This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
When events moved online, societies and associations recognised the wider access afforded by “virtual”, and now, as the world slowly gets back on track, many have opted for a hybrid model that offers the best of both. Here, we take a look at the top five takeaways from the document: 1. The same cannot be said for online events.
Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?
That’s according to the team at Sweden’s Sahlgrenska Science Park, who are getting ready to host a virtual event looking at how the specialisation of digital expertise is driving a trend of sector convergence that pharma is only just cottoning on to. Innovation versus regulation. For more information visit the Park’s website.
S erious adverse drug events are unfortunately common in hospitals and can occur across all stages of the medication delivery process. Right documentation. Engage the multidisciplinary team Involve the entire multidisciplinary team and foster trust and enthusiasm through regular communication, team building and cheerleading.
Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment.
In the event of inaccessibility, a business continuity plan should be in place including potential production risks and decision tree. Furthermore, there should be an evaluation of the cloud service provider to verify potential impact to product quality and/or data integrity in the event of inaccessibility.
’ You want to ensure that you document the attestation every time you dispense the at-home COVID tests for a patient. Giving your community access to these tests will help reduce uncertainty about what may be causing their symptoms. People don’t want to needlessly isolate themselves and miss work and life events.
Data loss if local servers are damaged or destroyed in a system outage, natural disaster, ransomware attack, or other loss event. For example, HTTPS should be used for encrypted communication between the web browser and the cloud application, and the system should be designed with multi-tenant architecture to isolate each customer’s data.
Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon. In this role, Graeme is responsible for all pharmacovigilance (PV) systems that facilitate adverse event data collection and reporting.
This person may go by other names in the document, depending on the state you live in. The benefits of a medical power of attorney Having a signed and notarized medical power of attorney offers many perks, and it is one of the most important documents you’ll create in a lifetime. A copy should also be shared with family members.
This document delves into the history of chromatography and clarification, addresses problems, proposes solutions, and offers a glimpse into what the future may look like after a revolution in biopharma production processing.
Organize and plan the work: identify who is going to do each task, specify the deadlines to deliver, estimate the available resources, and foresee how to react to possible unforeseen events. This strategy, and which test is susceptible to carry it out or not, must be set out in a document and this activity corresponds to the PM.
We are in the early stages of planning an event, PQA Convenes: Quality Medication Use in Rare Disease, which will bring our members and the rare disease community together to explore quality in medication use. This one-day event will take place on Thursday, November 7, 2024, in Arlington, Va., Learn more below.
The huge rise in the use of telemedicine services during lockdown has brought care directly to patients in their homes, while pharma’s communications with healthcare professionals (HCPs) has experienced a similar push to digital channels. About the interviewees. Joe Holmes – vice president of marketing services.
The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. Some of these challenges include for example regulatory compliance, quality control and effective communication between the original manufacturer and the CMO.
The online event also heard from Pfizer and patient advocate representatives and looked at how the NIHR’s collective approach allows life sciences firms to engage with patients while remaining aligned with ethics guidelines and codes of conduct – providing a UK solution to a global problem.
The framework conditions for this VUCA world have become more acute: Pandemics and geopolitical events are causing fragile and complex supply chains to collapse. and management communication strategy. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance? Information Systems DI Pharma 4.0™
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. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.
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.
To learn more about APQ Guides and other ISPE Guides, visit ISPE.org/publications/guidance-documents Learn More & Buy Meet the ISPE Staff: Tina Li In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. What do you love about your job?
While remote communication with HCPs rose in all countries in the same time period, not all remote engagement was the type likely to be described as meaningful – much of the volume was in emails, with WhatsApp, and other remote messaging, also important during the peak infection period.
Collaboration and community pharmacy To support this adaptation, ESOP places a strong emphasis on education. Its flagship event, the European Congress of Oncology Pharmacy (ECOP), was held in October 2024 in Lisbon and aimed to offer pharmacists a balance of expert scientific content and hands-on guidance.
