Search Results for Pharmacovigilance

Showing 1 – 25  of 78

European Regulatory Roundup: EMA Revises Pharmacovigilance Guideline After Danish Agency Spots 'Big Problem' (10 August 2017) By Nick Paul Taylor - Published 10 August 2017

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

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

Tags: pharmacovigilance, DKMA, Swissmedic

EMA Reports Rise in Pharmacovigilance Inspections in 2016 By Michael Mezher - Published 08 August 2017

In a report released on Tuesday, the European Medicines Agency (EMA) said the number of pharmacovigilance inspections for centrally authorized products rose in 2016, mainly driven by an increase in routine inspections carried out under national inspection programs.

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

Tags: Pharmacovigilance, Pharmacovigilance Inspections

European Regulatory Roundup: EU Device Regulations Come Into Force; Swissmedic Clarifies Pharmacovigilance Process (1 June 2017) By Nick Paul Taylor - Published 01 June 2017

The European Union medical device and in-vitro diagnostic (IVD) regulations have come into force. The passing of the date marks the start of the phased, multi-year introductions of requirements set out in the two documents.

Categories: Europe, EC, EMA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Postmarket surveillance, Submission and registration

Tags: European Regulatory Roundup, Regulatory Roundup, EU Regulatory Roundup, Brexit, MDR, IVDR, Swissmedic, Pharmacovigilance,

UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers By Zachary Brennan - Published 01 May 2017

No one knows what UK pharmacovigilance will look like after the UK leaves the EU, and that uncertainty puts the many Qualified Persons Responsible for Pharmacovigilance (QPPV) residing in the UK in a precarious position.

Categories: News, Europe, EC, EMA, MHRA, Government affairs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: Brexit, pharmacovigilance, Ian Hudson

Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (21 March 2017) By Nick Paul Taylor - Published 21 March 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, TGA, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance

Tags: Asia regulatory roundup, India drug supply, TGA pharmacovigilance

Four Pharma Companies Lead in Regulatory, Legal Compliance By Zachary Brennan - Published 14 November 2016

Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Bill & Melinda Gates Foundation’s Access to Medicines Index.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, ICH, WHO, Biologics and biotechnology, Drugs

Tags: pharmacovigilance, pharmaceutical regulatory compliance, Gilead, Sanofi, Takeda, Pfizer, Novartis, Takeda, Gates Foundation, pharma regulations

European Regulatory Roundup: When is an App a Medical Device? MHRA Explains (25 August 2016) By Nick Paul Taylor - Published 25 August 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, Compliance, Crisis management, Drugs, Medical Devices

Tags: medical app, pharmacovigilance, Boehringer, AbbVie

EMA Releases List of Medical Events for Pharmacovigilance Monitoring By Michael Mezher - Published 19 August 2016

The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other European regulators to identify suspected adverse events.

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

Tags: Pharmacovigilance, EudraVigilance, Designated Medical Events, Important Medical Events

EMA Adopts New Biologic, Biosimilar Pharmacovigilance Guidance By Michael Mezher - Published 15 August 2016

The European Medicines Agency (EMA) on Monday announced new recommendations for monitoring the safety of biologics and biosimilars. The guidance will take effect on 16 August 2016.

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

Tags: Pharmacovigilance

EU Regulators Tout Progress on Pharmacovigilance Since New Legislation Enacted By Michael Mezher - Published 08 August 2016

The European Commission (EC) and European Medicines Agency (EMA) say their combined efforts have resulted in improved drug safety monitoring since new legislative requirements went into effect in 2012, according to a report released by the EC on Monday.

Categories: News, Europe, EC, EMA, Drugs, Postmarket surveillance

Tags: Pharmacovigilance, GVP

MHRA Drops Pharmacovigilance Compliance Reporting Requirements By Michael Mezher - Published 26 July 2016

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) says it no longer wants drugmakers to submit regular drug safety surveillance compliance reports, unless they are specifically requested by the agency.

