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:
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
