Overview

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.

Who should attend?

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

Learning objectives

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

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

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TUT03: Interactions between Regulatory and Intellectual Property, Product Liability, and Data Privacy

Overview

Who should attend?

Learning objectives

Be informed and stay engaged.