8:45am
Registration
9am
Welcome
Susan Cole, Expert Pharmacokinetics Assessor, MHRA
David Brown, Expert Statistical Assessor, MHRA
9:10am
Overview of 5 years of scientific advice and PK major objections
Justin Pittaway-Hay, Pharmacokinetics Assessor, MHRA
9:40am
Requirements for clinical pharmacokinetics dossiers
Susan Cole, Expert Pharmacokinetics Assessor, MHRA
10:30am
Refreshments
10:45am
Drug interactions
Nicole Assmann, Medical Assessor, MHRA
11:30am
PBPK - overview, reporting and qualification
Susan Cole, Expert Pharmacokinetics Assessor, MHRA
12:30pm
Lunch break
1:15pm
Considerations for clinical PK in paediatrics/extrapolation
Justin Pittaway-Hay, Pharmacokinetics Assessor, MHRA
2pm
Dose-exposure-response analyses
Essam Kerwash, Pharmacokinetics Assessor, MHRA
2:45pm
Refreshments
3pm
PK requirements for special populations
Paola Coppola, Pharmacokinetics Assessor, MHRA
3:30pm
Population PK - overview, reporting
Essam Kerwash, Pharmacokinetics Assessor, MHRA
4:15pm
Q&A and closing comments
4:30pm
End