Search Results for PRAC

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European Regulatory Roundup: ENVI Urges EC to Exclude Healthcare From Regulation of Professions (15 June 2017) By Nick Paul Taylor - Published 15 June 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, Drugs, Medical Devices

Tags: European Regulatory Roundup, ENVI, antibiotics, PRAC

EMA’s PRAC to Hold First Public Hearing on Use of Valproate Medicines By Zachary Brennan - Published 09 June 2017

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will hold its first public hearing on 26 September 2017 to discuss the safety of using valproate-containing medicines in the treatment of various conditions for women and girls who are pregnant or of childbearing age. 

Categories: News, Europe, EMA, Drugs

Tags: valproate, pregnant women, PRAC

European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017) By Nick Paul Taylor - Published 11 May 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, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European regulatory roundup, PRAC, GMP inspections, flu vaccine guidance

EMA Completes Postmarket Safety Review of Uptravi By Michael Mezher - Published 07 April 2017

Less than two months after launching a safety review of Actelion Pharmaceuticals' pulmonary arterial hypertension (PAH) drug, Uptravi (salexipag), the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) says it did not find an increased risk of death associated with the drug.

Categories: News, Europe, EMA, Prescription drugs, Postmarket surveillance

Tags: Uptravi, salexipag, PRAC

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

EMA Reviews Safety of PAH Medicine Following 5 Deaths in France By Zachary Brennan - Published 14 February 2017

The European Medicines Agency (EMA) signaled Tuesday that doctors can continue to use Actelion Pharmaceuticals’ pulmonary arterial hypertension (PAH) medicine Uptravi (selexipag) while the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) evaluates its safety following the deaths of five patients taking the medicine in France.

Categories: News, Europe, EMA, Crisis management, Drugs, Government affairs

Tags: Uptravi, PRAC, Actelion

European Regulatory Roundup: EMA Offers Draft Proposal on Dissolution of Generics (19 May 2016) By Nick Paul Taylor - Published 19 May 2016

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

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

Tags: European Regulatory Roundup, Bayer, PRAC

European Regulatory Roundup: Germany Joins EU Medical Countermeasure Procurement Alliance (21 April 2016) By Nick Paul Taylor - Published 21 April 2016

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

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Due Diligence, Government affairs

Tags: European Regulatory Roundup, PRAC, medical countermeasures, Gilead, Sovaldi, Harvoni

European Regulatory Roundup: EMA Looks to Cut PML Risk in Patients Taking MS Drug Tysabri (18 February 2016) By Nick Paul Taylor - Published 18 February 2016

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, Medical Devices

Tags: EMA, PRAC, SmPC, Tysabri, MHRA, ingestible sensor

European Regulatory Roundup: EMA Revises Conflict of Interest Rules for Board Members (21 January 2016) By Nick Paul Taylor - Published 21 January 2016

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

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Drugs, Postmarket surveillance

Tags: EMA, EMA Management Board, PRAC, raman spectroscopy, MHRA, pharmacovigilance

EMA Committee Finds No Link Between HPV Vaccines and Rare Conditions By Michael Mezher - Published 05 November 2015

After reviewing the safety profile of human papillomavirus (HPV) vaccines, a European Medicines Agency's (EMA) committee found no evidence the vaccines cause two rare conditions in young women, concluding that "there is no reason to change the way the vaccines are used."

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Postmarket surveillance

Tags: Pharmacovigilance Risk Assessment Committee, PRAC, HPV vaccine, Gardasil, Cervarix, POTS, CRPS

European Regulatory Roundup: CHMP Updates Breast Cancer Guidelines (15 October 2015) By Nick Paul Taylor - Published 15 October 2015

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

Categories: News, Europe, EC, EMA, Drugs, Orphan products, Quality, Regulatory intelligence, Regulatory strategy

Tags: EMA, CHMP, quality control, breast cancer, orphan drug, CVMP, PRAC

EMA Hopes to Boost Drug Safety in Scientific Advice Pilot By Michael Mezher - Published 29 July 2015

In an effort to boost the safety of approved drugs, the European Medicines Agency (EMA) is piloting a new procedure that would allow companies to seek the agency's advice on designing post-authorization safety studies (PASS).

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory strategy

Tags: Post-authorization safety studies, PASS, SAWP, PRAC

EU Committee Confirms Increased Risk with Ibuprofen at High Doses By Michael Mezher - Published 13 April 2015

A European committee has confirmed that high doses of ibuprofen, a popular over-the-counter (OTC) anti-inflammatory drug, can increase a patient's risk for cardiovascular issues.

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Over the counter drugs, Prescription drugs, Postmarket surveillance

Tags: Ibuprofen, NSAIDs, PRAC, Pharmacovigilance Risk Assessment Committee

EU Committee Wants Additional Restrictions on Codeine Use in Children By Michael Mezher - Published 16 March 2015

A European committee is recommending a series of restrictions on the use of medicines containing codeine in children.

Categories: News, Europe, EMA, Active pharmaceutical ingredients, Drugs, Labeling, Postmarket surveillance

Tags: Codeine, Pediatric use, CMDh, PRAC

EMA Initiates Review of Low-T Medications By Alexander Gaffney, RAC - Published 11 April 2014

Categories: EMA

Tags: Hypogonadism, Testosterone, Low-T, PRAC, Latest News, safety, review, EU

Centralized Procedure to see Simplified Submission Process, Says EMA By Alexander Gaffney, RF News Editor - Published 18 March 2013

Categories: EMA

Tags: PRAC, Centralized Procedure, CAT, Centralised Procedure, application, Latest News, CHMP, submission, EU

EMA Announces Huge Overhaul of Operations, Processes By Alexander Gaffney, RF News Editor - Published 19 December 2012

Categories: Meetings, EMA

Tags: PRAC, Scientific Committees, CVMP, Reorganization, CHMP

EMA Appoints Leaders of Newly-Formed Pharmacovigilance Committee By Alexander Gaffney - Published 07 September 2012

Categories: EMA

Tags: Spooner, Raine, PRAC, PhVWP, Latest News, committee, pharmacovigilance