http://alantwhite.com/the-blogBLOG RSSFri, 10 Mar 2023 15:38:26 GMTFri, 10 Mar 2023 15:38:26 GMThttp://alantwhite.com/the-blog/apples-with-apples-why-true-value-in-outsourcing-is-more-than-just-priceIn today’s global regulatory and pharmacovigilance landscape, outsourcing is not just a practical necessity—it’s a strategic decision that can directly affect compliance, patient safety, and your reputation. Yet all too often, the selection process becomes skewed by one variable: price.But here’s the truth: a low bid rarely reflects the real cost—or the real risk.At Arriello, we’ve been called in many times to fix or take over projects where things went wrong after a price-driven decision.Tue, 15 Jul 2025 13:51:00http://alantwhite.com/the-blog/apples-with-apples-why-true-value-in-outsourcing-is-more-than-just-pricehttp://alantwhite.com/the-blog/ema-updates-guidance-on-drug-device-combinationsThe European Medicines Agency (EMA) has revised its guidance for medical devices used in combination with medicinal products. These updates, effective as of May 21, 2024, are based on the practical experiences since the implementation of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).Key changes include:Lifecycle Management: Enhanced clarity on managing the lifecycle of integral drug-device combinations.Labeling Requirements: New labelingTue, 04 Jun 2024 15:01:29http://alantwhite.com/the-blog/ema-updates-guidance-on-drug-device-combinationshttp://alantwhite.com/the-blog/title-the-importance-of-economic-realism-in-the-eu-pharmaceutical-regulations-reviewIntroduction:The European Union (EU) is a major player in the global pharmaceutical industry, with a market size of over €200 billion and a diverse set of regulatory challenges. The EU pharmaceutical review process, which aims to balance innovation, affordability, and safety, is a critical component of the EU's healthcare system. However, recent proposals to reform the process have sparked controversy, as some stakeholders argue that they could harm the competitiveness and economicSun, 30 Apr 2023 19:21:25http://alantwhite.com/the-blog/title-the-importance-of-economic-realism-in-the-eu-pharmaceutical-regulations-reviewhttp://alantwhite.com/the-blog/pharmacovigilance101This comprehensive guide explains everything you need to know about pharmacovigilance, the science of drug safety monitoring. Read on to discover how pharmacovigilance works, what its objectives are, and why it is crucial for public health.IntroductionPharmacovigilance is a critical aspect of drug development and post-market surveillance. It is a science that involves the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.Fri, 10 Mar 2023 15:33:00http://alantwhite.com/the-blog/pharmacovigilance101