By leveraging these events, you can get on the radar of employers early in the year. Apply the power of job crafting to create a new job after communicating your strategy for solving a problem in the firm. What does a successful job seeker do during the holidays? You lean into the holiday feel.
Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Software functions intended to display, analyse, or print medical information about a patient or other medical information (e.g.
Work-Life Balance For those of us who have spent years grinding through 12-hour shifts, missing family events, or feeling like life is just slipping by, remote work is a breath of fresh air. Medical writing, pharmacovigilance, clinical documentation, regulatory affairsthese fields are growing fast, and they dont require residency training.
Untreated hearing loss impacts every area of life—from talking with relatives and attending social events to day-to-day interactions like paying bills. Necessary documentation and information Financial assistance programs may require proof of income. However, hearing aids may be pricey. Among the 28.8
From technical expert panels, stakeholder advisory meetings, the measure endorsement vote and convening events focused on future measure opportunities, PQA members have the opportunity to be involved each step of the way! Additional details about this PQA Convenes event will be shared in the coming months.
In previous questionnaire-based analyses of clinicians responsible for fluid management – and with experience levels ranging from trainees to experienced clinicians – fluid management knowledge scores were low, and most participants reported having experienced unreported fluid-related serious adverse events.
This document delves into the history of chromatography and clarification, addresses problems, proposes solutions, and offers a glimpse into what the future may look like after a revolution in biopharma production processing.
ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong.
Generate leads by inviting professionals and non-experts to online events to discuss various topics and trends. Tell how your team participates in offline healthcare events such as conferences and presentations. In such an app, doctors can store documentation, track patient visits, provide instructions, and beyond.
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”
This document delves into the history of chromatography and clarification, addresses problems, proposes solutions, and offers a glimpse into what the future may look like after a revolution in biopharma production processing.
For example, important information may be locked in knowledge silos or gained through experience, making it difficult to find or document. When R&D teams can easily share and access key information across the enterprise, such as recruitment data or trial results, they improve communication and collaboration while avoiding duplicate work.
Provide answers to common queries such as appointment requirements, walk-in availability, duration, costs, required documentation, and operating hours. Email Marketing to Grow P OCT Email marketing enables direct communication with patients, fostering engagement and trust. Consistency is key.
Scale Member Management solution allows different types of managers to improve their cooperation, guide members through their journey, and improve health outcomes using a complete view of the customer, which provides relevant member information such as preferences, member plans, and health timelines showing clinical and customer service events.
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. Regions which were once the sources of raw materials may be plagued by adverse weather events, hindering production and causing inflated costs.
All I have is news reports including one of an internal CDC document. Perhaps you’ve read about data from Israel documenting effectiveness of only approximately 30-60% of the Pfizer vaccine against the Delta variant? This town hosted multiple events with large public gatherings that attracted thousands of out-of-town visitors.
For example, going “paperless” and moving all of the documentation to the cloud and keeping only electronic documents from now on can be considered a part of digital transformation. Communication platforms (e.g., This often means switching from usual solutions to new, more advanced ones. Digital Content Factory ).
Furthermore, these outputs can support communicating the functioning of the algorithm and how it is embedded in operational procedures in an audit situation. In this process, documentation regarding the decisions made is important to justify the model and explainability mechanism selection in an audit context.
Nature Communications 12, no. Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. Biotechnology Progress 36, no. 3 (2020):e2970. 34 Maschan, M., 1 (2021):7200. 35 Anguille, S., 36 Sterling, J. 22 March 2018.
Interim targets for end goals should therefore be set to challenge conventional “straight-line” planning (as shown in Figure 1), which will miss the end goal if some unforeseen event disrupts progress unless a heroic effort is made to recover performance (the so-called “hockey-stick” performance profile). Leave this field blank
And I'd like to make industry aware of a PIC/S document that's intended to guide inspectors on good data governance practices. It's worth noting that our host for this event, ISPE, also has a number of guides on data integrity that can be a source of information to facilitate compliance, as do many other organizations.
We organize all of the trending information in your field so you don't have to. Join 5,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content