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 service 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- particularly
Why is an ISO 27001 Certification Important For an Organization? Read More »
Managing regulatory information for a pharmaceutical product along all stages of its life cycle is a key challenge in the pharmaceutical industry. Now, as more opportunity markets emerge bringing their own stringent regulations and changes in previous regulations, managing regulatory information is becoming increasingly complex which can delay market access for products. Furthermore, information is
Role of Regulatory Information Management Systems -RIMS Tools in Asia Market Read More »
The pharmaceutical industry is highly regulated using legislations and regulations that bring together administrative, technical, and legal information about a medicinal product. These can be a combination of guidelines, procedures, policies, etc., that pharmaceutical organizations must adhere to, or follow, to get market approval for their products. This way, governments and their relative health authorities
Role of Regulatory Affairs in the Pharmaceutical Industry Read More »
Drug laws & regulations in India have roots that are almost 80 years old. India still follows drug laws that were framed in pre-independence time through Drugs & Cosmetics Act – 1940 and Rules 1945. The laws & rules have frequently been amended to address the challenges posed by Indian pharma Industry. However, the basic
India’s New Drugs, Medical Devices and Cosmetics Bill 2022 Read More »
The pharmaceutical industry is one that is constantly growing and simultaneously facing challenges in Quality Management Maturity Program in US FDA. The onset of the pandemic has brought new obstacles that require immediate attention and innovative solutions. Quality assurance (QA) is a routine measure that ultimately ensures patient safety by making sure all pharmaceutical products
Quality Management Maturity Program by the CDER of the U.S. FDA Read More »
