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Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Under GDUFA III alone, DPD published 32 GDUFA guidance documents and MAPPs to ensure the successful implementation of GDUFA.
The study cohort included 670 patients who were diagnosed with PsA of at least a 3 month duration and have active plaque psoriatic skin lesions or a documented medical history of plaque psoriasis. READ MORE: Significant Knowledge Gap Exists in Patient Awareness of Psoriatic Disease The study found that 54.2% of patients who received placebo.
OctariusRx President and Consultant Pharmacist Victor Alves is presenting Pharmacy Documentation: Tips for Patient Safety and Survey Success at the ASCA 2025 Conference & Expo, April 30May 3, in Denver Colorado. He will discuss the essential elements of patient safety through complete pharmacy documentation.
1 With a complex interplay between patients’ skin and the diseases that impact it, PsD is a debilitating disease that presents physical, psychological, social, and economic burdens, leading to significant decreases in quality of life (QOL). of the population across the region,” wrote authors of the study.
Ctrl+F, but better Believe it or not, the reliable Ctrl+F command, cherished for bringing simplicity to document-searching, has been eclipsed by the advancements of AI. Ctrl+F can struggle with vague or common terms, making it challenging to find specific information in dense documents. No problem.
A wave of employee layoffs that UPMC announced last month was just one part of a broader restructure and operations “transformation” initiative, for which the nonprofit system has tapped management | An internal presentation obtained by Fierce Healthcare outlined April's “tough, but necessary" layoffs as one part of a broader look at the (..)
Part of it was the patients’ presentations: Some didn’t have the classic symptoms of the condition. LONDON — There was something odd about these Alzheimer’s cases. But it was also that the patients were in their 40s and 50s, even their 30s, far younger than people who normally develop the disease.
Digital transformation within the NHS offers significant opportunities to support patient safety and care, but it also presents challenges that need thoughtful consideration. In response to this, the Leeds Teaching Hospitals NHS Trust (LTHT) pharmacy team has recently launched its ‘Digital Induction’ document.
Despite a high prevalence of childhood and youth-aged obesity, the use of medications for treating obesity is persistently low among children and young adults (YA), according to an abstract presented at the American Diabetes Association’s 85th Scientific Sessions, held in Chicago, Illinois, from June 20-23, 2025. References 1.
This blogpost will summarize inspection topics for presenting digital CQV content and provide a list of common questions encountered during inspection events. Presenting this digital CQV content in inspection events requires a different set of presentation strategies than those needed for paper systems.
Here, the FDA investigators documented several instances in which the Quality Manager appeared directly responsible for preventing company employees from talking with FDA about their responsibilities or responding to direct questions from FDA about areas in which FDA has authority to inspect. FDA Guidance , at 8 (emphasis added).
OctariusRx President and Consultant Pharmacist Victor Alves is presenting “Medication Management: Acing your next Survey” at the 2022 Northeast Conference, presented by the Massachusetts Association of Ambulatory Surgery Centers. The post Victor Alves Presenting at the 2022 Northeast Conference appeared first on OctariusRX.
My presentation focused on safe medication management through complete pharmacy documentation. Speaking at the ASCA 2025 Conference & Expo, April 30May 3, in Denver Colorado was a great time. A special thank you Gina Throneberry, Director of Clinical and Educational Affairs for the invitation.
Develop a manual or guidance document outlining the goals of the account. This type of document is especially helpful for account management transitions in resident managed accounts. Multiple pharmacy organizations have guidance or best practice documents pertaining to social media use. Presentation to your peers?
It may be derived from work completed inthe microbiology lab, unitsdispensed from the pharmacy, administrations performed by nurses, expenditures produced from drug purchases, documentation within any area of the electronic medical record, extraction from supplemental tools or data warehouses, and so much more.
A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. To overcome these concerns, Pluta presents the process and documentation activities undertaken by one company.
For those involved in late-stage drug development and manufacturing, this tailored approach could present both efficiencies and new technical expectations, particularly in the areas of analytical characterisation and data justification. Document 9286/25. Brussels: Council of the European Union; 2 June 2025.
attorney general is specifically looking at “communications with AKF, documents relating to donations to the AKF, and communications with patients, providers, and insurers regarding the AKF.” ” The probe covers everything from January 2016 to the present day. Continue to STAT+ to read the full story…
Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.
Effortless document copying with “Edit in eWizard” Our team ensured version accuracy for the localization copy with the MLR-approved content item. Content creators can now be 100% sure that they are working on an approved version of the document without worrying about creating duplicates and accidentally working on an old version.
In a review of the documents, the BMJ said they showed concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production. According to the BMJ EMA scientists ensuring the manufacturing quality of the product found “truncated and modified mRNA species present in the finished product”.
A new document published by European Medicines Agency (EMA) makes ten recommendations and outlines good practices “to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.” Medicine shortages are a global health problem and are increasingly affecting European countries, according to EMA.
