Abridged Applications

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COURSE OVERVIEW

ABRIDGED APPLICATIONS – The Regulator and the Industry View

This seminar is concerned with the current aspects of abridged applications and will include information on any new issues arising in relation to these applications.

Safety, quality and efficacy will be addressed in an integrated fashion and the importance of application registration planning will be stressed.

A basic knowledge of the application procedure will be assumed

WHY YOU SHOULD ATTEND

TOPICS TO BE COVERED

  • The legislation associated with Abridged Applications
  • Paediatrics and Abridged Applications
  • Bioequivalence, BCS Classifications and Biowaiver
  • Clinical Issues and SmPC
  • Pharmaceutical and Quality Issues
  • Drug substance data, European drug master files and CEPs

WHO SHOULD ATTEND

  • Managing Directors
  • Research and Development Directors
  • Medical Directors
  • Clinical Research Managers and Clinical Pharmacologists
  • Research and Development and Registration Managers
  • Quality Assurance Managers
  • New recruits to registration
  • Regulatory and CMC Managers
  • New Recruits to Registration

Building:The Rembrandt Hotel
Address:11 Thurloe Place
CountryUnited Kingdom
Type:Seminar
Websitehttps://management-forum.co.uk/product/details/1695?referrer=lwsept16
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