Introduction Clinical trial sponsors for pharmaceutical products (drugs and/or biologics for human use, medical devices, combination products etc) are required to provide the oversight for monitoring a clinical trial to help make sure that the rights, safety, and welfare of trial participants are protected. For this, sponsors are required to implement a system that manages […]
Risk-Based Approach to Monitoring Clinical Trials Read More »
Introduction The COVID-19 pandemic and changes in legal frameworks have sparked and accelerated the major trend of digitalization in the health sector. This trend is expected to result in merging digital products, including medicinal products and medical devices, into a digital ecosystem supported by shorter development cycles and technological progress. Digitalization is expected to improve
Digital Future of Healthcare Read More »
Technological disruptors are gradually revolutionizing various aspects of life sciences and healthcare. Software is slowly becoming an important part of products and are being integrated into digital platforms for medical and non-medical purposes. There are 3 types of software-related medical devices: 1) Software as a medical device (SaMD), 2) software in a medical device, and
Regulatory Guidelines for Software and Artificial Intelligence as a Medical Device Read More »
Introduction Malaria is one of the biggest and most pressing tropical and infectious diseases that pose a significant threat to public health- particularly children. In 2019, a study analysis found that malaria caused 643,000 deaths globally with children <5 years of age living in Africa and exhibiting the highest disease burden [1]. According to the
WHO Pre-qualification pathway: advancing access to vaccines Read More »
The European Medicines Agency (EMA) has created a sustainable network called DARWIN EU, which aims to generate real-world evidence to support regulatory decision-making in the European Union. This coordination centre network uses data analysis techniques and real-world interrogation methods to extract information and insights from various data sources, including structured and unstructured sources. Its main
DARWIN EU – Generating Real-World Evidence to Support Regulatory Decisions Read More »
IntroductionThe onset of the pandemic was one of the most hard-hitting events that impacted millions of people around the globe. On one hand it brought along life-changing repercussions and challenges that were first of many, but it also triggered industries to adopt innovative solutions in their everyday practices. One of these many solutions was instigating
Real-Time Remote Inspections – The New Normal Read More »
The healthcare sector has been significantly impacted by technology, with the rapid growth of digital health applications projected to continue due to increased demand for remote healthcare services, especially during the COVID-19 pandemic [1]. According to the US FDA, software-based medical devices are increasingly being used for diagnosing, treating, and monitoring complex diseases. The adoption
Rise of Digital Applications in the Healthcare Sector Read More »
In 1992 the US FDA established the accelerated approval pathway for drug development as treatment options for serious or life-threatening conditions like cancer based on the effect the drug has on surrogate measures or an intermediate clinical end-point that could predict the real endpoint. However, these investigational drugs are subjected to post-approval confirmatory studies which
Benefits of randomized control trials in accelerated approvals for oncology therapeutics Read More »
The pharmaceutical industry including its operations and associated functions run on data and content. Whether it is safety, regulatory, or clinical data, the pharmaceutical industry and all its stakeholders are actively involved in collecting, monitoring, evaluating, and exchanging crucial information. Indeed, the need for standardization of medicinal product information was highlighted in order to facilitate
Maintaining compliance with Identification of Medicinal Products (IDMP) standards Read More »
The development of biologic products has increased over the last few years in order to treat complex and serious conditions. These biologics, or innovator products, are approaching the end of their exclusivity period which warrants for the development of biosimilars to support timely access to alternative and more affordable treatment options for patients in need.
Biosimilars uptake – An upward trend Read More »
