European Pharmaceutical Review

JANUARY 2, 2024

While advantages to the Quality by Design approach is clear and practical implementation of Quality by Design is encouraged by publication of public guidance documents ICH Q8(R2) – ICH Q14, the industry has not yet fully embraced the QbD approach in Marketing Authorisation Applications (MAAs) for European market approval, the authors noted.

Drug Development 105

Drug Development Biosimilars Documentation 105

ID Stewardship

MARCH 17, 2024

In this article a clinical pharmacist with experience and knowledge about using artificial intelligence describes how it can be used to be a better clinical pharmacist. BCIDP, BCPT Article Posted 18 March 2024 In healthcare’s evolving landscape, artificial intelligence (AI) promises to redefine pharmacy. No problem.

Documentation 135

Documentation Doctor of Pharmacy 135

Pulses

JANUARY 26, 2023

and I have written an entire article about it. Additionally, natural language processing (NLP) tools can detect patterns in text and documents, allowing for deeper understanding of topics that may have otherwise been missed. It is now 7:31 a.m. To be completely honest, I only wrote this paragraph and the last two. That’s the point.

Documentation 52

Documentation 52

European Pharmaceutical Review

JULY 1, 2022

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.

Documentation 105

Documentation Pharmaceutical Manufacturing 105

European Pharmaceutical Review

FEBRUARY 22, 2023

Key features of the PDA TR 90 report The document addresses the evolution of contamination control principles towards a holistic approach. The document has 14 sections and five appendices. Ultimately, the new CSS document can help the pharmaceutical manufacturing sector to develop and implement a successful CCS.

Documentation 98

Documentation Pharmaceutical Manufacturing 98

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 105

Documentation Communication Pharmaceutical Manufacturing Labelling 105

European Pharmaceutical Review

AUGUST 25, 2023

According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. The document highlights that the revision should also consider related changes in other GMP chapters and annexes as well as in other regulatory documents. What is included in the new revision?

Documentation 98

Documentation Pharmaceutical Manufacturing 98

ALiEM - Pharm Pearls

APRIL 5, 2023

Does this come at the expense of your documentation? What is your method for reviewing learners’ notes and how do you provide feedback on documentation? I usually text them if it’s after shift, or talk to them on shift about their documentation. What is your favorite book or article on teaching? Definitely.

Documentation 130

Documentation Hospitals 130

ALiEM - Pharm Pearls

MARCH 8, 2023

Does this come at the expense of your documentation? It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet. It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet. What is your favorite book or article on teaching?

Documentation 147

Documentation Hospitals 147

Express Pharma

JULY 11, 2024

It also streamlines creative and video transformation while effectively engaging healthcare professionals (HCPs), patients and payers Future-ready medical content value chain: Generative AI capabilities are revolutionising the medical content value chain.

Documentation 105

Documentation 105

ID Stewardship

OCTOBER 28, 2022

In this article a PGY2 Infectious Diseases Pharmacy Resident discusses social media as a resource for pharmacy residency recruitment, providing insights for both programs and candidates. . Article Posted 28 October 2022. While I strongly recommend reading the article, below are a few of the key takeaways. Authored by: Hunter O.

Documentation 98

Documentation 98

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 111

Documentation 111

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 98

Documentation 98

Pharmacy Joe

APRIL 26, 2023

In this episode, I’ll discuss an article about IV push piperacillin-tazobactam. Subscribe on iTunes , Android , or Stitcher Article Safety and tolerability of i.v. There were no infusion-related reactions including phlebitis or IV site reactions that were documented. Episode 812: Can You IV Push Piperacillin/Tazobactam?

Inpatient 105

Inpatient Documentation 105

Pharmacy Joe

OCTOBER 25, 2023

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

Dosage 111

Dosage Inpatient Packaging Documentation 111

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 96

Adverse Reactions Documentation Medical Schools Packaging 96

European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

Documentation 52

Documentation Packaging Pharmaceutical Manufacturing 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 98

Documentation 98

Drug Patent Watch

JANUARY 15, 2025

This article explores the limitations of Google Patents in this context and suggests alternative approaches. Understanding Google Patents Google Patents is a search engine that allows users to search the full text of patent documents from around the world.

