Search Results for data protection

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European Regulatory Roundup: EMA’s PRAC Seeks to Suspend Four Imaging Agents (16 March 2017) By Nick Paul Taylor - Published 16 March 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Clinical, Drugs, Government affairs

Tags: PRAC, imaging agents, data protection, neutropenic enterocolitis

EU Personal Data Protection Reforms Move Forward By Michael Mezher - Published 18 June 2015

After three years of deliberation, the European Council has agreed on its approach to data protection reform, allowing the council to initiate a trilogue with the European Parliament and Commission.

Categories: News, Europe, EC, EMA, Clinical, Government affairs, Research and development

Tags: Personal data, data protection reform, EFPIA

Biologics Exclusivity Still Central in Trade Talk Debate By Michael Mezher - Published 05 June 2015

The length of data exclusivity for biologics remains one of the most controversial aspects of the Trans-Pacific Partnership (TPP), which is poised to be the largest free-trade deal in history.

Categories: News, Asia, Canada, Latin America and Caribbean, Oceania, US, Biologics and biotechnology, Government affairs, Regulatory strategy

Tags: Trans-Pacific Partnership, TPP, biologics exclusivity, regulatory data protection, PhRMA, intellectual property, IP, patents

Trade Talks Stumble Over Biologics Data Exclusivity By Michael Mezher - Published 11 February 2015

Trade officials from around the world are potentially just months away from completing what would be the largest free-trade deal in history, but the completion of that deal is reportedly struggling to get past an issue related to the regulation of biologics.

Categories: Japan, Canada, Latin America and Caribbean, Oceania, US, Biologics and biotechnology, Government affairs, Regulatory strategy

Tags: Trans-Pacific Partnership, TPP, intellectual property, patents, regulatory data protection, data exclusivity, USTR, Michael Froman