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, trademarks 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.
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 Intellectual Property (IP)
What is a patent
Influence of IP on regulatory strategy
Product naming and trademarks
Practical exercise on FDA regulatory process and link to patents
Use of patents in development strategy
Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.
He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He currently has a total of 32 years pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.