Fortbildung bei der DGRA e.V.
13. September 2011 in Bonn
Dienstag, 13. September 2011 | 10.00 Uhr bis 16.30 Uhr Termin in den eigenen Kalender übertragen
Ahrstraße 45, 53175 Bonn
Tel.: 0228 - 30 20
Programmvorschau Änderungen vorbehalten
Programm am 13. September 2011
10.00 I. 15-years EMA experience in Oncology: Guidance – Products – Endpoints
- Current body of EMA Guidance and future evolution. Revised Guidance “Evaluation of anticancer medicinal products in man” (2011) including appendixes on ‘Methodological issues related to progression-free survival’ (2008), ‘Haematological malignancies’ (2010) and addendum on ‘Paediatriconcology’ (2004). ‘Note for Guidance on non-clinical evaluation for anticancer pharmaceuticals’ (ICH S9) (2010)
- EMA experience with oncology drugs 1995-2011: trends and shifts. ‘Personalized medicines’ in oncology – myth or reality?
- EMA viewpoint on the use of surrogate endpoints in the cancer setting. Will ‘targeted therapies’ impact on EMA’s viewpoint?
10.45 Coffee Break 11.15 II. Assessment of new applications and type II variations in the cancer setting: The Regulators’ experience
- Beyond the Common Technical Document: Avoiding pitfalls in Art 8.3 and type II variation dossiers for cancer products
- CMC aspects and patterns regarding type I variations for marketed oncology products: do they work like other medicinal products?
- Risk-benefit assessment of oncology products: any particularities in the evaluation of cancer medicines?
11.45 III. Highly innovative medicinal products: how to successfully develop biologicals in oncology
- ‘State-of-the-art’ assessment of immunogenicity for innovative biologicals
- Specific considerations for the early clinical testing – did the 2007 Guideline for ‘first-in-man clinical trials for potential high-risk medicinal products’ deliver?
12.30 Lunch Break 13.30 IV. Global development of new cancer medicines: achievements, hurdles and gaps in the regulatory framework
- Product approval patterns in the EU and US and Japan: similar, but not identical
- Achievements, hurdles and unfilled gaps in the regulatory harmonization of oncology drug product development
- Developing personalized medicines globally: lessons to learn how to integrate emerging regions into the clinical development
14.15 Coffee Break 14.45 V. Pre-and post-approval studies in hematology and oncology: The Investigator’s perspective
Prof. Dr. Lothar Bergmann, University Hospital Frankfurt
15.30 VI. Concluding discussion of the panel all speakers and participants
Kostenbeitrag und Stornierungen
For DGRA members and M.D.R.A. students course XII: € 250,-
The Casino is open for lunch (not included)
- Up to two weeks before the first day of the conference(30-Aug-11): € 50
- Up to one week before the first day of the conference (6-Sep-11): 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(up to August 15) please refer to DGRA.
Hotel Bristol, Bonn-Innenstadt
Phone: +49 - 228/269 88 49
Hotel Stern, Bonn-Innenstadt
Phone: +49 - 228 /72 67 0
More available rooms for direct booking
www.bonnhotels.de (incl. public transport), www.hrs.de
Unterlagen Mitgliedern vorbehalten