Fortbildung bei der DGRA e.V.

DGRA-Jahreskongress

Jahr 2021

Quelle: WorldCCBonn

13. - 14. September 2021 in Bonn

Moderation

Prof. Dr. Karl Broich
Prof. Dr. Karl Broich
Prof. Burkhard Sträter

Termine

Montag, 13. September 2021 | 09.30 Uhr bis 16.00 Uhr
Dienstag, 14. September 2021 | 09.30 Uhr bis 14.00 Uhr Termin in den eigenen Kalender übertragen

Veranstaltungsort

World Conference Center
Platz der Vereinten Nationen 2, 53113 Bonn
Tel.: +49 (0)228-9267-0
Routenplaner

  • Programmvorschau Änderungen vorbehalten

    The Program on September 13th 2021

    9.30 a.m.      
    Opening of the Annual Congress and introduction to Sessions
      Dr. Ulrich Granzer, Granzer Regulatory Consulting & Services
       
    9.45 a.m.
    EMA: Our Way in Pharmaceutical Strategy and International Collaboration
      Emer Cooke, EMA
       
    10.30 a.m.       EU Regulatory Network: Lessons learned from the Pandemic 
      Dr. Christa Wirthumer-Hoche, Chair of Management Board EMA, Head of the Austrian Medicines and Medical Devices Agency
       
    11.00 a.m.
    Coffee Break
       
    11.30 a.m.
    New Roles in Digitalization, Data Science and Health Care Research
      Prof. Dr. Karl Broich, President BfArM
       
    12.00 p.m.
    Industry Perspective on the Current Regulatory Climate
      Dr. Max Wegner, Bayer AG
       
    12.30 p.m. Panel discussion
       
    12.45 p.m.
    Lunch
       
    1.45 p.m.
    Fighting the Pandemic: Contributions of the PEI
      Prof. Dr. Klaus Cichutek, President PEI 
       
    2.30 p.m.

    Micro RNAs: A new Class of Substances for the Therapy of Diseases

      Prof. Dr. Dr. Thomas Thum, Cardior
       
    3.15 p.m.
    EU-HTA-Regulation
    - Status of Procedure – German Positions and Initiatives
      Dr. Lars Nickel, BMG
       
    3.45 p.m. HTA meets Regulatory Affairs
      Dr. Anna Silke Hammerbacher, Daiichi-Sankyo Europe GmbH
       
    4.15 p.m. Panel discussion
       
    4.30 p.m.
    Coffee Break
       
    4.45 p.m.
    DGRA General Membership Meeting
      (ends around 5.30 p.m.)
       
    7.00 p.m.
    Pre-dinner Speech
      Reception (6.30 p.m.) and Buffet

     

    The Program on September 14th 2021

    9.30 a.m.
    Award Ceremonies “Walter-Cyran-Medaille” 
       
    10.00 a.m.
    Medical Device Regulation (MDR) – an Update 
      Dr. Rainer Edelhäuser, Director ZLG 
       
    10.45 a.m.

    Digitalisation of the Healthcare System Electronic Product Information (e-PI)
    - Projects on national/European/international level
    - Key Principles for access and dissemination
    - Electronic Paper or Structured information approach

      Dr. Andreas Franken, BAH
       
    11.30 a.m.
    Coffee Break
       
    12.00 a.m.

    Clinical Trial Regulation – an Update
    - Outcomes of Pilot Procedures in BfArM

      PD Dr. Thomas Sudhop, BfArM 
       
    1.00 p.m.
    Panel Discussion
       
    1.30 p.m.
    Lunch
  • Kostenbeitrag und Stornierungen

    Registration fees:

    Participation in face-to-face event:
    For DGRA members: € 680
    For non-members: € 830

    Participation virtual via Zoom:
    For DGRA members: € 300
    For non-members: € 450

    Discount: Registered students of MDRA course and delegates of organizations (Behörden) who are members of the DGRA: € 360 (face-to-face event), € 250 (virtual)

    The registration is binding. After receipt of the registration a written confirmation will be sent.

    A Covid-19 vaccination certificate is required for participation in face-to-face event.

    You want to become a member of the DGRA e.V.?

    Information membership

    Cancellation terms

    Cancellation will be charged with a processing 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 the event of cancellation by the organizer, any fees already paid will be fully reimbursed.

  • Anreise und Unterkunft
     How to find us.

    Room reservation:

    A limited number of rooms are available for participants at special rates in the hotels listed below. When making reservations please refer to “DGRA”/DGRA Annual congress.

    Ameron Königshof
    Bonn-Innenstadt
    reservierung@hotel-koenigshof-bonn.de
    keyword „DGRA120921“

    Boutiquehotel Dreesen GmbH & Co.KG
    Mirbachstrasse 2a
    53173 Bonn
    info@boutiquehoteldreesen.de

    Rheinhotel Dreesen
    Bonn-Bad Godesberg
    reservierung@rheinhoteldreesen.de
    keyword “DGRA-Jahreskongress”

    Intercity Hotel
    Bonn-Innenstadt
    reservations.bonn@intercityhotel.com
    Keyword „DGRA“

    More hotel rooms can be booked directly on the internet:
    https://www.bonn-region.de/events/dgra2021.html
    Each participant booking her/his room via the above link of the Tourismus & Congress GmbH will receive a Congress ticket in PDF format with the booking confirmation.
    This entitles the participants to use the bus line SB 60 from Airport Cologne / Bonn to Bonn Hbf, the train line 66 from the ICE station Siegburg - Bad Honnef, and other buses and trains within the city of Bonn on arrival and departure day. In addition, participants can use the local public free of charge with the Congress ticket during the Congress in the area of Bonn, Cologne, St. Augustin , Siegburg and Königswinter (Verkehrsverbund Rhein Sieg Area).

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

    Documentation 13th 

    Our Way in Pharmaceutical Strategy and International Collaboration
    (Emer Cooke)

    Download Präsentation (PDF | 1 MB)


    EU Regulatory Network: Lessons learned from the Pandemic  
    (Dr. Christa Wirthumer-Hoche)

    Download Präsentation (PDF | 1.3 KB)


    New Roles in Digitalization, Data Science and Health Care Research
    (Prof. Dr. Karl Broich)

    Download Präsentation (PDF | 4,3 KB)


    Industry Perspective on the Current Regulatory Climate
    (Dr. Max Wegner)

    Download Präsentation (PDF | 1,5 KB)


    Fighting the Pandemic: Contributions of the PEI
    (Prof. Dr. Klaus Cichutek)

    Download Präsentation (PDF | 18 MB)


    Micro RNAs: A new Class of Substances for the Therapy of Diseases
    (Prof. Dr. Dr. Thomas Thum)

    Download Präsentation (PDF | 4 KB)


    EU-HTA-Regulation
    (Dr. Lars Nickel)

    Download Präsentation (PDF | 1,7 KB)


    HTA meets Regulatory Affairs
    (Dr. Anna Silke Hammerbacher)

    Download Präsentation (PDF | 1 KB)

     


    Documentation14th 

    Medical Device Regulation (MDR) – an Update
    (Dr. Rainer Edelhäuser)

    Download Präsentation (PDF | 1 MB)


    Digitalization of the Healthcare System Electronic Product Information (e-PI)
    (Dr. Andreas Franken)

    Download Präsentation (PDF | 3.2 MB )


    Clinical Trial Regulation – an Update
    (PD Dr. Thomas Sudhop)

    Download Präsentation (PDF | 650 KB)

     

     

     

  • Sie haben Fragen? Bitte wenden Sie sich an:

    Charlotte Lorenz
    Geschäftsführerin DGRA

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