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dinsdag 17 oktober 2017

Applying for a Marketing Authorisation in the UK? Advice from the Regulator on getting it right first time


Applying for a Marketing Authorisation in the UK?

Advice from the Regulator on getting it right first time for abridged applications

29-30 November 2017 – etc.venues Victoria, London


Join the twitter conversation at #MarketingAuthorisation

Early-bird tickets closing soon!

Places are filling up fast for our Marketing Authorisation event on 29-30 November 2017. Don't miss out on booking your place at the reduced early-bird rate.

Early bird tickets are available now!

Early-bird rate £795+VAT

Standard rate £875+VAT

A limited number of early-bird rates are available and will be offered on a first come first serve basis.

Book now so you don't miss out

 

Why attend?

  • Hear from MHRA experts on how to minimise deficiencies in new Marketing Authorisation Applications
  • Bioequivalence – pharmaceutical perspectives, biowaivers and study design/criteria, pharmacokinetics and bio-equivalence
  • Therapeutic Equivalence – what you need to know
  • OTC Medicines – Product Naming and Livery
  • Validation – hints and tips
  • Well-established use – submitting a high quality application
  • Brexit update

Benefits of attending:

  • Save time by minimising deficiencies when compiling your dossier
  • Meet MHRA experts and have the opportunity to ask questions
  • Learn from case studies how to avoid frequently observed quality issues

 

 

Register now!

Who should attend?

This event is aimed at Pharmaceutical scientists and Regulatory Affairs staff responsible for preparing Marketing Authorisation applications. 

The course will benefit both experienced as well as new staff involved with the preparation of new MA applications.

Summary of the event:

  • Focus on quality: Minimising deficiencies to reduce timelines
  • Bioequivalence/Biowaivers – the regulatory fundamentals
  • Submitting a WEU application – points to consider

CPD logo

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