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Challenge Syner-G was contracted by a US PharmaceuticalCompany to help improve the quality of submission documentation generated during the manufacture of a Drug Substance intended for Phase II trials. Results Syner-G reviewed each documentation and provided suggestions/comments/guidance to the CDMO to bridge the gaps observed.
It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication. As a specialized field, medical writing encompasses the creation of various documents, from regulatory submission documents to medical journal articles, that convey critical medical knowledge to diverse audiences.
In order to test, market, and release drugs onto the market, pharmaceuticalcompanies must abide by government regulations and oversight processes. . Regulatory affairs, however, encompasses more than just the pharmaceutical industry. Pharmacists who work in the private sector typically work for a pharmaceuticalcompany.
The pandemic has triggered a change in how pharmaceuticalcompanies are engaging with healthcare professionals. When IQVIA polled non COVID-19 treating Italian HCPs in March when the crisis was at its worst, it asked HCPs if they still welcomed pharmaceuticalcompany engagement during the crisis. The answer was yes.
Pharmaceuticalcompanies hold permission to market their products directly to consumers. The direct-to-consumer marketing companies for pharmaceuticals are increasingly moving online as it supports the digitisation of information, enabling patients to take control of their health.
Pharmaceuticalcompanies regularly transfer databases as they shift to new systems or change service providers in pursuit of higher quality and increased efficiency. Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon.
Promoting content worldwide When a pharmaceuticalcompany publishes content, it often considers the norms and laws of the country in which it operates. But what if this company decides to expand worldwide? Just a small error could lead to many people adhering to compliance documentation and making the same mistake in their work.
A 2020 survey from DrugsDisclosed.com of 3,346 users of prescription and over the counter (OTC) medicines from the UK and the Nordics revealed that: more than three-quarters of patients do not trust advice from pharmaceuticalcompanies about their medication; 81% feel the pharmaceutical industry influences prescription decisions; and.
“Commonly, BCBS requires proof of a diagnosis of Type 2 diabetes and documentation that the patient has not adequately responded to other diabetes medications before approving Ozempic,” he says. When BCBS covers Ozempic, the out-of-pocket costs will vary based on the drug tier it falls in.
Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. What are pharmaceutical medical affairs? . The role of medical affairs in pharmaceuticalcompanies.
Having previously spoken with Dr Mullen three years ago when she was country medical director for the UK & Ireland at GSK – on the topic of patient centricity and embedding that focus within the core of a pharmaceuticalcompany – our recent interview provided some interesting insights into the changing landscape of the industry.
Prospects of clinical dose companies in contract marketing. The demand for contract clinical dose marketing services from the pharmaceutical industry is on the rise as pharmaceuticalcompanies are concentrating more on saving their money and time as well as reducing the management burden by outsourcing marketing activities.
The surge in diseases is spurring demand for constructive treatment solutions, which is expected to boost the sales of injectable pharmaceuticalcompanies. The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing or hiring decision.
Pharmaceutical validation involves evaluating each manufacturing stage to ensure that predefined standards are consistently met. It also requires documenting the entire process, from raw material sourcing to product launch. Process design should be based on solid evidence and include thorough documentation.
The emergence of huge pharmaceuticalcompanies with discrete centres of excellence in geographically dispersed locations has upended the classic model of one-stop shopping for all development functions. Having a person in plant for some tech transfers facilitates higher levels of communication.
It's no wonder that global pharmaceuticalcompanies are increasingly sourcing innovation through alliances and partnerships with their peers in California. The sub-standard heights were discovered during the initial document review and site assessment.
The Advancing Pharmaceutical Quality, Quality Management Maturity Program includes five guidance documents: Corrective Action and Preventive Action (CAPA) : ICH Q10 demonstrates defined requirements for a robust corrective action and preventive action system throughout the product lifecycle. Internal Communication. CAPA Metrics.
Medical writing refers to creating healthcare-related textual content that aims to improve doctor-patient communication and provide insights on industry topics. Medical writers must be outstanding communicators, capable of breaking down complex ideas for the public and healthcare professionals in a digestible way.
On the patient-facing side, you can adopt wearable, connected devices or ePRO strategies for remote patient monitoring, to ensure the treatment team has well-documented patient information between visits, or you can delve into digital therapeutics. About the author.
Achieving effective communication between a healthcare specialist and a patient is impossible if data the healthcare provider relies on data that can be misunderstood, misinterpreted, and misused. If any piece of data is used after its documentation or creation, it’s crucial that it be attributed to the original source.
