Available as an in-house course

An Integrated Approach to Pharmacokinetics in Drug Development

Course Dates

18 June 2008

Venue

The Baltic Exchange, 38 St Mary Axe, London EC3A 8BH

Cost

£500.00 + VAT £87.50    Total £587.50

Overview

The course objective is to provide participants with an overview of the principles of pharmacokinetics (PK) and of pharmacokinetic/pharmacodynamic (PKPD) modelling and how they fit together with the drug regulatory environment.

This new course provides participants with an integrated overview of pharmacokinetics in drug development.  Pharmacokinetic terms will be explained and factors contributing to their variability will be discussed.  How emerging data and the regulatory environment influence PK strategy will be covered through the use of examples from the literature and the speaker's own experience.  Drug interaction, bioavailability (including inhaled compounds) and first in man studies will be considered.  In addition the place PKPD modelling and simulation (including population pharmacokinetics) in drug development will be presented.  Delegate's knowledge will be further enhanced through participation in break out sessions where practical exercises and case histories will be examined.

Who will benefit from the course

The course is intended for all professionals in the drug development arena especially those that work in or with clinical project teams (eg Regulatory Affairs specialists; Project managers/leaders; Clinical research associates) who want to further their knowledge of the usefulness of PK in their projects.

At the end of the course participants will have an

• Understanding of the common pharmacokinetic terms and their importance
• Understanding of how PK data influences the clinical development programme
• Insight into the factors that contribute to variability in PK
• Understanding of the role of PKPD modelling in drug development
• An appreciation of how regulatory guidances influence PK strategy

Programme

9.00     Introductions

9.10     What is PK and why is it important?

9.50     Pre-clinical/clinical interface

10.30   coffee

11.00   Factors influencing PK variability

12.10   Exercise

12.30   Lunch

1.30     Bioavailability and Bioequivalence

2.15     PKPD Modelling and simulation

3.00     Coffee

3.30     Case Study

4.30     Summary and questions

4.45     Close

Participants will need to bring along a scientific calculator

Course Speaker

Dr Graham Blakey,  GBPK Consulting. Graham  graduated with a BSc (Hons) degree in Pharmacy before undertaking various roles in hospital pharmacy. He gained an MSc in Clinical Pharmacology from the University of Glasgow. This experience developed Graham's interest in pharmacokinetics and lead to a PhD with Prof Malcolm Rowland at the University of Manchester. His thesis was entitled 'Tissue kinetics of a series of barbiturates'.

Graham spent 12 years with AstraZeneca Charnwood where he held several roles including Principal Scientist and Head of Clinical Pharmacokinetics.  During this time he gained extensive experience in providing clinical pharmacology strategy including pharmacokinetic/pharmacodynamic input and analysis to all phases of clinical drug development. Graham has worked in many global project teams, as a clinical pharmacokineticist and project leader, in several therapeutic areas including: inflammation, cardiovascular and CNS. Output from these teams has supported drug development in Europe, Japan and North America.

Graham has a particular interest in the determination of clinically relevant drug drug interactions. Throughout his career he has pioneered the use of probe drugs (including the cocktail approach) as clinical markers of the activity of the Cytochrome P450 drug metabolising isoenzymes.  His work in inflammation centred on rheumatoid arthritis and osteoarthritis and saw several novel compounds progress from pre-clinical to patient studies.  Graham now works in consultancy providing clinical pharmacology and pharmacokinetic expertise to the pharma industry.

Terms and conditions

Delegate fees

Fees for this programme are shown overleaf. Delegate fees are inclusive of course documentation, refreshments and lunch as well as course dinner.

Payment  of the registration fee must be paid within 14 days  of commencement of the course.  Upon receipt of payment, a proof of payment will be sent to you.

Cancellation Policy

Full refunds less a handling fee of £100 will be made for cancellations received in writing within 28 days of the commencement of the course.

Refunds of 50% will be made for cancellations received in writing between 28 and 7 days prior to the commencement of the course. 

Regrettably no refunds will be made after 7 days prior to commencement of the course.

Substitutions can be made at any time.

Liability

PharmaTrainingServices reserves the right to change the Programme, speakers, date or venue without notice or cancel The event.  If cancellation occurs delegates will be notified as soon as possible and will receive full refund of fees paid. 

PharmaTrainingServices will not be responsible for any airfare, accommodation  or other travel costs incurred.