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FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. 1 Simply, pharmaceuticalproducts are the most vulnerable to counterfeiting. 1 Simply, pharmaceuticalproducts are the most vulnerable to counterfeiting.
In turn, this impedes growth of the market because of the resulting delay in product approvals. The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor.
The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinalproducts.
However, for the pharmaceutical industry, the challenge is not as simple as just switching materials. An industry that is among the world’s biggest polluters is caught in a balancing act between satisfying the health and safety demands of industry regulators and meeting the needs of modern eco-conscious consumers.
Imagine getting your medicines delivered right to your doorstep, without stepping out of the house. It’s all about convenience, safety, and accessibility, especially for those who may not have easy access to physical pharmacies. Another growing concern is the rise of medicines sold on open marketplaces like Shopee, TikTok, or Facebook.
As the world now looks to a post-pandemic future, despite the counterfeit medicine trade showing no signs of slowing, industry bodies must come together to tackle the production and trade of fake products. This vicious circle is driving increasing demand for cheaper, less-regulated medicines.
Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. Fresenius Kabi is a global healthcare company specialising in medicines and technologies for infusion, transfusion and clinical nutrition.
Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile MedicinalProducts Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted. What were the most exciting innovations in pharmaceutical microbiology in 2022? About the authors.
Given China’s status as the world’s second most populous nation and an economic powerhouse, it represents both a monumental market opportunity and a dynamic arena of challenges for pharmaceuticalproducts. These medicines are considered essential because they meet key public health needs and tend to have low prices.
The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceuticalproducts.
Second, the production and delivery of CAR T cells necessitates close collaboration between the pharma industry and academic (usually transplant) departments. 10 Benefits of point-of-care CAR T-cell therapy Even after validation of the efficacy and safety of the therapy, two critical challenges remained – affordability and accessibility.
This highlights the importance of taking an individualized approach to medicine and considering a patient's unique medical history, current health status, and other relevant factors when prescribing medication. During my pharmacology class, I learned that there are no safe drugs, only safe patients.
It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceuticalproducts.
Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. What is the main recommendation you would make to the pharmaceutical/life science industry to ensure a strong data governance framework?
Payers must take into consideration not only the clinical efficacy of a drug, but also its safety profile, side effects, and cost-effectiveness, among other factors. According to Ross Selby, Head of Global Patient Access at Takeda Oncology via NICE : “Uncertainty is the prime reason that medicines struggle with HTA.
Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceuticalproducts. Trends in pharmaceutical contract packaging. The post Leading commercial packaging companies in contract marketing appeared first on Pharmaceutical Technology.
The pharmaceutical industry operates in a highly regulated environment, where marketing and advertising practices are subject to rigorous scrutiny. Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceuticalproducts.
One example of such a technology is that recently used to convert a commercial tetanus-diphtheria vaccine usually requiring refrigeration at 2-8°C into a room temperature product that is stable and fully‑protective in Guinea pigs after storage at 45°C for 7-12 months. Injection Safety Fact Sheet. 2002;74 (7):1263–1269. Internet] WHO.
ENSURE SAFETY. Make use of social media to promote safety and make people feel safe. Explain how various pharmaceuticalproducts affect the current condition and aid in the fight against infection. Companies are seeking any way to save money on medicine purchases, and they will gladly order products at a reduced cost.
That will be our pivotal trial for not just LDL lowering, but also for safety in Phase III, because it is a very large trial. Michael was the cofounding Chief Medical Officer of Omthera Pharmaceuticals in 2008. He received his BA and MS from Northwestern University and his MD from The Ohio State University College of Medicine.
Understanding Pharmaceutical Marketing Dynamics Pharmaceutical marketing dynamics are shaped by a myriad of factors, including the rapidly evolving healthcare landscape, technological advancements, and shifting consumer expectations. It should be clear, concise, and aligned with the brand’s overall mission and values.
They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. GlaxoSmithKline to plead guilty and pay $3 billion to resolve fraud allegations and failure to report safety data.
Precision Medicine Marketing: Drugs like Keytruda , designed for specific genetic profiles, have revolutionized treatment approaches. Marketing efforts now extend to supporting these services, integrating pharmaceuticalproducts into telehealth conversations. Rise of Telemedicine: Telehealth platforms are more popular than ever.
By understanding these strategies, stakeholders in the pharmaceutical industry can better navigate the complexities of promoting their products effectively. One of the primary objectives of pharma marketing is to communicate the benefits and safety profiles of medications to healthcare providers and patients.
With the introduction of a new CMC Intelligence entitlement to address post-approval changes, Clarivate now covers a broader range of the lifecycle of pharmaceuticalproducts. Future research could focus on developing PFAS-free packaging materials that meet regulatory standards without compromising safety.
A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceuticalproducts. The evolution of CCIT. Free Webinar.
Since then, there have been major advances in this field, including monoclonal antibodies (MAbs), other recombinant proteins, antibody drug conjugates (ADCs) and advanced therapy medicinalproducts (ATMPs), and considerably better understanding of product characteristics. November 2012. EMA/CHMP/ICH/425213/2011. 4 March 2020.
As you all know Trump has promised a vaccine shortly before the election while Secretary Azar barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.
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