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Filtering on: "organizations agencies/organizations iso"

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Identification of Medicinal Products (IDMP) Standards Part 3: Steps to Prepare for IDMP Implementation By Dieter Schlaps - Published 26 April 2017

This article discusses the gap analysis and preliminary activities necessary to prepare a pharmaceutical company for the upcoming IDMP standards; it is the final article in a three part series on the standards and their respective implementation guidelines. The first two articles presented reasons for the new standard, the driving forces behind IDMP, and the concepts behind the standard as well as the current timelines for introducing IDMP in worldwide markets.

Categories: Features, EMA, FDA, ISO, Drugs

Global Regulatory Developments in Cell and Gene Therapy, Drug Manufacturing Inspections, Regulatory Intelligence Tools and a Preview of March By Gloria Hall - Published 08 March 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in March.

Categories: Features, CFDA, EMA, FDA, Health Canada, ISO, Biologics and biotechnology, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Focus, Feature Articles, Feature Summary

Identification of Medicinal Products (IDMP) Standards Part 1: Impact on the Regulatory World By Dieter Schlaps - Published 21 December 2016

This is part one of a four-part series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. This segment reviews the steps needed to prepare for their global implementation and offers technical solution options for the industry.

Categories: News, Europe, US, EMA, FDA, ISO, Biologics and biotechnology, Drugs

Tags: ISO IDMP, IDMP, Identification of Medicinal Products

How Will ISO 13485:2016 Impact Your Relationship With Suppliers? By Walt Murray - Published 22 November 2016

This article covers how the new ISO 13485 standard affects risk management for suppliers.

Categories: Features, ISO, Manufacturing, Medical Devices

Tags: ISO 13485:2016, Quality Management System

ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning By Michael Mezher - Published 23 September 2016

Speaking at RAPS' 2016 Regulatory Convergence, leading medical device quality systems expert and former FDA official, Kim Trautman, urged attendees to begin their transition to the recently released ISO 13485:2016 as soon as possible.

Categories: News, FDA, ISO, Medical Devices

Tags: ISO 13485:2016

European Commission Publishes New Harmonized Standards for Devices, Implants, IVDs By Zachary Brennan - Published 13 May 2016

In the Official Journal of the European Union, the European Commission on Friday published a new list of the harmonized standards that manufacturers of medical devices, implantable devices and in vitro diagnostic devices can use to demonstrate their products comply with EU law.

Categories: News, Europe, EC, ISO, In vitro diagnostics, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: medical device manufacturing standards, device manufacturing, ISO standards

Seven Pharmaceutical Regulators and NIH Collaborate to Build Drug Ingredient Database By Zachary Brennan - Published 20 April 2016

Drug regulators from the US, Europe, Canada, France, Netherlands, Germany and Switzerland are attempting to build a database of substances used in medicinal products to ease the exchange of such information.

Categories: News, Canada, Europe, US, EMA, FDA, Health Canada, ISO, WHO, Active pharmaceutical ingredients, Compliance, Crisis management, Postmarket surveillance, Quality

Tags: API database, ANSM, Swissmedic, ICH, NCATS

New ISO 13485: Device Companies Have Three Years to Transition By Michael Mezher - Published 01 March 2016

The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003.

Categories: News, Japan, Canada, Europe, Oceania, US, ISO, Medical Devices, Quality

Tags: ISO 13485, ISO 13485:2003, ISO 13485:2016, Quality Management Systems, QMS

European Regulatory Roundup: EMA Updates HRT Warning on Ovarian Cancer Risk (14 January 2015) By Nick Paul Taylor - Published 14 January 2016

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

Categories: News, Europe, EMA, ISO, MHRA, Clinical, Drugs, Medical Devices

Tags: HRT, ovarian cancer, ISO, ANSM, Danish Medicines Agency

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

ISO IDMP - Putting the Pieces Together for Investigational Data By Dorte Frejwald Christiansen - Published 10 August 2015

This  article reviews the European Medicines Agency (EMA) Master Data Management Roadmap (MDM), the role of the European Union Drug Regulating Authorities Clinical Trials database (EudraCT) and the European Union (EU) portal in regard to investigational  product information.

