Search Results for IDMP

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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

ISO IDMP: Another Compliance Project or a new way of Conducting Business? By Rune Bergendorff - Published 19 April 2016

This article discusses Identification of Medicinal Products (IDMP) as a new way of conducting business, the benefits gained by adopting the IDMP model and how IDMP can be implemented to help businesses run more efficiently.

Categories: Features, Europe, EC, EMA, Drugs, Labeling, Packaging

Tags: IDMP, ISO, Identification of Medicinal Products, Regulatory Information Management

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

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

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


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