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Article featured in European Biopharmaceutical Review: Harnessing automated content checking using technology that can compare and accurately spot and highlight anomalies – at high-speed across huge batches of content assets – can reduce the time taken to verify output by as much as 85%. Peter Muller explains this and other trends currently preoccupying biopharmaceutical organisations.
Article featured in Innovations in Pharmaceutical Technology: Forward-thinking companies are treating the current hiatus around IDMP as an opportunity to quantify the data preparation task ahead. Inevitably, organisations will need help to complete the groundwork, but they are not yet at a point where an all-encompassing product is possible. In any case, how content or data will ultimately be used is secondary at this point – the priority is ensuring that the data is correct, complete and clean.
Article featured in International Pharmaceutical Industry: The life sciences industry is in a state of flux for a whole series of reasons, which can largely be traced back to shifting market dynamics and growing regulatory rigour. In a conservative and inevitably slow-moving industry as this, it can be hard to keep up with the changes. This article explains the five biggest sources of disruption to pharma companies.
Article featured in European Pharmaceutical Manufacturer: The UK’s separation from the EU could have implications for regulatory harmonisation, and increase administrative workloads at a time when responsible teams are already overstretched and experienced talent is hard to find. Dr Jutta Hohenhörst of Schlafender Hase asks what impact this could have on IDMP preparations.
Article featured in the Journal for Clinical Studies: Life sciences technology vendors and consultancies are busy promoting Identification of Medicinal Products (IDMP) compliance solutions, which seems odd given that many details of the final requirements have yet to be published.
Article featured on Pharmiweb.com: How will Brexit and other challenges to the status quo affect plans to raise life sciences standards across Europe and internationally, asks Schlafender Hase’s Dr. Jutta Hohenhörst.
Article featured on PharmExec.com: If pharma companies want to hold their own in the current climate, they must embrace rather than resist market change. Schlafender Hase’s Peter Muller provides his analysis of five trends that threaten the status quo.
Article featured in the Journal for Clinical Studies: Bringing a new drug to market costs millions, so it’s highly risky to leave product labelling and packaging to chance. Especially if it’s expensive professionals giving hours of their time to these repetitive manual processes
Article featured in International Pharmaceutical Industry: Growing complexity in life sciences is raising the risk of product mislabelling, potentially putting lives in danger and leaving companies open to hefty fines and delays in product availability, warns Marc Chaillou of Schlafender Hase.
If you or someone you know is still doing manual proofreading, this is the perfect whitepaper! Regulations are increasing, and all regulatory hands need to be on deck. Companies can't afford to have highly qualified professionals manually proofreading material.
Article featured in International Pharmaceutical Industry: Regulators’ appetite for transparency and standards adherence is increasing. Their aims are to prevent manufacturers from misleading consumers, and to remove any risk of people overdosing on active ingredients
Article featured in Pharmaceutical Manufacturing and Packaging Sourcer: The line between pharma and food is blurring with the surge in nutraceuticals, and regulators are now playing catch-up. For organisations lacking a life sciences heritage, the stringent rules will affect all sorts of internal documentation processes.