Fortbildung bei der DGRA e.V.


Jahr 2014

Bildquelle: WorldCCBonn

8. - 9. Mai 2014 in Bonn


Rechtsanwalt Prof. Burkhard Sträter
Prof. Burkhard Sträter


Donnerstag, 8. Mai 2014 | 09.30 Uhr bis 16.00 Uhr
Freitag, 9. Mai 2014 | 09.30 Uhr bis 14.00 Uhr
Mitgliederversammlung 08. Mai 2014 um 16.00 Uhr
Abendessen in der Godesburg 08. Mai 2014 um 19.00 Uhr Termin in den eigenen Kalender übertragen


Wasserwerk Bonn
Hermann-Ehlers-Straße Eingang V, 53113 Bonn
Tel.: +49 (0)228 / 92 67 - 0

  • Programmvorschau Änderungen vorbehalten
      The Program on May 8, 2014
    9.30 am Opening of the Annual Congress and introduction to sessions,
    Dr. Ulrich Granzer
    9.45 am I. Joint Scientific Advice (JSA) - BfArM G-BA
    • Endpoints, Biomakers, Surrogat Endpoints, Comparative Therapy
    • Procedures of BfArM - Routine or Exception?
    Prof. Dr. Karl Broich, Vice President BfArM
      II. JSA in Germany with BfArM/PEI and G-BA
    • Joined Scientific Advice by G-BA with BfArM and PEI
    • Right Time in Product Development
    • Level of Commitment of the Early Benefit Assessment
    • Participipation of the G-BA in Scientific Advice Pilots at European Level
    Thomas Müller, head of department “Medicinal products” Federal Joint
    Committee G-BA
    11.00 am Coffee break
    11.30 am III. National Review from the perspective of the pharmaceutical industry
    • Experiences with early G-BA advice and involvement of BfArM/PEI
    • Procedure of National Scientific Advice with G-BA

    Dr. Anja Langeneckert, Head of Regulatory Affairs, Roche Pharma


    IV. Parallel Scientific Advice by EMA with MAHs and HTAs

    • EMA procedures - Experiences and Outlook
    • Participation of HTA Bodies
    • Assessment of HTA aspects in EPAR
    Dr. Tomas Salmonson, CHMP Chair EMA
    12.15 pm Panel Diskussion
    12.45 pm Lunch break
    14.15 pm V. European Review from the perspective of the pharmaceutical industry
    • Experiences with EMA/HTA Bodies and EUnet/HTA
    • What are the industrial expectations?
    • What is realistic? What is desirable?
    Britta Paschen, Vice President Health Services Research, Merck KG aA
    14.45 pm Panel Discussion with all speakers
    15.00 pm “Walter-Cyran-Medaille” award
    15.30 pm Coffee break
    16.00 pm DGRA Members’ Meeting
    (ends at around 6.00 pm)
    19.00 pm Pre-dinner Speech
    Reception and buffet
      The Program on May 09, 2014
    9.30 am “DGRA-Förderpreis“ award
    10.00 am

    VI. Pharmacovigilance Update Europe

    • EU Risk Management Plan (RMP)/Risk Minimisation Measures
    • PASS (Post Authorisation Safety Studies)
    • Medication Errors / Off Lable Use
    • Paediatric Pharmacovigilance

    Dr. Dirk Mentzer, PEI, PDCO Chair

    11.00 am Coffee break
    11.30 am VII. National Pharmacovigilance Update
    • Adverse Drug Reactions (ADRs) reporting (nue EMA Business rules in accordance with E2B (R3))
    • PSURs, PSUR repository
    • Implementation of PRAC Decisions during the signal procedure
    • AWB: Announcement and database
    • News in the Development of MedDRA: Results of Blue Ribbon Panel of MSSO
    Dr. Norbert Paeschke, Head of Pharmacovigilance BfArM
    12.15 pm VIII. Review from the perspective of the pharmaceutical industry
    Dr. Ulrich Granzer, Munich
    13.00 pm Panel Discussion with all speakers
    13.15 pm Lunch / Snack


  • Kostenbeitrag und Stornierungen

    For DGRA members: € 460,-
    For non-members: € 590,-

    Student price: Students of DRA course (MDRA XI) and delegates of bodies (Behörden) who are members of the DGRA: € 260,-

    Sie möchten Mitglied in der DGRA e.V. werden?

    Informationen zur Mitgliedschaft

    Cancellation terms

    Up to two weeks before the first day of the conference (24-April-2014): € 50;
    up to one week before the first day of the conference (01-May-2014): 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 please refer to this event.

    Hotel (Günnewig) Bristol
    Prinz-Albert-Strasse 2
    D-53113 Bonn
    Tel.: +49(0)228 / 26 98-0
    Fax: +49(0)228 / 26 98-2 22

    Markt 8
    D-53111 Bonn
    Tel.: +49(0)228 / 72 67-0
    Fax: +49(0)228 / 72 67-125

    Hotel (Günnewig) Residence
    Kaiserplatz 11
    D-53113 Bonn
    Tel: +49(0)228 / 26 97-0
    Fax: +49(0)228 / 26 97-777

    Hotel Hilton
    Berliner Freiheit 2
    53111 Bonn
    Tel: +49(0)228 / 72 69-0
    Fax: +49(0)228 / 72 69-700

    Hotel Maritim
    Godesberger Allee
    53175 Bonn
    Tel.: +49(0)228 / 81 08-0
    Fax: +49(0)228 / 81 08-811

    Villa Godesberg
    Mirbachstrasse 2a
    53173 Bonn - Bad Godesberg
    Tel.: 0228 / 83 00 6-0
    Fax: 0228 / 83 00 6-90

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

    Presentations on May 08, 2014

    Joint Scientific Advice - Interaction of BfArM and G-BA
    Prof. Dr. Karl Broich, Federal Institute for Drugs and Medical Devices (BfArM), Bonn

    JSA in Germany with BfArM/PEI and G-BA
    Thomas Müller, Federal Joint Committee (G-BA), Berlin

    Experiences with early G-BA advice and involvement of BfArM/PEI
    Dr. Anja Langeneckert, Roche Pharma AG, Grenzach

    Parallel Scientific Advice By EMA with MAHs & HTAs
    Tomas Salmonson, European Medicine Agency (EMA), London

    European Review from the Perspective of the Pharmaceutical Industry
    Britta Paschen, Merck KGaA, Darmstadt

    Presentations on May 09, 2014

    "DGRA-Förderpreis" award
    Project-, Drug-, and Business Development in a Biotech SME
    Dr. Christian Hanke

    Pharmacovigilance Update Europe
    Dr. Dirk Mentzer, Paul-Ehrlich-Institut (PEI), Langen

    National Pharmacovigilance update
    Dr. Norbert Paeschke, Federal Institute for Drugs and Medical Devices (BfArM), Bonn

    PRAC Experience
    Dr. Ulrich Granzer, Granzer Consulting, München