pharmaphorum

MAY 25, 2022

Here, we take a look at the top five takeaways from the document: 1. Companies should still clearly document their reasons for supporting events, including virtual and hybrid international congresses, said the document. The codes still apply. End of the host country. Follow the path of most resistance.

Documentation 100

Documentation Communication Labelling 100

IDStewardship

SEPTEMBER 2, 2022

In this article an expert in clinical information design provides his insights, discussing reasons why some guidelines do not get used along with solutions to these problems. Article Posted 2 September 2022. CMS also mentions guidelines several times in their 22-page document on new antimicrobial stewardship requirements for hospitals.

Hospitals 130

Hospitals Documentation Formulary Information Medication Guidelines 130

European Pharmaceutical Review

JULY 7, 2022

In an article published in the Journal of GXP Compliance , Moldenhauer explained what can be learned from the observations for a vaccine production facility published in a redacted FDA 483 Report as an example. One cannot just assume that a repair has no effect on the production,” with the rationale for change and impact decision documented.

Documentation 97

Documentation Vaccines FDA 97

IDStewardship

MAY 12, 2023

In this article five tips for incoming PGY2 pharmacy residents is provided. BCPS, BCIDP Article posted: 12 May 2023 The ASHP pharmacy residency match phases 1 and 2 have come to a close. Core resources can include society guidelines, ACCP Self Assessment Program chapters , review articles, key specialty books (e.g.,

Communication 130

Communication Documentation Vaccines 130

European Pharmaceutical Review

DECEMBER 21, 2022

Therefore, characterisation of the microorganism(s) is of utmost importance to LBP quality documentation. This article proposes a tentative approach for a minimum standard requirement for the WGS and bioinformatics analysis of LBPs. Download and read more now… .

Documentation 102

Documentation FDA 102

pharmaphorum

JULY 14, 2022

Instant messages should be recognised as EU documents under transparency rules, and recorded and made available for freedom of information requests. Instant messages should be recognised as EU documents under transparency rules, and recorded and made available for freedom of information requests. Full list: [link].

Documentation 52

Documentation Vaccines 52

European Pharmaceutical Review

JULY 10, 2023

The assessment report of the Committee for Medicinal Products for Human Use (CHMP)’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products offers guidance and recommendations on mitigation and prevention of nitrosamine-contaminated human medicinal products.

Documentation 96

Documentation FDA 96

Hospital Pharmacy Europe

JUNE 8, 2023

In the absence of transparency, he felt that both the pre-publication reviewers and those reading the final published article would not be aware of any retrospective protocol modifications and thus be unable judge the reliability of the final results. Later work simply re-affirmed this finding.

Documentation 52

Documentation Communication Patient Care Hospitals 52

IDStewardship

APRIL 13, 2023

In this article an infectious diseases pharmacist with experience managing antimicrobial stewardship programs discusses antimicrobial stewardship regulatory standards Authored by: Timothy P. Gauthier, Pharm.D., difficile infection, adverse effects, antibiotic resistance, hospital costs, and hospital length of stay.

Hospitals 236

Hospitals Documentation Communication Patient Care 236

ISPE

SEPTEMBER 8, 2023

This article outlines ISPE task teams created reports and a model to examine the challenges surrounding drug shortages, emergency preparedness, and the supply chain of active pharmaceutical ingredients (APIs). This article outlines these initiatives. What do you love about your job?

Documentation 91

Documentation 91

pharmaphorum

JUNE 3, 2021

This article appears in our digital magazine Deep Dive: Market Access 2021. And anyone interested in a game of policy bingo will be able to mark off all the important policy documents and every agency too. Leela Barham takes stock. Read below for a preview: NICE has never stood still since it started its work in 1999.

Documentation 96

Documentation 96

European Pharmaceutical Review

JULY 17, 2023

New research published in JAMA Health Forum has documented that the US National Institutes of Health (NIH) spent $8.1 billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. This was ~10 percent of reported industry spending.

Documentation 86

Documentation FDA 86

The Honest Apothecary

MAY 5, 2023

In a Forbes article on this topic the author observers “Day-to-day failure to follow through is costing managers long-term credibility with their employees. Fixing Bad Follow-Through The first step to fixing poor follow-through as a leader is to, beginning today, document everything you are expected to do in writing. That is it.

Documentation 100

Documentation 100

European Pharmaceutical Review

SEPTEMBER 2, 2022

This article explores just one aspect of the RMP, that of RMMs, and how their effectiveness is measured with Dr Sophie Jouaville, an associate principal at IQVIA working on the design and oversight of non-interventional real-world evidence (RWE) safety and health economics and outcomes research (HEOR) studies.

Adverse Reactions 76

Adverse Reactions Documentation Medical Schools Packaging 76

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. 11 This requirement directly contradicts what is included in Article 63. Article 63 EMA (29 January 2020). Article 63 Euractiv (26 September 2023). Article 63 PGEU (2023). European Commission (26 April 2023).

Packaging 84

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 84

Pharmaceutical Technology

JULY 19, 2022

In total, the frequency of sentences related to cloud computing between April 2021 and March 2022 was 133% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,422 sentences, 19 (1.3%) referred to cloud computing.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 98

Hospital Pharmacy Europe

APRIL 25, 2024

Workplace environments must support ‘psychological safety and [enable] individuals to feel confident, supported and empowered to speak up and raise patient safety incidents without fear’, the document added. A version of this article was originally published by our sister publication The Pharmacist.

Community Pharmacies 52

Community Pharmacies Hospitals Documentation 52

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. This article primarily discusses Appendix D5 Testing of Computerized Systems and Appendix M12 Critical Thinking. The GAMP 5 Second Edition includes: Six completely new appendices.

