Search Results for Identification of Medicinal Products

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Identification of Medicinal Products (IDMP) Standards Part 4: Technical Approaches to IDMP By Dieter Schlaps - Published 12 June 2017

This article discusses IT approaches to support a gap analysis and implementation of the upcoming Identification of Medicinal Products (IDMP) standards with regard to generating, collecting and mapping accurate and correct data prior to submission in an effort to prevent delays in a product reaching the market.

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

Tags: Identification of Medicinal Products, IDMP

Identification of Medicinal Products (IDMP) Standards Part 2: The Implementation Roadmap By Dieter Schlaps - Published 28 February 2017

This is part two of a series on the Identification of Medicinal Products (IDMP) standards and their respective implementation guidelines. Part two reports on current IDMP activities and provides the plans and timelines in the IDMP implementation process. Part one presented the reasons for the new standard, the driving forces behind IDMP and the concepts behind the standard.

Categories: Features, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs

Tags: ISO, ISO IDMP, Identification of Medicinal Products

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