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                                                                     CPD Accredited

Mastering Regulatory and Development Strategies for Generics

Course Objectives

The majority of all pharmaceutical company revenues now face generic competition. This represents an unprecedented growth in the generics market. With more and more patents expiring since 2006, this global expansion looks set to continue.

Bringing a generic drug to market can be fraught with regulatory challenges and compliance issues. This course will allow the participants to gain a strategic insight into key requirements for developing generics from a global perspective and an overview of the generics market; current trends and practices; and future strategies for regulatory compliance.

Event Highlights

  • Create effective regulatory affairs strategies for post-patent expiry
  • Understand EU and US generic requirements
  • Maximise generic market-share potential
  • Devise best strategy for approval in the EU and US

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(updated 16 December 2014)

Media Partners

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scrip, business intelligence, pti, pti global, pti europe, european regulatory affairs, regulatory affairs

 

scrip, business intelligence, pti, pti global, pti europe, european regulatory affairs, regulatory affairs

Datamonitor, datamonitor healthcare, healthcare, business intelligence, pti, pti global, pti europe, european regulatory affairs, regulatory affairs

Who Should Attend?

This course has been specifically designed to address the needs of:

  • Regulatory Affairs Managers/Officers/ Assistants
  • Compliance Managers
  • Product RegistrationPersonnel
  • Project Managers in Regulatory Affairs
  • Documentation Managers
  • Key contributors to submission procedures

Dates and Venues

09 Oct 2014 - 10 Oct 2014

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