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