Fortbildung bei der DGRA e.V.
DGRA-Jahreskongress
Jahr 2021
13. - 14. September 2021 in Bonn
Moderation
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
Download
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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 InitiativesDr. 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 approachDr. Andreas Franken, BAH 11.30 a.m. Coffee Break 12.00 a.m. Clinical Trial Regulation – an Update
- Outcomes of Pilot Procedures in BfArMPD 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: € 830Participation virtual via Zoom:
For DGRA members: € 300
For non-members: € 450Discount: 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.?
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
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Mitgliederversammlung Mitgliedern vorbehalten
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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)
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