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Mastering Regulatory and Development Strategies for Generics

19 - 20 November 2020

Radisson Blu Edwardian Grafton, London

Generic manufacturers are faced with financial and commercial pressures when producing an off-patent drug as they face the prospect of many competitors bringing the same drug to market. This puts greater emphasis on pricing strategy, with prices driven down to remain competitive and resulting in lower margins. It is therefore important for generic manufacturers to competently manage the regulatory approval and compliance process to keep costs down.  
 
This 2-day course will provide you with 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. You will examine the process in the EU and US comparing and contrasting with examples and case studies. As well as learning about small molecules you will examine the regulatory procedures for biosimilars, the biological generic equivalent, which are growing year on year.  
 
There will be time on this course to discuss the likely implications of Brexit on regulatory 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

2 weeks before the course starts, delegates will be enrolled on to the online element of Introduction to Mastering Regulatory & Developmental Strategies for Generics course. Through this they will have access to:

  • Bitesize introductory videos
  • Pre-reading materials
  • Trainer information
  • Discussion forum to interact with peers and the trainer

Delegates will continue to have access to the online element after the course has ended for networking and development purposes.

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

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