About

We are pleased to announce the MHRA Masterclass on Clinical Phamacokinetics for Regulatory Submissions. 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.

The 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.

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.

Questions for the panel

Once you have registered, you have the opportunity to submit pre-event questions to our panel of speakers via the Delegate Area. You will be issued with login details on your registration confirmation email. The team will endeavour to answer as many of these questions as they can at the event. Please include in your submission the name of the speaker you wish to address your question to.

To submit your questions, please log into the Delegate Area and go to Panel Questions in the menu.

#PKMasterclass

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Agenda

  • Registration

  • Welcome

  • Overview of 5 years of scientific advice and PK major objections

  • Requirements for clinical pharmacokinetics dossiers

  • Refreshments

  • Drug interactions

  • PBPK - overview, reporting and qualification

  • Lunch break

  • Considerations for clinical PK in paediatrics/extrapolation

  • Dose-exposure-response analyses

  • Refreshments

  • PK requirements for special populations

  • Population PK - overview, reporting

  • Q&A and closing comments

  • End

Speakers

Nicole Assmann photo

Nicole Assmann

Medical Assessor, MHRA

Nicole Assmann is a Medical Assessor at the MHRA. Nicole obt...
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Susan Cole photo

Susan Cole

Expert Pharmacokinetics Assessor, MHRA

Susan Cole is an Expert Pharmacokinetics Assessor and Head o...
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Paola Coppola photo

Paola Coppola

Pharmacokinetics Assessor, MHRA

Paola Coppola is a Pharmacokinetics Assessor at the MHRA. Sh...
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David Brown photo

David Brown

Expert Statistical Assessor, MHRA

David Brown is an Expert Statistical Assessor at the MHRA wh...
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Essam Kerwash photo

Essam Kerwash

Pharmacokinetics Assessor, MHRA

Essam Kerwash is a Pharmacokinetics Assessor at the MHRA. He...
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Justin Pittaway-Hay photo

Justin Pittaway-Hay

Pharmacokinetics Assessor, MHRA

Justin Pittaway-Hay is a Pharmacokinetics Assessor at the MH...
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Venue

MHRA Offices
1st Floor, 10 South Colonnade
Canary Wharf
London,
E14 4PU

Tel: 020 3080 6000

Travel

DLR
From Canary Wharf DLR station, the site is best accessed via the southern exit onto South Colonnade.  The building is directly opposite to the right.

London Underground
Canary Wharf station has two entrances/exits - east and west - with accessible lifts located at both. The west exit is the most direct entrance/exit for us - follow signs for DLR and at the final set of escalators you should see Paperchase on your right.

Parking

The 10SC building does not offer parking however the Canary Wharf area has four underground public car parks offering 2,500 spaces.  Choose the best one for you here: https://canarywharf.com/getting-here/parking/

Accommodation


Ibis London Docklands Canary Wharf

1 Baffin Way, Off Preston Road, E14 9PE
Tel: +44 207 517 1100
Email: H2177@accor.com
Web: https://www.accorhotels.com/gb/hotel-2177-ibis-london-docklands-canary-wharf/index.shtml


Britannia International Hotel

Marsh Wall, London, E14 9SJ
Tel: +44 871 222 0042
Web: https://www.britanniahotels.com/hotels/the-international-hotel

Register

In order to register for the event, please click the register button below. Please ensure you have all your details ready.

Upon completion an invoice is issued automatically via email to the booker. This includes a secure online credit card payment link and also details of how to make BACS payments etc.

Contact Us

MHRA have appointed Glasgows to organise the event and host the online registration process.

For more information about other MHRA events please visit the conference and education section of the MHRA website: www.mhra.gov.uk.