PTI is part of the Knowledge & Networking Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.


Mastering Regulatory and Development Strategies for Generics

5 - 6 November 2019

Radisson Blu Edwardian Grafton, London

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. There will be time on this course to discuss the likely implications of Brexit 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

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

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 significant experience in OTC and generic development, as well as global development strategies.

You may also be interested in...