Showing items tagged as European Medicines Agency (EMA)

  • 2019-bl-thumb-achieve-greater-operational-compliance

    Achieve Greater Operational Compliance and Efficiencies in Pharma Through IDMP Implementation

    The Identification of Medicinal Products (IDMP) is a set of ISO data standards that will help ensure that pharma organizations around the world speak the same language when it comes to product information and definitions. Find out how IDMP can also help improve your company’s internal quality processes.

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    Keeping Up With Regulatory Changes for Medical Devices

    Don’t let the cash flow slow when new regulatory guidance for medical device manufacturers is handed down by the FDA and other agencies in FY2018. Rather, follow these simple steps that will allow you to get your device to market faster to help your company maximize profit and minimize delays.

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  • 2018-bl-thumb-beyond-the-mandates

    Beyond the Mandates: The Business Value of Mass Serialization and Supply Process Visibility, Part 1

    A look at how how global mandates for implementing mass serialization within supply chain management are coming to fruition in U.S. and European markets, just to name a couple, and how the use of technology can help supply chain managers get a better handle on this task through automated, real-time visibility.

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  • 2018-bl-thumb-regulatory-barriers-for-biotech-medtech-startups-europe

    Regulatory Barriers to Innovation for Startups

    France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

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  • 2017-bl-thumb-what-is-doc-control-system

    What Biotech Startups Need to Do to Slay the Competition

    Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

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  • 2018-bl-thumb-link-between-regulation-quality-systems-data-integrity

    The Link Between Regulation, Quality Systems and Data Integrity, Part 2

    An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.

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    The Link Between Regulation, Quality Systems and Data Integrity, Part 1

    The emergence of new guidelines on data integrity, and the interpretation of that data via audits and inspections, doesn't detract from pre-existing elements of regulation, particularly Annex 11 of the European Union’s (EU) good manufacturing practice (GMP) guidelines.

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  • 2018-bl-thumb-top-med-device-trends-asia-pacific

    Top Medical Device Trends in Asia-Pacific and Around the World

    The speed at which the medical device industry is changing and evolving is perhaps unrivaled in the life sciences industry. Medical device manufacturers are experiencing disruption from small companies and startups entering the market1, tech giants like Amazon are investigating and investing in medical device expertise and cybersecurity concerns are on the rise.

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  • 2018-bl-thumb-british-mhra

    UK's MHRA Issues Final Guidance on GxP Data Integrity

    Glean some insights from the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).

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  • MasterControl Logo

    New European Med Device Regulation: 2020 Looms Large for Medtech Firms

    In 2020, the United States will hold a presidential election. Tokyo will host the Summer Olympics. For the medtech industry, the European Union’s Medical Device Regulation (MDR) will take effect. Politicians and athletes have been gearing up for 2020 and so should medical device firms.

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  • EU Policy 70 and Redaction — PleaseReview’s Take on It

    This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.

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