Intellectual Property for Pharma Regulatory Affairs (London, United Kingdom - November 5, 2018) - ResearchAndMarkets.com

September 20, 2018

DUBLIN--(BUSINESS WIRE)--Sep 20, 2018--The “Intellectual Property for Pharma Regulatory Affairs” conference has been added to ResearchAndMarkets.com’s offering.

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.

Benefits in attending:

Gain an overview of IP and how it contributes to a company’s overall regulatory strategy Understand key IP issues including patents, copyright and freedom to operate and how they impact on regulatory affairs Discuss data and market exclusivity for global pharmaceutical products Discuss EU & FDA regulatory processes, their differences and the link to patents

Who Should Attend:

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)

An overview of: PatentsExclusivityCopyrightTrade secrets

What is a patent

Designing the patent Uses of a patent Patents and generic developments Generic legislation for the EU Understanding freedom to operate

Global exclusivity

Data exclusivity in the US Data and market exclusivity in the EU Global overview of exclusivity

Influence of IP on regulatory strategy

US paragraph Patent declaration Overlap of patents and exclusivity

Product naming and trademarks


The influence and impact on regulatory affairs

Practical exercise on FDA regulatory process and link to patents

Special cases

Paediatric legislation Orphan drugs

Use of patents in development strategy

For more information about this conference visit https://www.researchandmarkets.com/research/b6lbf8/intellectual?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20180920005327/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Manager


For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Related Topics:Pharmaceuticals,Intellectual Property



SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 09/20/2018 05:53 AM/DISC: 09/20/2018 05:53 AM


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