Preparing for Crisis Communications in a Hyper-Connected World


When you work in healthcare, you are trained to expect a crisis whether it is a failed clinical trial, a life-threatening side effect for a marketed drug, or a decision by a government agency to require additional data before granting approval.  Professionals must understand how to prepare for these inevitable regulatory crises and the best ways to manage them.
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Change is in the Wind for Biopharma Deal Making


Through 2013 and the first half of 2014, the biopharma industry experienced a breakout year. The NASDAQ Biotechnology Index ended 2013 at a record high, with US investors embracing biopharma IPOs and follow-on financings at record levels. The total amount of capital allocated within M&A/licensing increased, and the bull market in biopharma continued its surge in the first half of 2014.
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Creating Sustainable Compliance Frameworks: Embedding Regulatory Compliance within Optimized Business Processes


This is the first of a series of articles that will examine several aspects of how biopharma companies can create more sustainable compliance frameworks. In order to create a culture where compliance is not an afterthought or added cost at the end of a process, companies need to think holistically about the people, process and technology implications of an environment where quality and compliance are truly embedded in the day-to-day operations. This article series will not only highlight key concepts but also provide project examples and lessons learned that can be applied to various situations.
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The Top Five Business Benefits of Compliance


Anyone reading this magazine understands the importance of compliance in preventing unethical conduct and violations of the law. U.S. pharmaceutical companies all follow the compliance program guidance from the Office of Inspector General of the U.S. Department of Health and Human Services on what constitutes an effective compliance program. We know the value of having a well-considered program in place to reduce the risk of prosecution or mitigate sentencing should a failure in compliance occur.
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Risk-Based Approach to Regulatory Compliance in Life Sciences – Beyond GxP Assessment


In an earlier column in this publication (“Risk-based Compliance Management – One Phrase, Many Interpretations”, November 15, 2013) I wrote about risk-based computer system validation (CSV) in pharmaceutical, medical device, and biotech companies and their providers. Here, I would like to discuss an actual project scenario as an example that demonstrates how a fresh look at CSV and risk management can redirect quality activities to ensure that risks are reduced and quality and compliance expectations are met. With the US FDA and other international regulatory agencies promoting the concept of risk-based compliance, companies are studying ways to implement harmonized and consistent risk-based CSV as an effective way to optimize the validation process and leverage downstream and upstream quality-related activities and documentation, such as software vendor testing or user data verification activities. [Read more...]

Software as a Medical Device


The rise in use of mobile platforms in today’s highly complex and technical healthcare systems has posed yet a new challenge for manufacturers, regulatory agencies and compliance officers. As technology has transformed from stationary devices to a new and evolving mobile environment, it has brought new challenges to not only the end users, but to the regulators – specifically the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). Both entities affirm the importance of these emerging mobile technologies to improve patient care and drive down increasing costs. However, there is some ambiguity as to how to properly regulate and monitor patient safety in relation to the use of software as a medical device.
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