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    The Expanding Role of Regulatory Operations: How Technology Advances Have Equipped Operations Teams to Play a New Strategic Role

    This article discusses the expanding function regulatory operations plays within organizations and how their broader responsibilities as process engineers, RIM systems experts and business analysts will play an increasing role in the organization's success. In the 1999 hit comedy Office Space , two consultants (the Bobs) are tasked with weeding out unproductive employees at a fictional software company, Initech. The Bobs kick off their interview of one Initech manager...
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    Transformation Underway in how Regulatory Information is Globally Managed

    This article discusses a new World Class Regulatory Information Management (WCRIM) standard and current industry status. Recent industry surveys have reported gradual increases in regulatory information capability (systems and processes) investment since 2007 with a dramatic leap over the past two years. Regulatory organizations are transforming how they work globally in an increasingly complex regulatory environment with the goal of improving efficiency and reducing c...
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    The Path to Successful Global Regulatory Operations: Document Management Processes and Technology Challenges

    This article discusses the process and technology challenges regulatory operation organizations face as they seek to operate globally and provides recommendations for how they can begin addressing them. As pharmaceutical organizations operate on an increasingly global scale, the regulatory operations function is being asked to perform at a higher level of effectiveness. For operating in multiple countries, often in collaboration with multiple partners, the development ...
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    European Regulatory Roundup: EMA to Waive Some Scientific Advice Fees for Accelerated Access Program (9 June 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Posts new Guidance on Changing Risk-Management Plans, Manufacturing Sites The European Medicines Agency (EMA) has posted new guidance on post-authorization changes to risk-management plans (RMPs) and manufacturing sites. EMA, which has adopted the policies in an attempt to simplify processes for marketing authorization holders, explained the implications of the guidance...
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    ISO IDMP: Another Compliance Project or a new way of Conducting Business?

    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. To support the continuous improvement of pharmacovigilance oversight within the EU, the European Commission (2012) has mandated pharmaceutical companies to submit product information according to ISO IDMP standards. 1 The standards are global and o...
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    Ethics and Risk Management: Lessons from the VW Defeat Device

    This article discusses risk management practices from the automotive industry and what the biomedical industry can learn from recent current events. Biomedical professionals are constantly reminded of ethics and risk management in all roles in the field. The financial impact of an organization failure can be nearly limitless when regulatory and/or legal risks are not mitigated through the quality system. As a profession, it is clearly understood biomedical innovations ...
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    New ISO 13485: Device Companies Have Three Years to Transition

    The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003. The new revision places a greater emphasis on QMS throughout the supply chain and product lifecycle, as well as device usability and postmarket surveillance requirements. Over the next three years, ISO 13485:2003 and ISO 13485:2016 ...
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    Practical Guidance for Regulatory Professionals on Combination Products

    This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities. Combination Products Combining a drug, device or biological product into a new product (frequently called a "combination product") continues to be an important and growing category of therapeutic products. Approximately one-thir...
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    European Regulatory Roundup: EMA Revises Conflict of Interest Rules for Board Members (21 January 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Adopts Strategy to Monitor Effects of Risk-Minimization Measures The Pharmacovigilance Risk Assessment Committee (PRAC) has implemented a strategy to enable it to measure the impact of its activities. Officials have designed the strategy to deliver feedback on the effectiveness of risk-minimization measures and other actions. PRAC, a part of the European Medicines Agen...
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    EMA Management Board Adopts New Framework for Industry Interactions

    The European Medicines Agency’s (EMA) Management Board has adopted a framework that seeks to streamline and structure industry-agency communications, as well as to increase transparency around those discussions. The framework , first announced in early October, comes as the agency has grown in size and scope to the point where its approach to managing interactions with industry have become fragmented. The interactions will cover areas of common interest for the agency a...
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    EMA Issues Recommendations for Veterinary Pharmacovigilance, Signal Detection

    The European Medicines Agency (EMA) has released a new set of recommendations for postmarket surveillance for veterinary medicinal products, which will go into effect on 1 October 2015. Background Pharmacovigilance is the process of monitoring the use of drugs after they have entered the market. For veterinary populations, regulators, companies and veterinarians are responsible for monitoring drugs and reporting suspected adverse drug reactions (ADRs). This information ...
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    Accessibility, Usability and Flexibility Critical for Regulatory Content Management

    The job of a regulatory professional has become increasingly global. According to RAPS' most recent Scope of Practice and Compensation Report , 72% of regulatory professionals in North America and Europe, have multiregional or worldwide scopes of work. There is a lot to keep track of in a large, global organization. Managing an organization's complex regulatory information and documentation across a global network of affiliates can be a significant challenge. ...