概要
Interactions between the regulatory regime, and intellectual property regulatory issues (supplementary protection certificate, paediatric regulation, and regulatory exclusivities), privacy (clinical trials or pharmacovigilance), product liability (content of the SmPC) and competition (delay of generic entry) on the other, 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 to explain the basic rules of intellectual property, product liability and privacy and to link them with regulatory aspects in order to highlight the interactions between the rules and therefore the impact that regulatory issues may have on intellectual property, product liability and privacy. 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, product liability and privacy), and the presentation of each set will emphasise the regulatory implications of the rules.