Search Results for Guido Rasi

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European Regulatory Roundup: Swissmedic Pilots Changes to Accelerate Drug Authorizations (5 October 2017) By Nick Paul Taylor - Published 05 October 2017

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs

Tags: accelerated approval, Swissmedic, CQC, Guido Rasi

European Regulatory Roundup: Lead Brexiteer Muddies Waters on UK-EMA Relationship (2 February 2017) By Nick Paul Taylor - Published 02 February 2017

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

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Brexit, Jeremy Hunt, David Davis, Guido Rasi

EMA's Rasi on Brexit: Climate of Uncertainty Straining Worker Motivation By Zachary Brennan - Published 08 November 2016

At a meeting of the European Parliament’s Committee on the Environment, Public Health and Food Safety on Tuesday, the European Medicines Agency’s Executive Director Guido Rasi said the agency needs additional measures to support its staff as the uncertainty over Brexit is taking its toll on staffers.

Categories: News, Europe, EC, EMA, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: European Parliament, Guido Rasi, Brexit

EMA's 2015 Annual Report: Interest in Scientific Advice Increasing By Michael Mezher - Published 17 May 2016

The European Medicines Agency (EMA) on Tuesday released its Annual Report 2015 touting its performance and key achievements for the year.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: Guido Rasi, Sir Kent Woods, New active substances, Scientific Advice

EMA Looks to Accelerate New Therapies Targeting Unmet Needs By Michael Mezher - Published 07 March 2016

The European Medicines Agency (EMA) on Monday launched its new PRIME (PRIority MEdicines) scheme which aims to streamline the development of promising new therapies that meet unmet medical needs.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Regulatory strategy, Submission and registration

Tags: PRIME, Priority Medicines, Guido Rasi, Rapporteur, Scientific advice

EMA Executive Director: Agency Ready for Challenges Ahead By Michael Mezher - Published 09 December 2015

The newly reinstated head of the European Medicines Agency (EMA), Professor Guido Rasi, on Wednesday outlined his priorities for his new five-year term.

Categories: News, Europe, EMA, Communication, Government affairs

Tags: Guido Rasi, PRIME, Adaptive Pathways, Transparency

Rasi Returns to Head EMA for Five-Year Term By Michael Mezher - Published 16 November 2015

The European Medicines Agency's (EMA) former leader has officially returned to head the agency today, after being forced to step down from his previous appointment last November.

Categories: News, Europe, EC, EMA, Government affairs

Tags: Guido Rasi

A Second Chance? EMA Board Nominates Guido Rasi to Lead Again By Zachary Brennan - Published 01 October 2015

The European Medicines Agency’s (EMA’s) Management Board on Thursday nominated Professor Guido Rasi as the executive director of the agency, a little less than a year after he was forced to step down from the position.

Categories: News, Europe, EMA, Business and Leadership, Quality, Regulatory intelligence, Regulatory strategy

Tags: Guido Rasi, Sir Kent Woods, EMA, EMA Executive Director

EMA Appeals Decision That Ousted Former Executive Director By Michael Mezher - Published 18 June 2015

The European Medicines Agency (EMA) is pressing forward with its plans to appeal a decision that annulled the appointment of its former executive director, Guido Rasi, Politico reports.

Categories: News, Europe, EC, EMA, Government affairs

Tags: Guido Rasi, Civil Service Tribunal

EMA Scrambles to Consider Options After Leader Ousted By Alexander Gaffney, RAC - Published 02 December 2014

Members of the European Medicines Agency (EMA) met last week to consider an unprecedented question: How should they select a new, permanent leader after they were forced to fire the last one?

Categories: News, US, EC, EMA

Tags: Guido Rasi, Kent Woods, EMA Management Board

EMA's Top Drug Regulator, Guido Rasi, Forced to Step Down By Alexander Gaffney, RAC - Published 14 November 2014

In a major development, the head of the European Medicines Agency (EMA), Guido Rasi, has been forced to step down by the EU Civil Service Tribunal after adjudicators found that the European Commission had improperly selected him in 2011.

Categories: News, Europe, EC, EMA

Tags: Guido Rasi, European Commission, EMA, EMA Executive Director

EMA Defends Changes to Trials Transparency Plan as Advocates go on Attack By Alexander Gaffney, RAC - Published 11 June 2014

The European Medicines Agency (EMA) is defending its updated clinical trials transparency policy, now derided by some as ineffectual and contrary to its original aims, as being a "compromise approach" meant to placate concerns within industry that too much transparency would have had detrimental effects.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Ethics

Tags: Clinical Trials Transparency, Guido Rasi, CSR, Clinical Data Transparency

EMA: Opportunity Costs of Risk-Averse Approaches Must be Taken into Account by Regulators By Alexander Gaffney, RF News Editor - Published 18 November 2013

Categories: EMA

Tags: Guido Rasi, EU

EMA Management Board Turns Focus to Regulatory Science and Faster Approvals By Alexander Gaffney, RF News Editor - Published 26 March 2013

Categories: EMA

Tags: Management Board, Guido Rasi, Latest News, regulatory science, EU

EC Looking to Recommend Tougher Regulations on Medical Devices, More Member State Coordination By Alexander Gaffney - Published 17 January 2012

Categories: EC, EMA, Medical Devices

Tags: Guido Rasi, Andrew Lansley, PIP, Latest News, Class III, EU

Lansley Seeks Additional Data Collection, Looks to Improve UK & EMA Regulations By Alexander Gaffney - Published 12 January 2012

Categories: EMA, Medical Devices

Tags: Guido Rasi, Scandal, Andrew Lansley, Breast Implant, PIP, Latest News, UK, NHS, regulation

EU to Unveil New Follow-on Biologic Guidelines in Late Q1 By Alexander Gaffney - Published 06 January 2012

Categories: EMA

Tags: Guido Rasi, Latest News, Biogenerics, Generics, Biosimilars, Follow-on Biologics, EU