Categories: Articles, Features, Europe, EMA, ISO, Research and development

Tags: investigational data, clinical trials, pharmaceuticals, ISO, International Organization for Standardization, IDMP, Identification of Medicinal Products

IMDRF Proposes QMS Principles for Software as a Medical Device By Michael Mezher - Published 08 April 2015

In recent years, general-purpose devices such as personal computers, smartphones and wearables have enabled the proliferation of “software as a medical device” (SaMD) products.

Categories: News, GHTF, IMDRF, ISO, Manufacturing, Medical Devices, Project management, Quality

Tags: Software as a Medical Device, SaMD, ISO 13845:2003, QMS

Going Digital: EMA to Ditch Paper, Require Electronic Application Forms By Michael Mezher - Published 26 February 2015

In an effort to reduce its administrative burden, the European Medicines Agency (EMA) will soon require companies to use electronic forms for a number of application types. The move is part of a wider effort in the EU to transition to international and electronic standards.

Categories: News, Europe, EC, EMA, ISO, Drugs, Regulatory strategy, Submission and registration

Tags: eCTD, CTD, electronic application forms, eAFs, eSubmissions Roadmap, ISO IDMP

With Eye on Improving Quality, Indian Regulator gets First ISO Certification By Michael Mezher - Published 24 February 2015

India’s regulatory authority has announced that one of its offices has become the first in the country to become certified by the International Organization for Standardization (ISO).

Categories: News, India, CDSCO, ISO, Government affairs

Tags: ISO, International Organization for Standardization, ISO 9001:2008, ISO 9001, Quality Management Systems, QMS

EU Task Force to Implement New Drug Identification Standards By Michael Mezher - Published 23 February 2015

The European Medicines Agency (EMA) has announced it is putting together a task force to oversee the implementation of new standards for identifying drugs.

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

Tags: ISO, IDMP, XEVMPD

EMA Explains Centralized Product Database, Talks Future Changes By Michael Mezher - Published 18 February 2015

The European Medicines Agency (EMA) released a new document intended to clarify data submission requirements for medicines authorized in the European Economic Area (EEA).

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

Tags: Pharmacovigilance, EudraVigilance, XEVMPD, ISO IDMP

Public Comment Period Opens on ISO 9001, Major Device Quality Standard By Alexander Gaffney, RAC - Published 21 July 2014

The International Standards Organization (ISO), an international group whose standards are widely used in the life sciences industry, has finally released a draft of its latest iteration of the ISO 9001 standard for public consultation.

Categories: News, ISO, In vitro diagnostics, Manufacturing, Medical Devices, Quality

Tags: ISO 9001, QMS, Quality Management System, Consultation, International Standards Organization, ISO

Medical Device Group: Syringe Compatibility Guidance Raises 'Important Concerns' By Alexander Gaffney, RF News Editor - Published 05 August 2013

Categories: US, FDA, ISO

Tags: draft guidance

ISO Starts Revision Process for Quality Management Systems Guidance By Alexander Gaffney, RF News Editor - Published 01 July 2013

Categories: ISO

Tags: medical device

ISO Membership to Foster China's Tissue Engineered Device Industry By Louise Zornoza, RegLink - Published 08 April 2013

Categories: CFDA, ISO

Dozens of Medical Device Standards Adopted, Re-Affirmed by FDA By Alexander Gaffney, RF News Editor - Published 15 January 2013

Categories: FDA, ISO

Tags: CLSI, ANSI, ASTM, IEC, Latest News, Standards, medical device

New Standard Aimed at Strengthening Child-Proofing Systems By Alexander Gaffney, RF News Editor - Published 20 December 2012

Categories: ISO, Packaging

ISO Releases New Voluntary Anti-Counterfeiting Standard By Alexander Gaffney - Published 05 September 2012

Categories: ISO

Tags: ISO 12931, Anti-Counterfeiting, Counterfeiting, Standard, Latest News

FDA Approves 32 New Medical Device Standards By Alexander Gaffney - Published 20 August 2012

Categories: FDA, ISO

Tags: CLSI, ANSI, ASTM, IEC, Latest News, Standards, medical device

New ISO Standard Released for Characterizing Nanoparticles By Alexander Gaffney - Published 03 July 2012

Categories: ISO

Tags: Nano, International Standards Organization, Standard, nanomaterials, nanotechnology, Latest News, guidance