Fortbildung bei der DGRA e.V.


Clinical Trial Applications

11. November 2013 in Bonn


Montag, 11. November 2013 | 10.00 Uhr bis 17.00 Uhr Termin in den eigenen Kalender übertragen


Wissenschaftszentrum Bonn
Ahrstraße 45, 53175 Bonn
Tel.: 0228 - 30 20

  • Programmvorschau Änderungen vorbehalten

    Programm am 11. November 2013

    10.00 I. Clinical Trial Applications in the EU
    • Changes proposed by the Draft Regulation on Clinical Trials
    • Experience with Voluntary Harmonization Procedure (VHP) and Comparison with the future process according to the Draft Regulation
    PD Dr. Thomas Sudhop, Bonn
    11.00 Coffee Break
    11.30 II. Legal Aspects and hot topics linked to Clinical Trials in Europe
    • New types of clinical studies, e.g. PAES/PASS (Post Authorization Efficacy/Safety Studies): Legal definitions and what to expect in practice
    • Ethics Committees and their role in the assessment of clinical trial applications
    • Transparency of clinical trial data and legal implications
    • New databases (EudraCT Vol 9, German database acc. to &42(b) AMG and others): What do they have in common? What are the (legal) differences?
    Prof. Burkhard Sträter, Sträter Rechtsanwälte
    11.45 III. The assessment of Clinical Trial Applications at BfArM
    • The current process in the agency
    • How will the new Regulation be implemented?
    • Frequently asked questions in CTA assessment
    • Statistics on CTAs at BfArM
    PD Dr. Thomas Sudhop, Bonn
    13.00 Lunch Break
    14.00 IV. The position of German Ethics Committees on the proposed Draft Regulation
    • Appreciation and Achievements
    • Major Criticisms and flaws of the draft proposal
    • Assessment of the proposal of the European Parliament
    • Suggestions of the German Ethics Committees

    Prof. Dr. Jörg Hasford, Arbeitskreis Medizinischer Ethikkommissionen

    14.45 V. Practical Aspects of the proposed Draft Regulation
    • Comparison to requirements in other global regions and resulting problems
    • Current and future requirements of CT Registries (EudraCT, etc.): What is the added value for the public and how to cope from a sponsors point of view
    • Streamlined communication with national Competent Authorities in multi center trials
    Dr. Ingrid Klingmann, Pharmaplex bvba
    15.30 Coffee Break
    16.00 VI. The pharmaceutical industries position on the proposed Draft Regulation
    • State of play at the European Parliament
    • What would help pharmaceutical industry to consider Europe for Clinical Trials now and in the future
    Sabine Atzor, Roche
    16.45 VII. Questions and Answers
      all speakers and participations
    17.00 End


  • Kostenbeitrag und Stornierungen

    For DGRA members and M.D.R.A. students course XIV: € 260,-

    The Casino is open for lunch (not included)

    • Up to two weeks before the first day of the conference (28.-Oct.-13): € 50
    • Up to one week before the first day of the conference (4 Nov.-13): 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 (up to 6 weeks before the workshop) please refer to DGRA.

    Hotel Königshof, Bonn-Innenstadt
    Tel.: 0228/26010

    Villa Godesberg, Bad Godesberg
    Tel.: 0228/830060

    Hotel Bristol, Bonn-Innenstadt
    Tel.: 02 28 - 26 98-0

    Maritim Hotel, Bonn
    Tel.: 02 28 -8108872

    More available rooms for direct booking,

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