Documentation 52

Documentation 52

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 98

Documentation 98

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 105

Documentation 105

Pharmacy Joe

OCTOBER 2, 2024

A recent review article published in AJHP detailed the role of toxin inhibition to treat C. Clindamycin is given a strong recommendation by the IDSA to be added to penicillin for treatment of documented group A streptococcal necrotizing fasciitis. diff, Staph aureus, and Strep infections.

Inpatient 97

Inpatient Documentation 97

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.

Omnicell 98

Omnicell Pharmaceutical Companies Pharmaceutical Companies Documentation 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. 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 98

Documentation 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.

Documentation 104

Documentation 104

GMPSOP

JULY 14, 2024

This article provides an in-depth look at how you, as a professional in a GMP business, can prepare quality planning documentation, especially from the perspective of a medical device manufacturing business. Additional documents included each month. Documentation control b. Additional documents included each month.

Documentation 59

Documentation Customer Service Health and Personal Care Stores Communication 59

Pharma Marketing Network

MAY 9, 2025

This article uncovers the hidden elements of market access success, revealing what it takes to move from FDA approval to formulary inclusion, provider buy-in, and patient adoption. A value document submitted to payers outlining clinical data, economic models, and patient impact to support formulary inclusion. What is an AMCP dossier?

Packaging 52

Packaging Documentation Communication 52

ID Stewardship

OCTOBER 14, 2024

In this article a pharmacist with experience in writing and publishing provides 5 quick tips for pharmacy residents preparing manuscripts Authored By: Timothy P. BCPS, BCIDP Article Posted October 2024, First Released in the June 2024 IDstewardship Newsletter Tip 1: Start by picking an article type and journal The article type (e.g.,

Documentation 52

Documentation Communication 52

GMPSOP

AUGUST 8, 2023

Transferring Analytical Test Methods in GLP Laboratories Pharmaceuticals quality assurance & validation procedures GMPSOP Transferring Analytical Test Methods in GLP Laboratories The purpose of this article is to establish a documented process for the transfer of analytical methodology. Additional documents included each month.

Documentation 40

Documentation 40

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. It’s like a bridge connecting the intricate world of medical science to everyday healthcare communication.

Communication 52

Communication Documentation Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

APRIL 6, 2021

It started as a hobby, just a way of documenting my life as a young man with a disability that I could look back on in years to come,” he says. “It Recent articles, for example, have included a look at trolls online and covered Ross’ lockdown diaries. It grew and grew and it is now a real passion of mine.

Documentation 132

Documentation 132

GMPSOP

MAY 31, 2024

This article can help you understand who is responsible for preparing the validation master plan, the stages of the validation life cycle, the risk-based prioritization of validation items, how to prepare a validation schedule, and some practical examples. – General guidance for validation document format. 12 or 24 months). .

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

Proxsys Rx

APRIL 1, 2025

In a nutshell, says ProxsysRx 340B Optimization Manager Chance Spivey, the CE would have to pay retail prices first to allow for replenishment and THEN submit documentation like they do for 340B ESP (this time with even more claims info). Automate your 340B program with customized software streamlining documentation and reporting.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Documentation Drug Pricing 52

Pharma in Brief

APRIL 26, 2021

The FCA also continues to encourage Parties to file their non-confidential documents by email, [2] and to refer to the e-filing guide, Requirements and Recommendations For Filing Electronic Court Documents in the Federal Court of Appeal. Guerreiro and David Yi for their help in drafting this article. [1]

Documentation 52

Documentation 52

Drug Channels

OCTOBER 3, 2024

The article below highlights an underappreciated consequence of the Inflation Reduction Act’s inflation rebates for Medicare Part B drugs. As we document below, a growing share of Part B drugs have inflation-adjusted coinsurance rates that have been increasing , not declining. Click here to see our original post from May 2024.

Documentation 52

Documentation 52

GMPSOP

AUGUST 11, 2024

To maintain the integrity and safety of these investigational products, you must adhere to Good Manufacturing Practice (GMP), FDA Clinical Trail Guidance Documents , and relevant ISO or EN standards. Additional documents included each month. Additional documents included each month. ensure traceability and compliance.

Packaging 52

Packaging Documentation Labelling Dosage 52

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 98

Packaging Documentation Communication Pharmaceutical Companies 98