Fortbildung bei der DGRA e.V.

DGRA-Workshop

GMP/GDP - Good Distribution Practice

16. September 2014 in Bonn

Moderation

Prof. Burkhard Sträter

Termine

Dienstag, 16. September 2014 | 10.00 Uhr bis 05.00 Uhr Termin in den eigenen Kalender übertragen

Veranstaltungsort

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

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  • Programmvorschau Änderungen vorbehalten

    10.00 a.m.

    Keynote speech
    Monitoring of API Good Manufacturing Practice in third countries by EDQM and EMA - requirements and international collaboration

    Dr. Florence Benoit-Guyod, Head of Inspection Team EDQM
       

    11.00 a.m.

    		 Coffee break
       

    11.30 a.m.

    		 Monitoring the importing of medicinal products from third countries
    • Requirements of the import permit in accordance with Section 72 AMG
      1. Local inspections
      2. Repeat testing in the EU
      3. Active Substances

    Tobias Könnecke, District Government of Darmstadt
       

    12.15 p.m.

     GMDP databases at the EMA and at DIMDI
     Status and maintenance

    Prof. Burkhard Sträter and Dr. Susanne Quellmann
       

    1.15 p.m.

    		 Lunch
       

    02.30 p.m.

    Monitoring of the distribution and transport by wholesalers and
    intermediaries in the EU

    • GDP

    Christian Wolf, arvato Healthcare
       

    3.15 p.m.

    		 Ensuring GMP compliance for active pharmaceutical ingredients (APIs) imported to the European Union
    • API import to EU – why significantly regulated?
    • Role of the finished product manufacturer in assessing GMP compliance of APIs
    • Current API import legislation in EU including GMP requirements – Consequences of Falsified Medicines Directive
    • Comparison to EU: Legislation on API import in selected non-EU countries
    Dr. Darius-Jean Namdjou, Grünenthal
       

    04.00 p.m.

    		 Coffee break
       

    04.30 p.m.

    Consequences of GMP deficiencies for marketing authorisations


    Ralf Rest, BfArM
       
    Ca. 5:00 p.m. End
    (Programme subject to change without prior notice)

  • Kostenbeitrag und Stornierungen

    For DGRA members and M.D.R.A. students course XIV / XV: € 250
    (The Casino/canteen is open for lunch -not included)

    Up to two weeks before the first day of the conference (Sept. 2nd, 14): € 50;
    up to one week before the first day of the conference (Sept. 9th, 14): 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
    With the cooperation of DGRA e.V. and the Deutsche Bahn you travel relaxed and comfortably to your DGRA education and training events in 2014. The price for your ticket for a return trip to Bonn is 99 € (2nd class) and 159 € (1st class). Detailed information and booking options for this offer can be found here.

     

    A limited number of rooms are available for participants at special rates in the hotels listed below. When making reservations (up to 4 weeks before the workshop) please refer to  "DGRA".

    • Hotel Königshof, Bonn-City
      Phone: 0049- 228/26010
    • Hotel Maritim, Bonn
      Phone.: 0049 – 228/ 8108-0
    • Hotel Residence, Bonn-City
      Phone: 0049 - 228/2697703
    • Villa Godesberg, Bonn-Bad Godesberg
      Phone: 0049 - 228/830060

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

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