Documentation 86

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 86

IDStewardship

AUGUST 17, 2022

In this article tips for running successful meetings as a pharmacist are provided and discussed. . Article posted 21 August 2022. I like when presentations and documents are sent in advance, but that is not always feasible. Authored By: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP.

Documentation 130

Documentation 130

Hospital Pharmacy Europe

NOVEMBER 2, 2023

To support the documents, in spring 2024 the RPS will launch a Greener Pharmacy Toolkit, allowing pharmacies to self-accredit their sustainability status. A version of this article was originally published by our sister publication The Pharmacist.

Hospitals 52

Hospitals Community Pharmacies Documentation Communication 52

Fuld

NOVEMBER 13, 2023

Each article provides a concise, strategic viewpoint designed to inform and guide your business decisions. Practicing War Games at UC Irvine’s business school AI is transforming the private equity deal lifecycle, from document review to data analysis.

Documentation 52

Documentation 52

pharmaphorum

JANUARY 28, 2022

The messages were requested via a freedom if information request by journalist Alexander Fanta of netzpolitik.org, who was following up an article in the New York Times last year which suggested “personal diplomacy” had played a big part in the EU’s order for 1.8 billion doses of Pfizer and BioNTech’s vaccine.

Vaccines 62

Vaccines Documentation 62

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.

FDA 91

FDA Documentation 91

The Checkup by Singlecare

FEBRUARY 15, 2024

This article will focus on how dogs function as service animals, including the health benefits they provide to their owners and how you may qualify for one. This definition extends to those with a documented history of such an impairment, even if they are not presently experiencing a disability. What is a service animal?

Health and Personal Care Stores 98

Health and Personal Care Stores Documentation Grocery Stores Hospitals 98

Hospital Pharmacy Europe

DECEMBER 11, 2023

The exception to this is aseptic facilities, where the extensive post-registration training carried out by parts of the pharmacy technician workforce makes them equally as qualified as some pharmacists to supervise these facilities,’ the document said.

Hospitals 52

Hospitals Documentation 52

pharmaphorum

JANUARY 18, 2022

POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements. Overview of the workshop: The workshop is aimed to provide an introduction to the key elements of the Medical Device Regulation that Companies affected by article 117 need to consider. Understand and be able to interpret the requirements of Article 117.

Packaging 52

Packaging FDA Documentation Vaccines 52

Pharma Marketing Network

MAY 3, 2023

Narrative review: the promotion of gabapentin: an analysis of internal industry documents. This article was produced with the assistance of artificial intelligence. University of California Press. Steinman, M. Landefeld, C. S., & Bero, L. Annals of Internal Medicine, 155(1), 43-53.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

Hospital Pharmacy Europe

SEPTEMBER 26, 2023

The PSA had previously raised concerns relating to FtP cases, including timeliness, transparency and clarity of the initial assessment and investigation process, decision-making, ensuring parties were supported to participate in the process and the way risk assessments were documented.

Documentation 105

Documentation Hospitals 105

Pharmaceutical Technology

JULY 12, 2022

In total, the frequency of sentences related to digitalization between July 2021 and June 2022 was 400% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,091 sentences, eight (0.7%) referred to digitalization.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

JUNE 28, 2022

In total, the frequency of sentences related to robotics between April 2021 and March 2022 was as frequent as in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,422 sentences, six (0.4%) referred to robotics.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 52

The FDA Law Blog

FEBRUARY 27, 2023

This error has appeared not just in articles and other news publications but in some court documents as well. Gilbert — One misnomer that has been repeated over the years has been the reference to the “Drug Enforcement Administration” (“DEA”) as the “Drug Enforcement Agency.” The DEA has even made the same mistake.

Documentation 45

Documentation Controlled Substances FDA 45

Board Vitals - Pharmacist

APRIL 22, 2022

Physicians can read a peer-reviewed article planned as a learning activity and certified for credit by an accredited CME provider before publication. This includes a critical review of an assigned journal manuscript or featuring an article within a peer-reviewed, professional journal. Journals . Internet Searching and Learning .

Documentation 52

Documentation 52

Pharmaceutical Technology

AUGUST 9, 2022

In total, the frequency of sentences related to artificial intelligence between July 2021 and June 2022 was 400% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 2,465 sentences, 24 (1%) referred to artificial intelligence.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

pharmaphorum

MAY 26, 2022

For example, after the beginning of the full-scale war in Ukraine, DrugCard found an article in the medical journal “Pharmacology and drug toxicology” describing a clinical case of acute poisoning caused by an overdose of acetylsalicylic acid and other drugs taken by a girl for committing suicide.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

The deprescribing.org Blog

FEBRUARY 17, 2021

Recently the Canadian Journal of Hospital Pharmacy (CJHP) published an article where the question “Should hospital admission be used as an opportunity for deprescribing in older adults?” Q: What were your initial thoughts when you read this article? The ‘cons’ side of this article really struck a chord with us.

Hospitals 52

Hospitals Documentation Communication Patient Care 52

pharmaphorum

APRIL 7, 2021

The document says blood clotting cases for both the AZ and Janssen-Cilag jabs will be assessed, along with a possible signal of capillary leak syndrome with Vaxzevria. It also emerged this week that the EMA is planning a separate investigation into the Russian Sputnik V vaccine, although that isn’t looking at safety.

Vaccines 52

Vaccines Documentation Hospitals 52

DiversifyRx

NOVEMBER 24, 2023

If you think that doesn’t happen nowadays, here’s an article about recent counterfeit HIV medications. This record-keeping includes detailed documentation of the product’s history and movement through the supply chain. Document Everything Meticulous record-keeping is a fundamental aspect of DSCSA compliance.

Independent Pharmacies 52

Independent Pharmacies Packaging Documentation FDA 52