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Mastering Regulatory and Development Strategies for Generics

8 - 9 April 2019


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.

Taking place alongside eRegulatory Summit and Global Regulatory Affairs Summit 2019, as a delegate on this course you will also receive access to the conference exhibit areas and evening receptions offering you the opportunity to network with your peers in the industry.

  • 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

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

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.

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