Compliance Considerations of Cloud-based Technology in the Pharmaceutical Industry

In April 2023, the Cloud Industry Forum released its annual report (“Breaking New Ground with Cloud”) showing that 95 percent of businesses across the public, IT and technology, financial services, retail, and manufacturing sectors were operating within the cloud. At least at that time, 55 percent of the organizations surveyed were operating in a hybrid […]

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Bridging the Gap: DEI in Life Sciences and the Impact of Executive Coaching

The life sciences industry, encompassing healthcare, biotechnology, and pharmaceuticals, is a bastion of innovation. Yet, as it strides forward, the industry must reckon with its past and present shortcomings in diversity, equity, and inclusion (DEI). Addressing DEI is not just about rectifying historical wrongs but is crucial for fostering a culture of innovation, trust, and

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Adios Ally McBeal Minis, Strip Clubs, and Cruises….

Pharmaceutical Sales:  Balancing Profit, Patient Care, and Integrity Pharmaceutical sales teams are now required to “know” and “follow” ECCP’s highly regulated requirements to ensure compliance and integrity.  The DOJ’s Criminal Division released an update to the use of personal devices, communication platforms, and messaging platforms.  All companies are required to have policies and procedures to

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The Role of Regulatory Compliance in Drug Commercialization Models

 Key considerations on the complex series of processes utilized to bring a new drug to market The average cost to launch a new drug has increased significantly in the last decade due to the rise in commercialization costs, more pressure from the payors, increased regulatory and compliance costs and shorter exclusivity periods. With returns on

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The Shifting Landscape of Data Privacy Regulation in the Life Sciences Industry

Strong momentum continues for the implementation and enforcement of state data privacy legislation in 2024, with Kentucky, Maryland, Nebraska New Hampshire and New Jersey enacting comprehensive data privacy laws in 2024. When combined with similar laws passed by various states in the prior year, there is a total of 17 comprehensive state privacy statutes that

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How to Sleep Better at Night: Navigating the Dangers of Drug Pricing

Drug pricing is a complex and complicated area for business executives to navigate. Thus, it is a significant source of concern and stress. Not only are there the challenges of setting prices at a level to cover development costs and return a reasonable profit, but business leaders must be mindful of the ever-increasing pressure to

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Drug Development and Compliance: 4 Ways AI is Impacting Pharma

The pharmaceutical industry traditionally faces challenges in drug development that are time-consuming, expensive, and error-prone. Artificial intelligence (AI) is revolutionizing this process, enabling faster drug discovery, more efficient clinical trials, personalized medicine, and improved regulatory compliance. AI’s strategic and ethical use promises safer, more effective drugs and enhances patient outcomes.

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Secure and Compliant: Mastering the ECCP Mandates in Pharmaceutical Sales

Secure and Compliant: Mastering the ECCP Mandates in Pharmaceutical Sales The pharmaceutical sector is navigating through an era where adherence to the Department of Justice’s (DOJ) Evaluation of Corporate Compliance Programs (ECCP) is intricately linked with advanced cybersecurity measures. This integration is pivotal in ensuring that pharmaceutical sales are not only compliant with legal standards

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Balancing Lives and the Planet: Ethical and Sustainable Healthcare Product Manufacturing

The pharmaceutical and medical technology industries wield immense power, safeguarding human health through life-saving drugs and devices. However, the manufacturing landscape is evolving.  The demand for ethical and sustainable practices has become paramount.  Fueled by the COVID-19 pandemic and a growing societal conscience, consumers increasingly expect products that not only improve lives but also minimize

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Navigating the Intersection of Ethics and Sustainability in the Pharmaceutical Industry

Navigating the Intersection of Ethics and Sustainability in the Pharmaceutical Industry Introduction: The pharmaceutical industry, characterized by its commitment to improving global health outcomes, is undergoing a profound transformation as it grapples with the intertwined challenges of ethics and sustainability. In an era defined by heightened social consciousness and environmental awareness, pharmaceutical companies are increasingly

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