Mastering Regulatory and Development Strategies for Generics

• Examine the impact of EU and US regulatory approval for generic products
  
• Clarify the criteria for submitting generic applications in Europe and US
  
• Enable creation of development plan for "Right First Time" generics
  
• Assess the major developments in patents and trademarks for global generics
  
• Maximise generic market-share potential
  
• Formulate regulatory strategies to achieve successful regulatory performance and compliance
  
• Pinpoint key developments in market exclusivity
  

Andrew Willis

Previously Vice President of Regulatory Affairs and Consulting Services at Catalent Pharma Solutions, Andrew is currently an independent regulatory affairs and pharmaceutical development consultant. Andrew has over 28 years of experience in regulatory affairs and pharmaceutical development, with specific experience of EU and US registrations, CMC regulatory requirements and multiple clinical aspects related to successful registration of drug products. Andrew is considered an expert in lifecycle management and has signifi cant experience in OTC and generic development, as well as global development strategies.

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