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

Regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.

Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.

Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses available in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.

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

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