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maandag 6 november 2017

Applying for a Marketing Authorisation in the UK?

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Applying for a Marketing Authorisation in the UK?

Advice from the Regulator on getting 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.

This event is aimed at Pharmaceutical scientists and Regulatory Affairs staff responsible for managing or preparing Marketing Authorisation applications. The course will benefit both experienced as well as new staff involved with MA applications.


Two new presentations have been added to the agenda:

  • Product Naming and Livery with a focus on OTC products
  • Validation of abridged applications – hints and tips

 Why attend?

  • Hear from MHRA on how to minimise deficiencies in new Marketing Authorisation Applications
  • Bioequivalence/biowaivers – the regulatory fundamentals
  • Therapeutic Equivalence – what you need to know
  • Learn from case studies how to avoid frequently observed quality issues
  • Brexit update

 Benefits of attending?

  • Save time by minimising deficiencies when completing your dossier
  • Meet MHRA experts and have the opportunity to ask questions

 

    Dates

    Wednesday 29 November – Thursday 30 November 2017

    Venue

    etc.venues Victoria
    1 Drummond Gate
    Pimlico
    London
    SW1V 2QQ

    Time

    09:30 -16:00

    Programme

    Fees

    Standard Non-Commercial: £525 + VAT
    Standard Industry: £875 + VAT

    CPD logo

    Delegates attending the Applying for a Marketing Authorisation in the UK? Event will be eligible to claim CPD points.

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