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DGRA-Schools

2. DGRA-School | Clinical Documentation

25. - 26. Oktober 2011 in Bonn

Termine

Dienstag, 25. Oktober 2011 | 09.00 Uhr bis 17.00 Uhr
Mittwoch, 26. Oktober 2011 | 09.00 Uhr bis 17.15 Uhr Termin in den eigenen Kalender übertragen

Veranstaltungsort

Hotel Bristol
Prinz-Albert-Straße 2, 53113 Bonn
Tel.: 0228 - 26 98-0
Routenplaner

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  • Programmvorschau Änderungen vorbehalten
     

    Programm am 25. Oktober 2011
       
    9.00 Introduction to Clinical Drug Development Process and Basics of Clinical Trials Phase I to IV
      Dr. I. Klingmann
       
    10.30 coffee break
       
    11.00 Ethical Review, Ethics Committees and Informed Consent Process
      Dr. B. Wilffert
       
    12.30 lunch
       
    13.30 Good Clinical Practice and Essential Documents
      Dr. B. Wilffert
       
    15.30 coffee break
       
    16.00 European and German Clinical Trials Legislation
      Dr. I. Klingmann
       
    17.00 end
       
       
     

    Programm am 26. Oktober 2011
       
    9.00 Safety in Clinical Trials
     
    • AEs/SAEs/SUSARs – Annual Safety Report – EudraVigilance – Risk-/ Benefit Analysis – 14. AMG Novella
    Dr. Th. Sudhop
       
    11.00 coffee break
       
       
    11.30 Quality Management in Clinical Trials: from SOPs to Inspections
      Dr. I. Klingmann
       
    12.45 lunch
       
    13.45 Clinical Trials in Vulnerable Populations – Women, Elderly, Children
      Dr. Th. Sudhop
       
    15.15 coffee break
       
    15.45 Clinical Section of the Application Dossier, SPC and EPAR
      Dr. C. Arras-Reiter
       
    17.15 end
       

    Anfahrtskizze zum Hotel Bristol, Bonn

  • Kostenbeitrag und Stornierungen

    For DGRA members and M.D.R.A. students course XIII: € 750,-

    • Up to two weeks before the first day of the conference(October 11, 2011): € 50,-
    • Up to one week before the first day of the conference (October 18, 2011): 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

    A limited number of rooms are available for participants at special rates in the hotels listed below. When making reservations please refer to „DGRA“.

    Hotel Bristol, Bonn
    phone: 0049 –228 – 26980

    Hotel Königshof, Bonn
    phone: 0049 –228 – 26010

    More available rooms for direct booking
    www.bonnhotels.de (incl. public transport),
    www.hrs.de

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