Fortbildung bei der DGRA e.V.

DGRA-Schools

3rd School Clinical Documenation

2. - 3. November 2020

Moderation

Dr. Ingrid Klingmann

Termine

Montag, 2. November 2020 | 09.00 Uhr bis 17.30 Uhr
Dienstag, 3. November 2020 | 09.00 Uhr bis 17.30 Uhr Termin in den eigenen Kalender übertragen

Veranstaltungsort

Online Veranstaltung


  • Programmvorschau Änderungen vorbehalten

    Program November 2nd, 2020

    9.00 a.m.

    I. Introduction to the Clinical Drug Development Process Leading to the Label
    Dr. Ingrid Klingmann

       
    9.45 a.m. Bio break
       
    9.55 a.m.

    II. Basics of Clinical Trials Phase I to IV
    Dr. Ingrid Klingmann

       
    10.40 a.m

    Coffee break

       
    11.00 a.m.

    III. Informed Consent Process and Data Protection
    Dr. Ingrid Kllingmann

       
    11.40 a.m.

    Bio break

       
    11.50 a.m. IV. Ethical Review Process for Clinical Trials in Europe
    Dr. Ingrid Klingmann
       
    12.30 p.m. Lunch
       
    1.30 p.m. V. Good Clinical Practice 
    Dr. Martin Coenen
       
    2.15 p.m. Bio break
       
    2.25 p.m. VI. Management of Trial Documents: from Essential Documents to Trial Master File
    Dr. Martin Coenen
       
    3.30 p.m. Coffee break 
       
    4.00 p.m.

    Quality Management in Clinical Trials
    Dr. Klaus Eckhardt

       
    4.45 p.m.     Ⅷ. Audits and Inspections
    Dr. Klaus Eckhardt
       
    5.30 p.m. End of Day 1
       

     

    Program November 3rd, 2020

    9.00 a.m. Ⅸ. Safety Data Collection and Assessment
    PD Dr. Thomas Sudhop
       
    9.40 a.m. Bio break
       
    9.50 a.m.

    Ⅹ. Safety Reporting in Clinical Trials
    PD Dr. Thomas Sudhop

       
    10.30 a.m. Coffee break
       
    11.00 a.m.

    Current Clinical Trial Legislation: Directive 2001/20/EC and Commission Directive 2005/28/EC
    Dr. Ingrid Klingmann

       
    12.00 p.m. Bio break
       
    12.10 p.m.    Ⅻ. Clinical Trial Authorisation and Reporting
    PD Dr. Thomas Sudhop
       
    13.15 a.m. Lunch
       
    2.15 p.m. XIII. Upcoming Clinical Trial Legislation: Regulation 536/2014
    Dr. Ingrid Klingmann
       
    2.45 p.m. Bio break
       
    2.55 p.m. XIV. Coordinated Assessment Procedures: from VHP to Pilot Projects
    PD Dr. Thomas Sudhop
       
    3.30 p.m. Coffee break
       
    4.00 p.m. XV. Clinical Development Strategies
    Prof. Dr. Thomas Bieber
       
    5.30 p.m.  End 
       

     (There maybe changes to the program)

  • Kostenbeitrag und Stornierungen

    Participation fees:
    For DGRA members and M.D.R.A. students: 390 €, for non-members: 540 €



    Cancellation will incur a handling fee of 50€.
    In case of short-term cancellation (2 weeks before) 50 % of the registration fee will be charged.
    One week before the event the full fee has to be paid,
    unless a substitute participant (DGRA member) is named.

    In case of cancellation by the organizer, already paid fees will be refunded in full.

  • Anmeldung Mitgliedern vorbehalten
    Bitte melden Sie sich hier mit Ihren Zugangsdaten an und klicken Sie danach erneut auf Anmeldung.
  • Sie haben Fragen? Bitte wenden Sie sich an:

    Charlotte Lorenz
    Geschäftsführerin DGRA

    Telefon: +49 (0) 228 - 368 26 46
    E-Mail:

    Stefanie Bodendorfer
    Assistentin DGRA

    Telefon: +49 (0) 228 - 368 26 46
    E-Mail: