New Strategies for the development of New Molecular Entities

DGRA-Workshop

Dr. rer. nat. Ulrich Granzer

Mittwoch, 27. Februar 2008 | 09.30 Uhr bis 16.00 Uhr Termin in den eigenen Kalender übertragen

Wissenschaftszentrum Bonn
Ahrstraße 45, 53175 Bonn
Tel.: 0228 - 30 20
Routenplaner

	Programm am 27. Februar 2008

09.30	Introduction: New Strategies for the development of New Molecular Entities
	Why are they necessary? Which trends and new ideas are being intorduced? Dr. U. Granzer, Granzer Regulatory Consulting and Services, Munich

10.00	The role of biomarkers and surrogate parameters in the development of new drugs
	Dr. Steffen Bassus, PEI, Langen Prof. Dr. Wolfgang Meyer-Sabellek, AstraZeneca, Bruxelles

10.45	Coffee Break

11.15	Phases in clinical trials, are they outdated?
	Pre-Phase I developments: Earlier into man? Dr. Ian Hudson, MHRA, London PD Dr. Michael Kirchengast, Pharmaceutical Research Associates GmbH,Mannheim
	Adaptive designs to combine clinical development phases Dr. Peter Volkers, PEI, Langen Dr. Martin Krauss, FGK, Munich

12.30	Discussion

13.00	Lunch

14.00	Interaction between Industry and Regulatory Authorities, new ways for drug approvals
	Translational medicine and critical path initiative of FDA Dr. U. Granzer, Granzer Regulatory Consulting and Services, Munich

	New ways to obtain an early approval: Conditional approval: Approval under exceptional circumstances; compassionate use programmes Dr. Birka Lehmann, BfArM, Bonn Dr. ChristineMayer-Nicolai, Merck Serono, Darmstadt

15.30	Discussion

16.00	End