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

Tags: Pharmacovigilance, GPvP, GVP

Off-Label Drug Use and Pharmacovigilance: EMA Outlines What MAHs Need to Collect and Report By Zachary Brennan - Published 23 May 2016

Pharmaceutical companies operating in the EU will need to collect and report information on the off-label use of their medicines under new obligations making their way from draft to final form at the European Medicines Agency (EMA) this summer.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance

Tags: off-label drug use, off label, EU pharmacovigilance

European Regulatory Roundup: EMA Sets Up Antimicrobial Monitoring Program (14 April 2016) By Nick Paul Taylor - Published 14 April 2016

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

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Biologics and biotechnology, Compliance, Drugs, Government affairs, Postmarket surveillance

Tags: European Regulatory Roundup, antimicrobials, quality documentation, pharmacovigilance

EMA Begins Pharmacovigilance Training Courses By Zachary Brennan - Published 08 April 2016

The European Medicines Agency (EMA) this week began running a series of pharmacovigilance training sessions to help companies and regulators meet their obligations when using EudraVigilance, a centralized European database of suspected adverse reactions to medicines in the European Economic Area (EEA).

Categories: News, Europe, EC, EMA, MHRA, Drugs, Postmarket surveillance, Product withdrawl and retirement

Tags: EMA, pharmacovigilance, EudraVigilance

European Regulatory Roundup: EMA Proposes Major Changes to Risk Management (3 March 2016) By Nick Paul Taylor - Published 03 March 2016

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

Categories: News, Europe, EC, EMA, MHRA, NICE, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: good pharmacovigilance practices, NICE, Cancer Drugs Fund, Swissmedic

EU MAHs Will See Relief on Some Pharmacovigilance Updates By Zachary Brennan - Published 22 January 2016

Beginning 1 February, drug companies operating in the EU will only have to update a database for some pharmacovigilance changes and will no longer have to submit a particular IA variation to the European Medicines Agency (EMA).

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Manufacturing, Postmarket surveillance

Tags: pharmacovigilance, EMA, EU drug databases

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

European Commission to Evaluate EMA’s Fee System By Zachary Brennan - Published 22 December 2015

Late next year, the European Commission will begin reviewing the pharmaceutical company fee system that helps fund the European Medicines Agency (EMA).

Categories: News, Europe, EC, EMA, Clinical, Compliance, Drugs, Due Diligence, Ethics, Government affairs, Manufacturing, Orphan products, Regulatory strategy, Reimbursement, Submission and registration

Tags: EMA, pharmacovigilance, marketing authorization fees in EU, marketing authorisation

European Regulatory Roundup: EMA Offers New Pharmacovigilance Updates (17 December 2015) By Nick Paul Taylor - Published 17 December 2015

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

Categories: News, Europe, EMA, Crisis management, Drugs, Government affairs, Medical Devices, Quality

Tags: EMA, MHRA, pharmacovigilance, asthma

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

EMA's Medical Literature Monitoring Service Goes Operational By Zachary Brennan - Published 01 September 2015

The European Medicines Agency (EMA) on Tuesday launched its medical literature monitoring service to help identify suspected adverse reactions and reduce the duplication of such efforts by thousands of pharma and biotech companies.

Categories: News, Europe, EMA, Drugs, Postmarket surveillance, Regulatory strategy

Tags: Medical literature, pharmacovigilance, postmarket surveillance

Bringing Structure to Substance Information By Niels Henriksen - Published 28 August 2015

This article discusses compliance challenges  pharmaceutical companies face with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standard for structured  substance information.

Categories: Articles, Features, ISO, Active pharmaceutical ingredients, APIs, Postmarket surveillance

Tags: pharmaceuticals, pharmacovigilance, International Organization for Standardization, ISO, Identification of Medicinal Products, IDMP

Managing Pharmacovigilance in Digital Health Initiatives Published 14 August 2015

This article analyzes adverse event reporting obligations and identifies ways to reduce regulatory risk and cost associated with digital health initiatives.

Categories: Articles, Features, US, FDA, Prescription drugs, Postmarket surveillance

Tags: pharmacovigilance, pharmaceutical, adverse events, adverse event reporting, digital health

MHRA to Pilot Stand-Alone Pharmacovigilance Inspections for Contractors By Michael Mezher - Published 13 August 2015

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is considering conducting "stand-alone" inspections of companies that conduct pharmacovigilance activities on a contractual basis for drugmakers.

Categories: News, Europe, MHRA, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance, Regulatory strategy

Tags: Pharmacovigilance, inspections

EMA Updates Two Pharmacovigilance Guidelines By Michael Mezher - Published 11 August 2015

Today, the European Medicines Agency (EMA) released two revised guidelines, one final and one draft, to clarify certain aspects of pharmacovigilance in the EU.

Categories: News, Europe, EMA, Drugs, Postmarket surveillance, Regulatory strategy

Tags: Pharmacovigilance, Post-authorisation safety studies, PASS, audits