Intellectual Property for Pharma Regulatory Affairs

Understand the impact of IP on pharmaceutical regulatory strategy

Course overview

This practical one-day course will provide an overview of intellectual property (IP) for those working in regulatory affairs.

IP is a fundamental contributing factor to the overall regulatory strategic approach that a company may take and recognition of the different aspects of IP and influences is essential in modern regulatory affairs. Attendance will enable you to understand IP aspects and their impact and influence on regulatory strategy. Key issues covered will include patents, trade marks and copyright as well as data and market exclusivity for global pharmaceutical products. The course will also discuss the EU and FDA regulatory process, highlighting one of the fundamental differences between EU and US systems and the link to patents.

Benefits of attending:

  • Gain an overview of IP and how it contributes to a company’s overall regulatory strategy
  • Understand key IP issues including patents, copyright and freedom to operate (FTO) and how they impact on regulatory affairs
  • Discuss data and market exclusivity for global pharmaceutical products
  • Discuss EU and FDA regulatory processes, their differences and the link to patents

Who should attend?

This seminar will be of interest to development and regulatory managers working in the pharmaceutical industry. It will also be relevant to anyone requiring an overview of the key IP issues relating to regulatory affairs.

Programme

What is IP

  • An overview of:
    • Patents
    • Exclusivity
    • Copyright
    • Trade secrets
What is a patent?
  • Defining the patent
  • Uses of a patent
  • Patents and generic developments
  • Generic legislation for the EU
  • Understanding FTO
Global exclusivity
  • Data exclusivity in the US
  • Data and market exclusivity in the EU
  • Global overview of exclusivity
Influence of IP on regulatory strategy
  • US paragraph
  • Patent declaration
  • Overlap of patents and exclusivity

Product naming and trademarks

Copyright
  • The influence and impact on regulatory affairs

Workshop session: FDA regulatory process and link to patents

Special cases
  • Paediatric legislation
  • Orphan drugs

Use of patents in development strategy

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

Previous customers include...

  • A.A. Thornton & Co
  • CinnaGen