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Integrative Medicine

What is Role of Integrative Medicine in Healthcare?

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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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Regulatory Affairs

Knowledge Management in Regulatory Affairs (KMRA)

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Knowledge Management Regulatory Affairs (KMRA) has been a recognized discipline in other sectors for over 20 years, but it has taken a long time for the biopharmaceutical business to debate and formalize it. When the ICH guideline paper Pharmaceutical Quality System: Q10 was published in 2008, it highlighted knowledge management as a major enabler of

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Telehealth

Telehealth – Regulatory Perspective

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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)

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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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AI in Pharma Industry

Artificial Intelligence – Impact on The Global Pharma Industry

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

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Biosimilars

Identification of Medicinal Products (IDMP) – The Perspective of US FDA & EMA

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IDMP is a progression of five specific guidelines established by the International Organization for Standardization (ISO) that emphasize different identification standards in the pharma industry. These standards establish an internationally recognized framework for uniquely identifying and describing pharmaceutical items, as well as for standardized documentation, coding and product information interchange across global regulators, manufacturers, suppliers

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FDA

Controlled Correspondence with FDA – An Update

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The US Food and Drug Administration (FDA) has recently finalized its guidance to generic drug manufacturers on how to seek drug development information through the controlled correspondence (CC) process. This guidance finalizes the draft guidance issued in Nov 2017 and replaces the finalized guidance issued in September 2015. This update on controlled correspondence with FDA

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Nitrosamine impurities

Nitrosamine Impurities: A Regulatory Perspective

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In July 2018, the European medicines regulatory network became aware of the presence of nitrosamine impurities in an Active Pharmaceutical Ingredient (API). This was the first time that a nitrosamine impurity had been detected in a pharmaceutical drug. The unexpected delivery of these impurities resulted in voluntary product recalls on a mass scale and led

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