Fortbildung bei der DGRA e.V.
DGRA-Jahreskongress
Jahr 2019
23. - 24. Mai 2019 in Bonn
Moderation
Termine
Donnerstag, 23. Mai 2019 | 09.30 Uhr bis 16.00 Uhr
Freitag, 24. Mai 2019 | 09.30 Uhr bis 14.00 Uhr
Mitgliederversammlung 23. Mai 2019 um 16.15 Uhr
Abendessen im Rheinhotel Dreesen am 23. Mai 2019 um 19.00 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 May 23th 2019
9.30 a.m. Opening of the Annual Congress and introduction to Sessions Dr. Ulrich Granzer, Granzer Regulatory Consulting & Services 9.45 a.m. Relocation of EMA, Challenges and Consequences Prof. Guido Rasi - Executive Director EMA 10.30 a.m. Realignment of the EU-network: Perspectives from the Management Board and NCA Dr. Christa Wirthumer-Hoche, Chairman of Management Board EMA, Head of the Austrian Medicines and Medical Devices Agency 11.00 a.m. Coffee Break 11.30 a.m. Impact of the Brexit from an Industrial Perspective Dr. Isabelle Stöckert, Bayer AG 12.00 p.m. HMA / EMA Joint Big Data Task force initiative Presentation of the Report and next steps
Nikolai C. Brun, Chair of joint HMA/EMA Task Force on Big Data, DKMA12.45 p.m. Lunch 1.45 p.m. From Big Data to Real World Data: hype or meaningful for regulators? Prof. Dr. Karl Broich, President BfArM 2.30 p.m. Application of Big Data strategies and technologies in proteomics and individualised therapeutic vaccines Dr. Mark Goldammer, Member of joint HMA/EMA Task Force on Big Data, PEI 3.00 p.m. Clinical Trials: First in men and complex study designs Prof. Dr. Klaus Cichutek, President PEI 3.45 p.m. Panel discussion 4.15 p.m. Coffee Break 4.30 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 May 24th 2019
9.30 a.m. Award Ceremonies “Walter-Cyran-Medaille” and “DGRA-Förderpreis“ 10.00 a.m. Einleitung zu neuen Gesetzgebungsverfahren Prof. Burkhard Sträter, Kanzlei Sträter Rechtsanwälte 10.30 a.m. Die neue Medizinprodukte-Verordnung – aktueller Sachstand Dr. Heike Wollersen, BAH 11.15 a.m Panel discussion 11.30 a.m. Coffee Break 12.00 a.m. Arzneimittelüberwachung, ATMPs und Post-Marketing-Daten: Aktuelle Gesetzesvorhaben Thomas Müller, BMG 1.00 p.m. Panel Discussion 1.30 p.m. Lunch/ Dinner -
Kostenbeitrag und Stornierungen
For DGRA members: € 680,-
For non-members: € 830,-Student price: Registered Students of MDRA course and delegates of bodies (Behörden) who are members of the DGRA: € 360,-
The registration is binding. After receipt of the registration a written confirmation will be sent.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
A limited number of rooms are available for participants at special rates in the hotels listed below. When making reservations please refer to “DGRA” / this event.
Rheinhotel Dreesen
Bonn-Bad Godesberg
Tel.: +49 (0) 228 / 8202-0
info@rheinhoteldreesen.deIntercity Hotel
Bonn-Innenstadt
+49 228 926181-0
reservations@bonn.intercityhotel.deHotel Rheinland Bad Godesberg
Bonn-Bad Godesberg
Tel.: +49 (0) 228 / 82 00 0-0
rezeption@hotel-rheinland-bonn.deHOTEL MYPOPPELSDORF
Bonn-Innenstadt
Tel,: +49 (0) 228 26 910
INFO@MYPOPPELSDORF.COMBonn Marriott Hotel
direkt am Veranstaltungsort
Buchung nur über folgenden Link:
https://www.marriott.com/events/start.mi?id=1551945424992&key=GRP
More hotel rooms can be booked directly on the internet:
https://www.bonn-region.de/events/dgra-jahreskongress-2019.html - Walter-Cyran-Medaille
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Mitgliederversammlung Mitgliedern vorbehalten
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Unterlagen
Relocation of EMA, Challenges and Consequences
Prof. Guido Rasi, Executive Director EMARealignment of the EU-network: Perspectives from the Management Board and NCA
Dr. Christa Wirthumer-Hoche, Chairman of Management Board EMA, Head of the Austrian Medicines and Medical Devices AgencyImpact of the Brexit from an Industrial Perspective
Dr. Isabelle Stöckert, Bayer AGHMA / EMA Joint Big Data Task force initiative
Presentation of the Report and next steps
Nikolai C. Brun, Chair of joint HMA/EMA Task Force on Big Data; DKMA
From Big Data to Real World Data: hype or meaningful for regulators?
Prof. Dr. Karl Broich, President BfArMApplication of Big Data strategies and technologies in proteomics and individualised therapeutic vaccines
Dr. Mark Goldammer, Member of joint HMA/EMA Task Force on Big Data; PEIClinical Trials: First in men and complex study designs
Prof. Dr. Klaus Cichutek, President Paul-Ehrlich-InstitutEinleitung zu neuen Gesetzgebungsverfahren (Unterlagen auf Anfrage)
Prof. Burkhard Sträter, Kanzlei Sträter Rechtsanwälte
Die neue Medizinprodukte-Verordnung – aktueller Sachstand
Dr. Heike Wollersen, BAH
Arzneimittelüberwachung, ATMPs und Post-Marketing-Daten: Aktuelle Gesetzesvorhaben (Unterlagen auf Anfrage)
Thomas Müller, BMG -
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