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    E Pluribus Unum – The Future of Medical Writing

    Publication plans. Journal articles. Conference abstracts. Investigator brochures. INDs. NDAs. BLAs. MSL slide decks. Scientific platforms. Educational materials for HCPs. Talk tracks. Visual Aids. Patient Education Brochures. Leave Behinds. Objection handlers. Sales Aids. Posters, E-blasts. Focus groups. Advisory boards. Ask anyone in the pharmaceutical industry to identify a common thread among these and the answer will most likely lead to medical writing. Indeed, the ...
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    The new EU MDR and its impact on drug device combination products

    This article discusses the key elements of the EU MDR pertaining to drug device combination products and how life science companies can organize themselves to ensure regulatory compliance is met. The author will work through what manufacturers of these types of devices need to know in order to achieve EU MDR compliance as well as the challenges they could face and how to overcome them. The EU Medical Device Regulation (MDR) and the EU In Vitro Device Regulation (IVDR) i...
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    Three Ways to Save Time and Execute a Successful RIM Implementation

    With an increasing amount of pressure to get new drugs to market faster, biotech and pharmaceutical companies are under a constant time crunch to perform. This is true in every stage of the regulatory process, including the implementation of a new RIM system, which if not done strategically can worsen the inefficiencies that it was designed to improve. Watch this on-demand webinar to hear from two of Veeva’s subject matter experts, Lalana Dararutana and Serena Peirson,...
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    Preparing for successful meetings with the FDA

    Meeting with the FDA offers sponsors an opportunity to seek out critical feedback, provide background on their product and demonstrate the effectiveness of their studies. The right experience, preparation and planning is necessary to make the most of these meetings and help ensure a level of confidence with the FDA. Read on to learn about the three types of FDA meetings and gain insights for optimizing these opportunities. Read the full article>>
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    The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems

    In recent years, pharmaceuticals have become more complex, progressing from primarily small molecule drugs to an increasing array of recombinant proteins, monoclonal antibodies and cell and gene therapies. This has led to necessary changes in regulations to accommodate new, more complex manufacturing processes that have more steps and are more sensitive to variability and contamination. …. Read the full white paper