Fortbildung bei der DGRA e.V.



26. September 2013 in Langen


Dr. rer. nat. Ulrich Granzer
Dr. rer. nat. Ulrich Granzer


Donnerstag, 26. September 2013 | 09.30 Uhr bis 17.00 Uhr Termin in den eigenen Kalender übertragen


Paul-Ehrlich-Straße 51-59, 63225 Langen
Tel.: 06103 77 0

  • Programmvorschau Änderungen vorbehalten

    Programm am 26. September 2013

    9.30 I. Overarching Guideline - the concept of a “Biosimilar medicinal product”
    • Revision of “Guideline on similar medicinal products”
    • Selection of reference products
    Dr. Pekka Kurki, Finnish Medicinces Agency,
    Former Chair of the Biosimilar Medicinal Products Working Party (BMWP) EMA
    10.30 Coffee Break
    11.00 II. From Comparability to Biosimilarity – quality aspects
    • Requirements of quality dossiers
    • Comparative characterization – which differences are acceptable?
    Dr. Brigitte Brake, Bonn
    Expert Pharmaceutical Biotechnologie
    11.45 III. Development of biosimilar products from the substance category of monoclonal antibodies
    • Non-clinical aspects
    Dr. Gabriele Reichmann, Langen
    Expert of the Biosimilar Medicinal Products Working Party (BMWP) EMA
    12.30 Lunch Break
    13.30 IV. The experience with biosimilars - how does it influence the current clinical requirements
    • Acceptance of surrogate parameters with regard to efficacy
    • Patient population in pivotal studies
    Dr. Marie-Christine Bielsky, MHRA UK
    Member of the Biosimilar Medicinal Products Working Party (BMWP) EMA
    14.15 V. Industrial perspective and experience
    • Sandoz Biosimilar experience and concepts
    • Technical versus Clinical development
    • Challenges encountered
    • Harmonization between regulatory jurisdictions
    • Pharmacovigilance and risk management
    • Education of medical community

    Dr. Pascale Burtin, Sandoz

    15.00 Coffee Break
    15.30 VI. Traceability, substitution, impact on Reimbursement financed by the German Statutory Health Insurance System (GKV)
    • Identification of products in ADR reporting - requirements acc. Art. 102
      (Directive 2001/83)
    • Additional monitoring black triangle for biosmimilars?
    Prof. Burkhard Sträter, Kanzlei Sträter
    16.15 VII. Panel discussion all speakers and participations
      all speakers and participations
    17.00 End

  • Kostenbeitrag und Stornierungen

    For DGRA Members and students of M.D.R.A. Course 14/15: € 270 ,-

    The Casino near by (DFS Deutsche Flugsicherung - German Air Traffic Services) is open for lunch (not included).

    • Up to two weeks before the first day of the conference (September 12,-2013): € 50
    • Up to one week before the first day of the conference (September 19, 2013): 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 this event.

    Hotel Steigenberger, Langen
    Phone: 0049 - 06103 - 9720

    Achat Comfort Hotel, Langen
    Phone.: 0049 – 6103 756 0

    Further hotel reservations can be made directly via internet portals e.g.,

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