European Pharmaceutical Review

MAY 18, 2023

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.

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Documentation Communication 98

STAT

FEBRUARY 23, 2023

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…

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Communication Insurance Documentation 98

The FDA Law Blog

SEPTEMBER 24, 2024

These efforts included the adoption of a new review template for the assessment and documentation to be used in reviewing NDAs and BLAs with an overall goal of having a more collaborative inter-disciplinary approach to the process. Before FDA even asked, we had been considering an HPM FDA Law Blog post on this subject.

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IDStewardship

OCTOBER 14, 2024

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.

Documentation 130

Documentation Communication 130

STAT

APRIL 20, 2023

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.

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Documentation Patient Care 98

Hospital Pharmacy Europe

SEPTEMBER 24, 2024

The European Society of Cardiology Congress 2024 showcased the very latest in cardiovascular medicine and science with presentations and discussions about recent findings and new guidelines, as well as in-depth clinical teaching and education. FINE-HEART study findings were also presented at the ESC Congress.

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Documentation Hospitals Clinic Management Patient Care 52

ISPE

AUGUST 30, 2023

™ Steering Committee is proud to present Holistic Digital Pharma 4.0 Various case studies will be presented around formality, subjectivity, decision-making, and product availability. to help facilitate participants in developing a CCS using a case study and supporting documentation from an existing cGMP facility. The Pharma 4.0™

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Documentation Vaccines 98

ISPE

MARCH 3, 2023

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.

Documentation 98

Documentation FDA 98

IDStewardship

OCTOBER 28, 2022

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?

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Documentation 246

Hospital Pharmacy Europe

MARCH 6, 2023

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.

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Documentation Hospitals 98

Impact Pharmaceutical Services

SEPTEMBER 20, 2023

Results Syner-G reviewed a wide spectrum of documents to ensure compliance with respect to GMP requirements. The review of the documents included master and executed batch manufacturing records, batch related deviations, investigations, analytical data, validation reports and protocols. Significant improvement was observed.

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Documentation 40

The FDA Law Blog

NOVEMBER 11, 2024

Along with the proposed order, FDA issued as a supporting document the “ Scientific Review Supporting Proposed Administrative Order ” in which it describes the scientific data on the efficacy, pharmacology, and safety of oral PE underlying its determination to issue the proposed order.

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European Pharmaceutical Review

SEPTEMBER 2, 2022

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?

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Adverse Reactions Documentation Medical Schools Packaging 96

Viseven

JULY 10, 2024

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. As regulations evolve, medical writers must adapt quickly, updating documents and processes to maintain compliance.

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Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

PQA

OCTOBER 22, 2024

Strengthen requirements for the use of standardized health information technology for documentation of MTM services. Castora-Binkley wrapped the presentation by announcing the PQA MTM Advisory Group. PQA members can access the presentation slides on the Member Resource Library. Develop new performance measures for MTM quality.

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Process Improvement Documentation 52

ISPE

FEBRUARY 14, 2023

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Know the key topics.

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Documentation Communication 52

The FDA Law Blog

DECEMBER 4, 2023

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.

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Controlled Substances Documentation Dosage Prescription Filling 139

IDStewardship

AUGUST 17, 2022

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.

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Documentation 130

European Pharmaceutical Review

JANUARY 17, 2023

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’.

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Documentation 119

The FDA Law Blog

MARCH 7, 2023

Lack of compatibility with cloud-based document sharing. Creation of unnecessary documents. There is no option to reference a document that has already been attached elsewhere in the submission. This may result in the need to create additional documents that you may not necessarily need under the quality system.

Documentation 57

Documentation FDA Communication 57

pharmaphorum

SEPTEMBER 28, 2022

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.

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FDA Documentation 135

Viseven

JULY 25, 2024

This includes verifying the evidence presented, the research results, and even the factual information. Compliance documentation Compliance documentation, such as pharma regulatory guidelines for audits and reviews, standard operating procedures, reports, and records, should also be verified by an MLR team.

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Documentation Communication Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

SEPTEMBER 14, 2023

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.

Documentation 98

Documentation 98

pharmaphorum

OCTOBER 12, 2022

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.

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Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 100

ISPE

MARCH 30, 2023

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

Documentation 98

Documentation 98

Board Vitals - Pharmacist

JULY 3, 2024

A 40-year-old G5P4 presents at 24 weeks estimated gestational age for an ultrasound. The following complex, highly vascular mass was present on the placenta. A 58-year-old woman presents for a postoperative visit following a recent dilation and curettage conducted for postmenopausal bleeding. Her amniotic fluid index is 31cm.

Documentation 52

Documentation Immunization 52

Hospital Pharmacy Europe

FEBRUARY 1, 2024

‘As there have been significant changes, it is strongly recommended that all definitions are read and understood to assist in the interpretation of the standards themselves and the document should be read in full,’ the Standards’ introduction says.

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Documentation Hospitals Patient Care 52

pharmaphorum

MARCH 16, 2021

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”.

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Vaccines Documentation 135

pharmaphorum

NOVEMBER 15, 2021

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.”.

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Documentation Communication Hospitals 97

The FDA Law Blog

JUNE 27, 2023

FDA also requests a “detailed description of the allegation with any available supporting documentation.” In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission.

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FDA Documentation Labelling Communication 57

DiversifyRx

AUGUST 23, 2024

By accurately accounting for add-backs, you can present a clearer financial picture to potential buyers or investors, thereby increasing your pharmacy’s value and cash flow. – Owner Expenses: Owner expenses charged to the business, such as personal travel or entertainment, should be excluded to present a true financial picture.

Independent Pharmacies 52

Independent Pharmacies Communication Documentation Insurance 52

pharmaphorum

DECEMBER 30, 2022

The report also finds that the joint briefing document presented to the advisory committee did not adequately represent differing views within the FDA on Aduhelm. Moreover, additional informal meetings, telephone calls and emails were undocumented – contravening FDA’s internal recording policies.

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FDA Documentation Labelling 59

Viseven

SEPTEMBER 6, 2024

Key Principles of Data Integrity In the 1990s, the FDA developed a list of principles of data integrity, which still serve as a framework for working with data and documenting it. With contemporaneous data documentation, it becomes possible to easily avoid any errors and inaccuracies that might come up after data recordings take place.

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Health and Personal Care Stores Documentation Data Entry Pharmaceutical Companies 52

The FDA Law Blog

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. By Larry K. to be codified at 21 C.F.R. to be codified at 21 C.F.R.

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Controlled Substances Documentation Communication 52

Hospital Pharmacy Europe

AUGUST 17, 2023

11 Many documents and checklists detail every stage of the pathway in preparing CAR T. 12 The document aims to harmonise the implementation of hospital pharmacy CAR T services. 12 The document aims to harmonise the implementation of hospital pharmacy CAR T services.

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Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

European Pharmaceutical Review

NOVEMBER 15, 2022

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.”

Documentation 98

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

SEPTEMBER 29, 2022

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.

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FDA Documentation 99