Arthritis is an inflammatory condition that affects people worldwide leading to disabilities and decreasing the quality of life. Rheumatoid Arthritis (RA) is the most prevalent inflammatory arthritis that has triggered a revolution of treatment options over the last few decades. Though there is currently no cure for the condition, treatment regimens focus on alleviating symptoms, […]
A biosimilar medicine is one that demonstrates high similarity to another biological medicinal product that has already been approved- this is also known as the ‘reference product’. Interchangeability refers to using one medicinal product instead of another provided the therapeutic intent is the same. In this context, interchangeability is the medicinal product being substituted by
European Medicines Agency: Biosimilar medicines can be interchanged Read More »
According to the World Health Organization (WHO), cardiovascular diseases (CVD) are the leading cause of death around the world. In 2019, nearly one-third of all global deaths were attributed to CVD-related death; 85% were as a result of stroke and heart attack (1). Over the last few decades, cardiovascular devices have emerged as an important
Overview on Cardiovascular Medical Device Regulation by the FDA Read More »
Access to contraceptive options for reproductive health helps women in achieving their reproductive goals by allowing them to plan and have safe pregnancies. Spacing pregnancies is beneficial for maternal health and allows women to pursue other priorities such as education or work. In developing countries, maternal morbidity and mortality rates are relatively high and evidence
Increasing access to contraceptive implants for better and safe family planning Read More »
Adverse event processing & causality assessment is the preferred way to identify a drug product related risk and its association with patient safety. An Individual Case Safety Reports (ICSRs) is an important source of information that contains crucial data on an adverse event that a patient is experiencing when taking a drug. The purpose of
ICSR PROCESSING & PATIENT SAFETY Read More »
An important aspect of patient safety is Pharmacovigilance, that is the science and activities relating to the Detection, Assessment, Understanding, and Prevention of adverse effects or any other medicine-related problems. As an end-to-end pharmacovigilance services provider, DDReg is a key stakeholder in the drug safety spectrum and is committed to ensure utmost patient safety. Our
Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety Read More »
Florence Nightingale once said “The very first requirement in a hospital is that it should do the sick no harm” 1 This notion has been evolving ever since to provide utmost patient safety in the healthcare processes. Studies have emphasized that medication errors are one of the principal causes of adverse events in patients constituting
Medication errors: Self-medication Read More »
The European Union (EU) implemented significant changes in the way clinical trials (CTs) are conducted where the EU Clinical Trial Regulation (EU CTR) (Regulation EU 536/2014) came into effect early this year, on 31st January 2022. The aim of the new regulation was to harmonize how clinical trials are supervised and assessed by enhancing collaboration
Understanding the EU Clinical Trial Information System Read More »
Treating Clostridium difficile infections using biotherapeutics Biotherapeutics are therapies that are essentially based on isolating large molecules of proteins, produced by live organisms, engineered to prevent, treat, and cure various disease conditions, instead of chemically synthesizing drugs in the laboratory. Patients across the globe have benefitted from the use of biotherapeutics to treat various disease
Treating Clostridium difficile infections using biotherapeutics Read More »
In a technology driven era where businesses are increasingly incorporating advanced information and data management tools into their operations, the risk of facing cyber attacks and breaches is also increasing. Additionally, businesses face non-compliance in regulatory and legal requirements when handing information security, and so the demand for transparent information security is on the rise-
Why is an ISO 27001 important for an organization? Read More »