There was bipartisan support for the program at the hearing and support for measures such as requiring pharmaceuticalcompanies to publish their prices in a password protected site on HRSA's website. Four of the five staffers originally involved in the investigation now work for or lobby for the pharmaceutical industry.
Artificial intelligence (AI) has many implications for pharmaceuticalcompanies, including on research, drug discovery and development, manufacturing and trials. Colleagues with similar responsibilities and experience often work on the same team and may have limited communication with the rest of your organization.
Life sciences companies can adopt third-party software-as-a-service (SaaS) solutions for drug discovery or build custom tools in collaboration with a cloud provider. For instance, many pharmaceuticalcompanies use cloud-based platforms for remote research and development labs, regulatory compliance, and clinical trial data management.
Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. Technologies allow pharmaceuticalcompanies to collect and analyze a massive amount of data to ensure proper drug safety.
Data collection involved paper forms, diaries, and in-person interviews , which, while essential for documenting symptoms and outcomes, were prone to human error. Maintaining regulatory compliance required extensive documentation and oversight, while handling paper-based data was labor-intensive and prone to mismanagement.
Solutions for Pharma Enhance Patient Services solution allows pharmaceuticalcompanies to establish closer relationships with patients and providers using a single platform to deliver personalized engagement and support programs for better adherence with automated workflows. Salesforce Healthcare Benefits – Are They Real?
But before pharmaceuticalcompanies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. For example, important information may be locked in knowledge silos or gained through experience, making it difficult to find or document.
ChatGPT: “In a pharmaceutical software engineering context, data integrity refers to the accuracy, consistency, and reliability of data stored in computerized systems. This is a crucial aspect of pharmaceutical software as it directly impacts patient safety. ChatGPT : “The solution should be made to meet its desired quality standards.
The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. Automated systems offer a range of options for pharmaceuticalcompanies. Environmental monitoring is another important aspect of Annex 1.
The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels. What are the key points from the Guidance?
These standardised documents provide meticulously curated and scientifically approved information. 7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 percent as EU average with some Member States as high as 25 percent).
In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceuticalcompanies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.
A collaborative mindset must prevail between pharmaceuticalcompanies, suppliers, and regulators and include strategic partnerships that go beyond the pharmaceutical sector so we can move together to a more sustainable future. The risks are equally applicable to both privately owned and publicly traded companies.
For example, one pharmaceuticalcompany that switched to CM reported a 50% reduction in operating costs, a 33% reduction in waste, an 80% reduction in manufacturing and testing cycle time, and a 66% reduction in time from testing to release. 5 In addition, there are human elements to consider.
A pharmaceutical quality system (PQS) is a management system used to direct and control a pharmaceuticalcompany with regard to quality. Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials.” Press Release.
Indeed, a key aspect of EU GMP Annex 1 is the requirement for pharmaceutical manufacturers to develop a comprehensive Contamination Control Strategy (CCS) that documents their approach to assuring the sterile drug product’s high quality and, therefore, enhancing patient safety.
Pharmaceuticalcompanies and organisations get access to large amounts of data related to patients, clinical trials, and regulatory affairs. The companies help to design, develop and scale marketing strategies to effectively transition into a digitalised future.
Today, software companies know there is a growing market to meet demand for supply chain visibility platforms. The question for pharmaceuticalcompanies is how they can best deploy their data to make supply chains more efficient. Another important thing is that manual evaluations have been reduced to less than 0.5%
Of the world’s 20 largest pharmaceuticalcompanies, 17 have launched programmes tailored towards increasing medication access in low- and middle-income countries – up from just eight in 2010. Figure 1: Social media posts from pharmaceutical firms mentioning “environment”. A similar theme is evident in company filings.
In addition, several pieces of documentation will be required to support the API qualification, e.g. pharmacopeial compliance. It is also essential to evaluate the reliability of the company supplying the ingredient: do they provide sufficient communication and documentation? Is Benzalkonium Chloride a good choice?
Consent to begin “Informed consent documents are created to explain to a patient how a trial is going to be run, what they can expect, and the associated risks and potential benefits,” says Jill Balcerzak, Vice President of Global Solutions at content and translations solution provider RWS. The result?
In the dynamic global environment, the approval times for postapproval changes can be expected to change over time and may well differ between pharmaceuticalcompanies based on different practices and approaches. You may unsubscribe from these ISPE communications at any time. The proposals are consistent with WHO GRP.
In April, the pilot-level Nordic Pharmaceutical Forum (NPF) initiative, representing Finland, Iceland, Norway, Sweden, and Denmark, released an updated strategy document outlining the region’s plans to establish a joint procurement mechanism for medicines, with a declared focus on advanced therapy medicinal products (ATMPs) such as gene therapies.
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