Fortbildung bei der DGRA e.V.
26. September 2013 in Langen
Donnerstag, 26. September 2013 | 09.30 Uhr bis 17.00 Uhr Termin in den eigenen Kalender übertragen
Paul-Ehrlich-Straße 51-59, 63225 Langen
Tel.: 06103 77 0
Programmvorschau Änderungen vorbehalten
Programm am 26. September 2013
9.30 I. Overarching Guideline - the concept of a “Biosimilar medicinal product”
- Revision of “Guideline on similar medicinal products”
- Selection of reference products
Former Chair of the Biosimilar Medicinal Products Working Party (BMWP) EMA
10.30 Coffee Break 11.00 II. From Comparability to Biosimilarity – quality aspects
- Requirements of quality dossiers
- Comparative characterization – which differences are acceptable?
Expert Pharmaceutical Biotechnologie
11.45 III. Development of biosimilar products from the substance category of monoclonal antibodies
- Non-clinical aspects
Expert of the Biosimilar Medicinal Products Working Party (BMWP) EMA
12.30 Lunch Break 13.30 IV. The experience with biosimilars - how does it influence the current clinical requirements
- Acceptance of surrogate parameters with regard to efficacy
- Patient population in pivotal studies
Member of the Biosimilar Medicinal Products Working Party (BMWP) EMA
14.15 V. Industrial perspective and experience
- Sandoz Biosimilar experience and concepts
- Technical versus Clinical development
- Challenges encountered
- Harmonization between regulatory jurisdictions
- Pharmacovigilance and risk management
- Education of medical community
Dr. Pascale Burtin, Sandoz
15.00 Coffee Break 15.30 VI. Traceability, substitution, impact on Reimbursement financed by the German Statutory Health Insurance System (GKV)
- Identification of products in ADR reporting - requirements acc. Art. 102
- Additional monitoring black triangle for biosmimilars?
16.15 VII. Panel discussion all speakers and participations all speakers and participations 17.00 End
Kostenbeitrag und Stornierungen
For DGRA Members and students of M.D.R.A. Course 14/15: € 270 ,-
The Casino near by (DFS Deutsche Flugsicherung - German Air Traffic Services) is open for lunch (not included).
- Up to two weeks before the first day of the conference (September 12,-2013): € 50
- Up to one week before the first day of the conference (September 19, 2013): 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 please refer to this event.
Hotel Steigenberger, Langen
Phone: 0049 - 06103 - 9720
Unterlagen Mitgliedern vorbehalten