Tutorial 11: Interactions between Regulatory and Intellectual Property, Privacy and Product Liability

Interactions between, on the one hand, the regulatory regime and, on the other hand, intellectual property (example: Paediatric Regulation), privacy (example: clinical trials or pharmacovigilance), and product liability i.e.content of Summary of Product Characteristics (SmPC), are increasing. As a result, those matters can no longer be approached in isolation, and a more comprehensive perspective is required when addressing regulatory issues. The tutorial aims at explaining the basic rules of intellectual property, privacy and product liability and to link them with regulatory aspects to highlight the interactions between the rules and therefore the impact that regulatory issues may have on intellectual property, privacy and product liability. This should allow the participants to have a broader perspective when approaching regulatory issues and to identify the possible ramifications of solutions.  One hour will be dedicated to each set of rules (intellectual property; privacy; and product liability).

Members of regulatory affairs or product development team of companies and in house lawyers who want to learn the basics of intellectual property, privacy, and product liability rules as applied to the pharmaceutical sector.

 

At the conclusion of this tutorial, attendees will be able to:

• Explain and discuss the basics of intellectual property, privacy, and product liability rules applicable to medicinal products
• Identify and better address the regulatory issues that present an intellectual property, privacy, privacy or product liability aspect