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EU Biosimilar medicines can be interchanged

European Medicines Agency: Biosimilar medicines can be interchanged

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 […]

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Cardiovascular Medical Device Regulation in FDA

Overview on Cardiovascular Medical Device Regulation by the FDA

All Category, Blogs, Medical Device / development

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

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contraceptive better and safe family planning World Contraception Day

Increasing access to contraceptive implants for better and safe family planning

All Category, Blogs / development

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

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Steps of ICSR PROCESSING in PATIENT SAFETY

ICSR PROCESSING & PATIENT SAFETY

All Category, Blogs, Pharmacovigilance / development

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

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Pharmacovigilance Services in DDregpharma

Pharmacovigilance Services at DDReg: Our commitment towards Patient Safety

All Category, Blogs, Pharmacovigilance / development

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

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Medication errors: Self-medication

All Category, Blogs, Pharmacovigilance / development

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

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Understanding the EU Clinical Trial Information System

All Category, Blogs / development

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

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Treating Clostridium difficile infections using biotherapeutics

All Category, Blogs / development

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

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Incorporating plug in tools to facilitate regulatory publishing tasks

All Category, Case Studies, Publishing / development

Single bookmarking and hyperlinking tasks were conducted manually by regulatory publishing team members at DDReg which was a repetitive and time-consuming task. The key objective was to implement tools that would automate repetitive tasks to create a more efficient workflow for filing and e-functionality within the organization The regulatory publishing team at DDReg conducted deep

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Legibility checks to avoid ANDA rejection

All Category, Case Studies, Regulatory / development

A U.S.-based manufacturer had deficiencies in their abbreviated new drug application (ANDA) as it caused the U.S. FDA to Refuse to Receive (RTR) the ANDA. If additional material was submitted to correct the deficiencies, then the amended ANDA is considered a new ANDA submission and is subjected to pay a new ANDA fee. The manufacturer

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