However, with the arrival of large language models like GPT-4, Bard, and LLaMA, there is growing enthusiasm for how AI might reshape the more mundane aspects of clinical practice: clinical documentation and electronic health records. And it’s obvious why. It really takes the feeling of care out of health care.
A new final guidance document that dropped today updates a 2019 draft guidance and clarifies the categories of clinical decision support software that would not be regulated by FDA as a medical device. “I O’Leary said.
The call for transparency in the presentation of study sampling methodology should not be limited to RMM effectiveness studies. The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. Any additional comments?
The Symposium program comprised a wide range of presentations and panel discussions on GMP-related topics, which included participation from Heads of Medicines Agencies, Heads of GMP Inspectorates, official PIC/S representatives and ISPE. He indicated that PIC/S participates in the ICH Q12 implementation Working Group.
Formulary Every insurance plan has a long document that shows how it covers each prescription medicine, called a formulary. Aetna’s many formulary documents show that Contrave (when it’s listed) often falls under non-preferred brands. Just present your SingleCare card at a participating local pharmacy and you’ll reap the discount.
Watson Elena Vulpe 3 March 2023 GAMP ® 5 (Second Edition) was published on 29th July 2022 and was presented and discussed at the 2023 ISPE Annual Meeting and at several local GAMP ® events held around the globe. Frank Henrichmann Heather D. Computer System Validation should not be a hindrance to innovation.
The document was commissioned by the Advanced Therapy Treatment Centres network’s Industry Advisory Group. Catapult presents vision for UK’s cell and gene therapy future. In March 2022, the CGT Catapult published the ‘National Cell and Gene Therapy Vision for the UK’.
12, 2012). “[W]hen the circumstances surrounding the presentation of a prescription would give rise to suspicion in a ‘reasonable professional,’ there is a duty to question the prescription.” Pharmacists and pharmacy management should pay heed to these prescribing red flags, resolve them when they appear and document their resolution.
I like when presentations and documents are sent in advance, but that is not always feasible. Another way to avoid surprises is to ensure key stakeholders have been given the chance to provide guidance and opinions on voting items ahead of time, so those can be considered in how the item will be presented and steered.
Given the value of essential oils for perennial allergic rhinitis, in the current study presented at AAAAI, the role of an essential oil nasal spray, which contained menthol, eucalyptol, thymol, camphor, birch oil, pine oil, cinnamon and mint, was evaluated over a period of 7 days by patients with seasonal allergic rhinitis.
Side note, I also have learners watch this video from CIDRAP-ASP which is a presentation by Brad Spellberg. Memorizing 45+ page document is certainly not a reasonable expectation, but one can certainly walk away with an awareness of general concepts and themes which are relevant.
Presentation of data is vital when regulators carry out formal inspections. Facilities can be asked to provide documented records of environmental monitoring, as well as personnel interaction with systems of record and the order in which events occurred.
It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop. Please check out FDA’s presentation on this very topic – Is My Product a Medical Device? See here for the slides, here for the recording of the presentation, and here for the transcript.).
Some AI websites to check out include Dall-E for images, ChatGPT or Google Gemini for text, Suno for music generation, Microsoft Copilot for document analysis, and Plus for presentations.
That’s why the GLSP document, which has been included in EudraLex Volume 10, is just as applicable in other markets, including the UK and US, as they are in the EU. “We The text, the structure of the text, and the presentation of data needs to account for a limited understanding.”.
Judge Mulrooneys prehearing ruling establishes the schedule for the parties presentations and established hearing guidelines. Parties will have ninety minutes to present the testimony of their witness. Consolidated parties are allowed to present testimony of up to two witnesses during the hearing, a presentation up to 120 minutes.
The FDA has issued multiple guidance documents over the past several years in an attempt to illustrate what is and what is not a medical device, what is subject to enforcement discretion, and what the FDA actively regulates. More information about this process may be found in FDA’s 513(g) Guidance Document. not a medical device, ii.
To this end, ISPE has collaborated with Biophorum to present their Digital Technology Roadmap, which builds upon the Digital Plant Maturity Model, to set out challenges and identify the key enablers for organisations to unlock the potential of digitalization. Greenfield facilities that have been the first to embrace the tools of Pharma 4.0
Wager 14 September 2023 With a recent increase in interest and participation, the ISPE GAMP® Special Interest Group (SIG) focusing on Manufacturing Execution Systems (MES) has mapped out an ambitious number of subject areas to use as the basis for future publications, presentations, and best practice guidance documents.
UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for software as a medical device (SaMD). Sheena Macpherson.
Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”
Managing and integrating data from heterogeneous sources — such as genomic sequences, clinical data, biological images and chemical structures — presents a complex challenge in terms of data normalisation. Additionally, GenAI enhances clinical trial design by identifying eligible patients and shortening recruitment times.
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