Risk Management

DGRA-Workshop

Prof. Burkhard Sträter

Mittwoch, 7. November 2007 | 09.30 Uhr bis 17.30 Uhr Termin in den eigenen Kalender übertragen

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

	Programm am 7. November 2007

9.30	Needs and expectations on Risk Management Plans from a regulatory perspective
	Prof. Ingemar Persson, MPA, Uppsala

10.00	How can Agencies and Industry ensure that one EU RMP is acceptable in all Member States
	and within a global context?
	Afssaps experience and internal organisation Dr. Anne Castot, Afssaps, Saint-Denis Risk Management during product development and life cycle Dr. Barry Arnold, AstraZeneca, Cheshire

11.00	Coffee Break

12.00	BfArM experiences in assessment of RMP
	Dr. Ulrich Hagemann, BfArM, Bonn
	Special paediatric perspectives in assessment of RMP Dr. Dirk Mentzer, PEI, Langen

12.30	Lunch

13.30	Further defining post authorisation safety studies: their role in the EU RMP
	Company perspective Dr. Janet Hormbrey, MSD Inc., Brussels Agency perspective Prof. Ingemar Persson, MPA, Uppsala

14.30	The value of pharmacoepidemiology studies
	Cohort follow-up and case-control studies Prof. Edeltraut Garbe, BIPS, Bremen Spontaneous reporting – randomized studies – drug application research Prof. Joerg Hasford, University of Munich

15.30	Coffee Break

16.00	National Risk Minimisation Plans – what are typical measures?
	Assessment of educational material Dr. Ulrich Hagemann, BfArM, Bonn Possible answers to risk management questions Prof. Barbara Sickmüller, BPI, Berlin

17.00	Panel discussion with Speakers

17.30	End