Articles

on 'Regulatory Guidance'

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  • Sound Advice

    This year, pharma regulators faced their own music

    Karen Langhauser, Chief Content Director
    12/26/2018
  • Regulatory Rewind

    A mix of the biggest hits from 2018

    Meagan Parrish, Senior Editor
    12/21/2018
  • An Injection a Day

    Premature promises about cell therapies create expectations ripe for disappointment

    Karen Langhauser, Chief Content Director
    12/03/2018
  • Bio's Bad Apples

    Can unproven therapies spoil the sector’s sweet success?

    Karen Langhauser, Chief Content Director
    11/23/2018
  • EU FMD: The One-Year Countdown

    Companies that manufacture, sell or dispense drugs in the European Union have until February 9, 2019 to comply. Where does the industry stand?

    Pharmaceutical Manufacturing staff
    02/08/2018
  • Reg Vision

    A painless look inside the most impactful regulatory trends and actions from 2017

    Karen Langhauser, Chief Content Director
    12/15/2017
  • Regulatory Intelligence Brief: 2017 FDA Overview

    All the major changes this year including guidance documents drafted and finalized, new legislation, other areas of interest and some tools to help you explore additional areas not covered herein

    Meredith Brown-Tuttle, RAC, FRAPS, Principal Consultant, Regulatorium
    12/12/2017
  • Keeping it Real – The Fight Against Fake Drugs

    With estimates of counterfeit drugs representing between eight and 15 percent of all medicines sold worldwide, pharmaceutical manufacturers need to stay ahead of counterfeiters

    Sean Riley, Senior Director, PMMI, The Association for Packaging and Processing Technologies
    05/19/2017
  • Identifying Contaminants in Pharmaceutical Manufacture

    In-process testing for contaminants is only as good as the methods used, so employing carefully developed and validated protocols is essential

    Gayla Velez, general manager, laboratory services, SGS Lincolnshire
    07/11/2016
  • Specifying Instruments to Meet Pharmaceutical Hygienic Requirements

    Industry standards help guide process instrument selection in pharmaceutical and biotech manufacturing environments, but further judgment is often required

    Ron Pozarski, senior industry manager, Emerson Process Management; and Emily Saopraseuth, product manager, Rosemount Pressure
    06/13/2016
  • MES Systems Help Facilitate Modern Regulatory Compliance

    Pharmaceutical manufacturers are eliminating the use of paper batch records in favor of electronic batch recording and Manufacturing Execution Systems

    Lars Hornung, senior director global sales, Werum IT Solutions GmbH
    06/09/2016
  • Managing Regulatory Inspections: A CDMO Perspective

    Inspection success begins with awareness of the challenges and obstacles, and continues with ongoing preparation and frequent inspection readiness

    Joachim del Boca, VP of Regulatory Affairs/Quality Compliance, Vetter Pharma-Fertigung GmbH & Co. KG
    05/06/2016
  • A New Day for Process Validation and Regulatory Review

    Drug Approval Strategies in the Age of Fast Track, Breakthrough Therapy and Accelerated Approval

    Tracy TreDenick, Head of Regulatory and Quality, David M. Fetterolf, Senior Consultant, Technical Operations and Michael Boyne, Senior Consultant, Analytical Services, BioTechLogic, Inc.
    04/11/2016
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