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DDReg Pharma

Pharmacovigilance

Safety Testing of Allogeneic Cells used in Cell Based Medical Products

Cell based medicinal products use a single source of cells to treat multiple patients. For example, allogeneic cell therapies use donor cells to create a Master Cell Bank (MCB) that are then processed to be used in different kinds of therapies. The use of allogeneic cells to develop medicinal products and therapies demands rigorous testing […]

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Post-market safety data for underrepresented populations in clinical trials

Introduction Regulatory agencies require sponsors to collect and provide data on the safety and efficacy of drugs that they have obtained from clinical trials. In addition to age, gender, and racial subgroups, these trials should also incorporate data on patient populations that are historically underrepresented in clinical research. Indeed, information from a diverse patient population

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Technology Transformation

Technological transformation in Pharmacovigilance

Technological disruption is rapidly occurring across all industries. In the pharmaceutical industry, technological contenders are gradually transforming the landscape of drug development, clinical trials, and pre-clinical phases. Indeed, this holds true for pharmacovigilance and drug safety monitoring. Though the area of the industry is niche and highly regulated, hence the apprehension in incorporating technology in

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WHO Global Centre

The first global centre for traditional medicine: WHO Global Centre for traditional medicine in Gujurat, India

The 7th of April 2022 marked the 74th anniversary of the founding of WHO in 1948 which is celebrated annually as ‘World Health Day’. Each year draws attention to a specific health topic of concern to people all over the world. The onset of the pandemic has created history and has affected billions of people

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Health Behaviors

Integrative Medicine

Integral health integrates traditional treatment in a coordinated way with alternative medicine. Multimodal interventions, which combine two or more interventions such as conventional medicine, lifestyle changes, physical rehabilitation, psychotherapy and complementary health approaches in various combinations, with an emphasis on treating the whole person rather than, for example, one organ system, are also emphasized in

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Telehealth

Telehealth – Regulatory Perspective

The COVID-19 pandemic has forced healthcare systems to drastically and quickly rethink how they offer care. The unusually rapid spread of telehealth has been one of the most astonishing continuing trends. The pandemic may offer the impetus required to fulfill telehealth’s full potential. Nonetheless, there are fears that fast deregulation might jeopardize safety and privacy, despite

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Real World Evidence

Expanded use of RWE (Real World Evidence)

With a laser-like emphasis on results and value, healthcare is fast moving to a new world of patient choice. Indeed, healthcare systems that have historically emphasized medical treatments based on episodic interactions with patients are now realizing the need to fully comprehend external variables and provide ongoing care. Exogenous factors like genomics, conduct and social

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Artificial Intelligence

Artificial Intelligence – Impact on The Global Pharma Industry

One of the fastest expanding technologies on the planet at present is Artificial Intelligence (AI). It has been gaining so much popularity lately that even industry and sector have applications and use cases for it. Even from smart factories using AI to ramp up their production efforts, to the smart assistant in people’s smartphones, AI

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