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PRIME vs. EU pathways: Strategy, global impact, and drug development insights

Comparing PRIME and EU Pathways: Long -Term Strategy and Global Impact

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In the European Union (EU), the European Medicines Agency (EMA) has implemented several expedited regulatory pathways, notably the PRIority MEdicines (PRIME) scheme, to facilitate the development and approval of promising medicines. Launched in March 2016, the PRIME scheme aims to enhance support for the development of medicines that target an unmet medical need. In addition […]

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impact of vitro diagnostic medical device regulation in EU

Understanding the Impact of IVDR on Precision Medicine Development in the EU

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The European Union introduced the In Vitro Diagnostic Regulation (IVDR), an elaborate regulatory framework intended to increase safety, performance and reliability of in vitro diagnostic (IVD) medical devices. Replacing its predecessor (IVDD), EU IVDR requires stricter requirements for compliance while placing greater emphasis on clinical evidence, risk classification and post market surveillance. Precision medicine, an innovative

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Current Trends patient engagement in healthcare

Patient Engagement in Healthcare: Current Trends and Future Opportunities

All Category, Blogs, Medical Writing, Pharmacovigilance /

For years, the focus of healthcare development and delivery has been on treatment and outcomes, often with limited input from patients. However, there is now a growing recognition that patients should not just be passive recipients of care—they should be active participants in their own healthcare journey. This patient-centered approach is transforming the way drugs

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Collaborating for Global Success in Advanced Therapy Medicinal Products (ATMPs)

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Advanced Therapy Medicinal Products (ATMPs) are transforming the medical landscape, offering revolutionary treatments for diseases that previously lacked effective solutions. These products include cutting-edge innovations such as gene therapies, somatic cell therapies, and tissue-engineered products. Despite their potential, ATMPs face numerous challenges—scientific, regulatory, logistical, and financial—that hinder their development and global market access. Addressing these

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personalized drug in development

Navigating the Challenges of Personalized Medicine in Development

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The landscape of modern medicine is undergoing a revolutionary transformation, with personalized medicine at the forefront. As we move away from the “one-size-fits-all” approach and embrace treatments tailored to individual genetic profiles, lifestyle, and environmental factors, the potential to improve patient outcomes has never been greater. However, this evolution also comes with unique challenges, particularly

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Role of Real-World Evidence in Post-Marketing Safety

Leveraging Real-World Evidence to Enhance Post-Marketing Safety Globally

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Real-World Evidence (RWE) refers to clinical evidence regarding the usage and potential benefits or risks of a medical product, derived from the analysis of Real-World Data (RWD). RWD encompasses information collected from various sources, including electronic health records (EHRs), insurance claims, patient registries, and data from mobile health applications. This evidence is crucial in understanding

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artificial intelligence in drug development and drug discovery

Regulatory Challenges and Opportunities with AI in Drug Development

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AI has emerged as a transformative force in drug development, promising to revolutionize how new therapies are discovered, tested, and brought to market. AI technologies are revolutionizing the pharmaceutical landscape. From hastening identification of potential drug candidates, to optimizing clinical trial designs and post-market surveillance – AI technologies are revolutionizing pharmaceutical innovation. AI technologies allow

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Collaboration to Prevent Drug Shortages in Healthcare

How Global Collaboration Can Prevent Drug Shortages in Healthcare

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Drug shortages are an escalating global challenge, threatening the effectiveness of healthcare systems worldwide. These shortages occur when the supply of medications—ranging from critical life-saving drugs to essential treatments—falls short of the demand. While drug shortages have long existed, recent events such as pandemics, geopolitical conflicts, and natural disasters have highlighted the fragility of global

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Concept of Patient-Centric Pharmacovigilance

How Pharmacovigilance is incorporating the concept of Patient Centricity – An Industry-Leading Approach

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In healthcare, assuring the safety of medications is equally as vital to developing innovative new treatments. Pharmacovigilance (PV), or “drug safety surveillance”, is the science of detecting, assessing, and preventing adverse drug effects or any related problems from drugs that has traditionally focused on data from healthcare providers, clinical trials and regulatory agencies. Development of

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Africa’s Healthcare Landscape in 2025

Evolution of Africa’s Regulatory and Healthcare Landscape

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Africa’s healthcare and regulatory landscape have transformed to reflect the commitment of the continent to improve public health and ensure the safety and efficacy of medical products. Understanding this evolution is important for pharmaceutical manufacturing firms and professionals seeking regulatory services to navigate the African market efficiently. Historical Context The history of health in Africa is

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