About

We are pleased to announce a two day event ‘Applying for a Marketing Authorisation in the UK’ focused on the content of an MA submission, how experts identify an ‘ideal’ data package and how this can reduce deficiencies during assessment, and help ‘Get it right first time’.

This CPD-accredited event will provide helpful advice for all regulatory affairs staff preparing marketing authorisation applications.  Gain a clear understanding of how to minimise deficiencies when preparing new MA applications as well as the regulatory fundamentals of drug/device combinations, regulatory fundamentals of bioequivalence and learn which points to consider when submitting a WEU application.

Agenda

  • Registration and Refreshments

  • Welcome and Chairman's introduction

    MHRA as centre for Regulatory excellence and Brexit update (including UK as RMS DCP, leading National regulator)

  • Regulatory Framework - for abridged applications

  • Validation, responses and end of procedure - hints and tips

  • Refreshment Break

  • Minimising Deficiencies in the Quality Dossier - Part I

  • Lunch and networking

  • Minimising Deficiencies in the Quality Dossier - Part II

  • Panel questions Minimising Deficiencies Part I & II

  • Drug/Device Combinations and Products Supplied with a medical device

    Regulatory requirements

  • Refreshments

  • Panel questions

    Sli:do

  • Closing remarks

  • Registration and Refreshments

  • Welcome

  • OTC Medicines: Product Naming and Livery

  • Bioequivalence - what you need to know

    Pharmaceutical perspectives and biowaivers

  • Refreshment Break

  • Bioequivalence - what you need to know

    Study design/criteria and PK/BE

  • Bioequivalence - what you need to know

    Frequent issues and how to avoid them

  • Lunch and Networking

  • Therapeutic Equivalence - what you need to know

    - Regulatory framework and CHMP guidelines
    - Common pitfalls/deficiencies and how to avoid them
    - Waivers for locally applied/acting products
    - Therapeutic Equivalence Studies

  • Well-established Use

    - Points to consider when submitting a WEU application
    - Regulatory aspects
    - Submitting a high quality bibliographic application

  • Refreshments

  • Panel questions

    Sli:do

  • Closing remarks

Meet The Speakers

Siu Ping Lam photo

Dr Siu Ping Lam

Director of Licensing Division

Dr Siu Ping Lam is Director of Licensing Division at the Med...
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Elizabeth Baker photo

Elizabeth Baker

Group Manager, Licensing Division

Elizabeth Baker (Liz) is a pharmacist with an MSc in Biophar...
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Linda Anderson photo

Dr Linda Anderson

Expert Pharmaceutical Assessor

Dr Anderson joined MHRA in 1987. Within MHRA, she is an Expe...
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Melanie Pires photo

Dr Melanie Pires

Senior Pharmaceutical Assessor

Melanie Pires is a Senior Pharmaceutical Assessor in the Lic...
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Lesley Anderson photo

Dr Lesley Anderson

Senior Pharmaceutical Assessor

Dr Anderson (BSc PhD FFRPS MRPharmS MTOPRA) is a Senior Phar...
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Emmanouil Zouridakis photo

Dr Emmanouil Zouridakis

Senior Medical Assessor

Dr Emmanouil Zouridakis is Senior Medical Assessor at the Me...
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Julia Saperia photo

Julia Saperia

Statistical Assessor

Julia Saperia is a Statistical Assessor in the Licensing div...
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Joseph Lim photo

Dr Joseph Lim

Senior Pharmaceutical Assessor

Dr Lim is a Senior Pharmaceutical Assessor in the Licensing...
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Barbara Spruce photo

Dr Barbara Spruce

Clinical Assessor

Barbara works in the Licensing Division, principally  o...
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Elspeth Gray photo

Dr Elspeth Gray

Senior Pharmaceutical Assessor and Deputy PLAT Manager

Elspeth is a senior pharmaceutical assessor and Deputy Unit...
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Abigail Moran photo

Dr Abigail Moran

Senior Pharmaceutical Assessor

Abi is a senior pharmaceutical assessor in the Licensing Div...
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Essam Kerwash photo

Dr Essam Kerwash

Pharmacokinetics Assessor

Dr Essam Kerwash is a pharmacokinetics assessor at the MHRA...
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Elena Razzano photo

Elena Razzano

Senior Pharmaceutical Assessor, Licensing Division

Ms Elena Razzano is a Senior Pharmaceutical Assessor in the...
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Julia Coombes photo

Dr Julia Coombes

Scientific Assessor, Patient Information Quality Unit

Dr Julia Coombes completed her BSc in Physiology and PhD at...
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Zoran Simic photo

Dr Zoran Simic

Senior Medical Assessor

Dr Zoran C. Simic is a senior medical assessor at MHRA and t...
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Venue, Travel & Directions

etc. venues Victoria

1 Drummond Gate

Victoria

SW1V 2QQ

https://www.etcvenues.co.uk/venues/victoria

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