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Clinical Pharmacokinetics for Regulatory Submissions Masterclass

This event will provide a general update of the current EU regulatory trends in the requirements for pharmacokinetic dossiers and will cover key changes related to the impact of Brexit on clinical pharmacology data requirements and submissions in the UK.

29 Mar 2019

Abstracts deadline:

Registration deadline:

London, UK - View map

  • Overview
  • Event programme

Based on experience assessing numerous marketing authorisation applications and being involved in hundreds of scientific advice applications the MHRA assessors will provide valuable insights for all professionals involved in clinical pharmacology including process development scientists, physicians, pharmacokineticists, statisticians, regulatory affairs staff.

Specific sessions will focus on a number of recurrent issues encountered by the regulators during the evaluation of the pharmacokinetics in applications including discussion of PK major objections and how modelling and simulation can support fast and efficient drug development.

Delegates will have access to assessors and discuss the guidelines and the regulators’ expectations in terms of dossier assembly and data requirements.

Find out more and register.

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