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 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.
What is IP
Product naming and trademarksCopyright
Workshop session: FDA regulatory process and link to patentsSpecial cases
Use of patents in development strategy
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.