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The regulatory decision comes as safety concerns emerge around the first therapy for the disease, an Apellis Pharmaceuticalsproduct. Izervay, a drug developed by Astellas Pharma subsidiary Iveric Bio, is now the second approved therapy for the degenerative vision-loss disorder geographic atrophy.
However, due to the importance of pyrogen testing for the safety of pharmaceuticalproducts , the report stated that this will help to drive market growth. Researchers propose novel test for pyrogen detection The post Drug safety driving pyrogen testing market expansion appeared first on European Pharmaceutical Review.
The process of giving a pharmaceuticalproduct a unique identity on the market is called pharmaceuticalproduct positioning. It entails recognising the special qualities and advantages of your product and conveying them to the intended market in a way that sets it apart from rival goods.
From the examination of raw materials through the release of the finished packaged product, Quality Control Authorities like Central Drugs Standard Control Organisation in India established under the Drugs & Cosmetics Act, 1940. They play a crucial role in assuring the efficacy and safety of products given to patients.
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.
According to researchers, a ribB -based colorimetric loop-mediated isothermal amplification (LAMP) assay could become a fast and easy-to-perform detection method for testing non-sterile pharmaceuticals for BCC. Burkholderia species are one of the primary causes of non-sterile pharmaceuticalproduct recalls and accounted for 45.3
Applying AI to GVDs Amassing comprehensive productand market-related data, GVDs demonstrate the value of a pharmaceuticalproduct to various stakeholders, including payers, healthcare providers, and regulatory bodies.
This can raise safety concerns for patients, due to important information not being present on the packaging, the report stated. The region’s “efficient production, distribution, and administration of pharmaceuticalproducts” is also pushing the demand for this packaging.
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.
Automated solutions, especially those aided by artificial intelligence (AI) , can enhance productsafety, the report noted. Pharmaceuticalsproduction lines are challenged by customised dosages and products such as pre-filled syringes. Popularity of injectables has also increased the focus on sterility.
Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. In August of 2022, Fresenius Kabi announced a three-year plan to add GS1 Data Matrix barcodes, also known as 2D barcodes, to its US pharmaceutical portfolio.
To address these issues, companies should adopt more advanced production strategies such as continuous flow chemistry, as they can shorten manufacturing processes, increase productivity and throughput. The result is efficient, cost-effective and high-quality (bio)pharmaceuticalproduction. principles.
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.
Freeze drying is a crucial technique to prolong the shelf life of pharmaceuticalproducts. Also known as lyophilisation, the technique stabilises and preserves sensitive products such as biologics, and diagnostic kits, in a permanently storable state.
Clinical studies play an essential role in determining the safety and efficacy of new drugs before they can be approved for the public. In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) regulates and ensures the safety, efficacy, and quality of pharmaceuticalproducts on the market.
By embracing early regulatory engagement, fostering collaboration, implementing agile practices, prioritising patient needs, and committing to continuous learning, pharmaceuticalproduct managers can successfully navigate this complex landscape, driving innovation while ensuring compliance and patient safety.
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?
It’s all about convenience, safety, and accessibility, especially for those who may not have easy access to physical pharmacies. As someone in the pharmaceutical industry, I’ve seen how this shift to online platforms is reshaping how people access healthcare. This shift is also reshaping how we think about trust in healthcare.
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.
Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceuticalproducts. They inform industrial scientists what is necessary to ensure that their product meets the safety and efficacy requirements to get a product approved in humans.
Plus, as these security assets are invisibly coded, they allow for prime packaging real estate to be spent on further safety information, representing a potential opportunity for greater awareness and education around falsified medicines. . Supply-chain visibility. A united front.
PharmaceuticalProduct Development Gen AI is a special tool for manufacture of new pharmaceuticalproducts. This helps healthcare organizations build their own smart assistants or search systems that answer any query in the most relevant and contextual manner.
More than 115 speakers from Europe and overseas will comprehensively report on current trends and changes in the field of pharmaceuticalproduction, quality assurance and quality control – both regulatory and scientific.
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.
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. There are several barriers that can negatively impact HTA and pricing outcomes, including uncertainty and trials that are not designed with the payers’ evidence needs in mind.
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.
The pharmaceutical industry is one of the most heavily regulated sectors due to the direct impact of its products on public health and safety. Several factors contribute to the stringent regulatory environment: Patient Safety: Ensuring that the pharmaceuticalproducts are safe and effective is a crucial aspect.
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. EXPLAINED: 5 KEY STRATEGIES TO IMPROVE PHARMA SOCIAL MEDIA MARKETING.
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. The patients are on maximum tolerated statins and they have predominantly atherosclerotic cardiovascular disease (ASCVD).
TRS 953 – Annex 2, Appendix 1: Stability testing of active pharmaceutical ingredients and finished pharmaceuticalproducts: Stability conditions for WHO Member States by Region. Injection Safety Fact Sheet. Novel functions and applications of trehalose. 2002;74 (7):1263–1269. Internet] WHO. cited 2023July]. Curr Med Chem.
Marketing efforts now extend to supporting these services, integrating pharmaceuticalproducts into telehealth conversations. Regulatory updates dictate how products can be marketed, ensuring transparency, safety, and compliance across campaigns. 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.
More convenience and safety? In order to succeed and grow, pharmaceuticalproducts and service providers must remain flexible and up-to-date with modern marketing and technology that supports, educates, and comforts their consumers. What’s not to love? Inside Sales & Affordable, Modern Pharma Marketing.
For starters, it's about customization to suit the specific nature of pharmaceuticalproducts. Temperature Control: Keeping Samples Safe For certain pharmaceuticalproducts, maintaining a specific temperature range is essential. This feature is vital to maintain the integrity of certain pharmaceuticalproducts.
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. Regulatory body – NMPA : all pharmaceuticalproducts sold in the Chinese market need to be granted market authorization by NMPA.
These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products. The post EMA publishes updated Q&A for ICH M10 appeared first on European Pharmaceutical Review.
Each strain was selected to take into account: the variability of environmental and human strains in a pharmaceuticalproduction environment strains known for their particular growth conditions, such as growth temperature, invasiveness, growth difficulties, etc (eg, Cladosporium , specific moulds, corynebacteria , Bacillus , etc).
The safety and efficacy of mRNA vaccines should be a game changer and is the likely solution to antibiotic-resistant microorganisms and emerging viral pathogens.” The other side is the pipeline of new pharmaceuticalproducts. About the authors.
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.
The warning letter to KVK-Tech underscores the FDA’s commitment to enforcing cGMP regulations and ensuring the safety and efficacy of pharmaceuticalproducts. The post FDA sends warning letter to KVK-Tech manufacturing facility appeared first on European Pharmaceutical Review.
But what does that billion dollars buy as far as approving the product for market? Under NO circumstances should any pharmaceuticalproduct be allowed into the market without complete and thorough testing. J&J received more than $1 billion from the U.S.
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.
This process is used to manufacture pharmaceuticalproducts with low molecular weights in large batches within a short timescale. ILC Dover’s single-use solutions are used with ArmorFlex® Films, which are proven to provide industry-leading performance, increase handling speed, and optimise safety during chemical synthesis processes.
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