

Dienstag, 12. Juni 2007 | 09.30 Uhr bis 19.00 Uhr
Mittwoch, 13. Juni 2007 | 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. Juni 2007
       
    9.30 Welcoming Speech by Prof. Dr. K.-W. Glombitza
      President of the DGRA
       
    9.45 Medicinal Products for Pediatric Use: Purpose and scope of the new EU-regulation
     
    • Affected Products
    • Consequences for line extensions
    • Provisions
    Dr. Julia Dunne, MHRA, London
       
      Pediatric Committee – PC
    • Scope
    • Composition
    • Procedures
    • Inventory of existing studies
    • Workload Management
    Dr. Daniel Brasseur, EMEA, London
       
    11.00 Legal Framework for Incentives
     
    • Patented Products
    • Rules and requirements for SPC-Extension
    • Provision
    • Orphan Medicinal Products
    • Incentives for PUMAs
    RA Burkhard Sträter, Bonn
       
    11.30 Coffee break
       
    12.00 Pediatric Investigation Plan - PIP
     
    • Affected Products and authorisation procedures
    • Content
    • Structure
    • Time lines
    Dr. Agnés Saint Raymond, EMEA, London
       
    12.30 Panel-Discussion
      with Dr. Dunne, Dr. Brasseur, RA Sträter, Dr. Saint Raymond
       
    13.00 Lunch break
       
    14.30 Ethical Considerations for Clinical Trials Performed in Children
     
    • New recommendations of the Ad hoc group for the development of implementing guidelines for Directive 2001/20/EC - State of play
    Dr. Dirk Mentzer. PEI, Langen
       
    15.15 Special considerations for clinical trials in the paediatric population –
      psychosocial, medicinal, scientific and organizational challenges
    • Obtaining informed consent and educating motivated patients
    • Development and growth
    • Small and diverse populations
    • Large, multinational, long running studies
    Dr. Reinhard Feneberg, Pediatric Unit of the KKS Heidelberg, Pediatric Network PAED-Ne
       
    16.00 Coffee break
       
    16.30 Consequences for the Pharmaceutical Industry
      Panel-Discussion with Dr. Mentzer, Dr. Feneberg, Dr. Wegner
    (Ends at around 17.30)
       
    19.00 Evening Programme
      Award of the Walter Cyran Medal
    Followed by: Reception and buffet (end open)
       
       
     

    Programm am 13. Juni 2007
       
    9.30 Electronic Regulatory Submission (ERS) in the EU – Overview
      Dr. A. Aparicio, Merck KGaA, Darmstadt
       
    10.00 ERS from the Point of View of the National Drug Agencies
     
    • Regional requirements
    • Mandatory or non-binding
    • Electronic submisson technologies
    • Electronic documents and data
    • Perspectives for the future
      A. France
    Dr. Aziz Diop, afssaps, Saint-Denis
      B. Austria
    Dr. Christa Wirthumer-Hoche, AGES PharmMed, Wien
       
    11.00 Coffee break
       
    11.30 C. United Kingdom
      Dr. David Wheeler, MHRA, London
       
    12.00 D. Germany
      Dr. K. Menges, 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,-

    For students of the DRA course (MDRA VIII) 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.: 0228/72 69 - 0
    Fax: 0228/260 15 29


    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 08 845
    Fax: 0228/81 08 765


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


    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. Juni 2007

    Medicines for children - Regulation on medicines for paediatric use EC No 1901/2006
    Dr. Julia Dunne, MHRA, London

    The New Paediatric Regulation - Establishment and Role of the Paediatric Committee (PDCO)
    Dr. Daniel Brasseur, EMEA, London

    Regulation on medicinal products for paediatric use
    RA Burkhard Sträter, Anwaltskanzlei Sträter, Bonn

    The Paediatric Regulation
    Dr. Agnés Saint Raymond, EMEA. London

    Ethical Considerations for Clinical Trials Performed in Children
    Dr. Dirk Mentzer, PEI, Langen

    Special Considerations for Clinical Trials in the Paediatric Population
    Dr. Reinhard Feneberg, Paediatric Unit, KKS Heidelberg

    Vorträge am 13. Juni 2007

    Electronic Regulatory Submission (ERS) in the EU - Overview
    Jörg Schnitzler, Merck Serono, Prof. Dr. Harald G. Schweim, Universität Bonn

    Electronic Regulatory Submission in the EU: Afssaps perspective - France
    Dr. Aziz Diop, afssaps, Saint-Denis

    Electronic Regulatory Submission in the EU - from the Point of view of the NCA
    Dr. Christa Wirthumer-Hoche, AGES PharmMed, Wien

    eWorking at the MHRA - The impact of the Sentinel programme
    Dr. David Wheeler, MHRA, London

    Electronic Regulatory Submission from the Point of View of the National Drug Agencies - Germany
    Dr. Klaus Menges, BfArM, Bonn

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