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Proposed Changes of USP Strengthens Documentation Requirements

Pharmacy Times

Once the revisions to become approved, there will be a minimum grace period of 6 months for pharmacies to comply.

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Intas Pharmaceuticals under FDA scrutiny after oversight in GMP documents

Pharmafile

India-based manufacturer Intas Pharmaceuticals has been issued a Form 483 by the FDA after three investigators found a “cascade of failure” in a site inspection carried out at their manufacturing facility in Pharmez Special Economic Zone (SEZ) between late November and early December 2022.

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Clinical Document World | Virtual 2021

Pharma Phorum

Join us at our 2nd Clinical Document World Virtual event on January 19-21, 2021, alongside your TMF, clinical quality, document management, and clinical professionals to explore a strategic clinical process and ensure a complete Document Management Process.

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Industry Voices—Not all automation is created equally for clinical documentation improvement

Fierce Healthcare

Industry Voices—Not all automation is created equally for clinical documentation improvement. hlandi. Wed, 09/15/2021 - 15:26

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Healthcare AI company Iodine Software teams with TruCode to improve hospitals' clinical documentation

Fierce Healthcare

Healthcare AI company Iodine Software teams with TruCode to improve hospitals' clinical documentation. hlandi. Wed, 09/07/2022 - 06:56

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New FDA draft guidance document gets real about RWD use

Outsourcing Pharma

A representative from IQVIA discusses the particulars of the US agencyâs new draft document and shares what it might mean for clinical trial data evaluation.

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Egnyte Announces Document Certification Service Using Blockchain Technology

Pharmaceutical Commerce

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Immunization Injection Injury Occurs at Pharmacy

Pharmacy Times

Importance of clear and accurate documentation is emphasized in patient claim for compensation.

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5 Important Things To Know About Social Media As A Resource For Pharmacy Residency Recruitment – For Both Candidates And Programs 

IDStewardship

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.

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Pandemic Created Combat Like Trauma for Pharmacists

Pharmacy Times

The impact of the pandemic on the mental health of health care workers, including pharmacists and pharmacy staff, has been well documented.

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Why Is Nobody Using Your Guidelines? – Insights On Designing Useful Guidelines For Infectious Diseases

IDStewardship

CMS also mentions guidelines several times in their 22-page document on new antimicrobial stewardship requirements for hospitals. We need to stop thinking of guidelines as flat, text documents resembling journal articles.

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FDA draft guidance outlines path to increased trial inclusivity

Outsourcing Pharma

The US agencyâs latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.

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Vyepti Shows Positive Results in the Treatment of Migraine

Pharmacy Times

Investigators studied the efficacy and safety of eptinezumab-jjmr in the 100 mg and 300 mg intravenous infusion dosages in individuals with 2 to 4 documented unsuccessful prior preventive treatment failures for migraine in the past 10 years.

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Top 5 Tips On How To Run Successful Meetings As A Pharmacist

IDStewardship

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

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EMA publishes updated Q&A for ICH M10

European Pharmaceutical Review

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. Therefore, the additional Q&A document is intended to provide further clarification.

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Island Pharmaceuticals to begin phase 2 trial for dengue prevention and treatment drug

Pharmafile

The submission of this document is expected shortly, at which point the FDA will begin an ‘up to’ 30-day review of the application. It is possible that Island Pharmaceuticals could begin its phase 2a PEACH clinical trial as soon as January 2023.

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ACRO answers decentralized trial questions to ease worries and increase uptake

Outsourcing Pharma

The Association of Clinical Research Organizations (ACRO) has released a question and answer document to support the adoption of decentralized clinical trials (DCT).

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How To Prepare A Successful PCD Pharma Business Plan?

Fossil Remedies

Gather all documents. Documentation is an important, essential, and unavoidable step. When a PCD pharma business is launched, you need some documents mandatorily. The Drug License Number and GST Number are these two documents. PCD Pharma Business Plan.

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Previously untreatable lung cancer patients offered new therapy

Pharma Times

NICE document recommends Amgen’s Lumykras (sotorasib) to treat non-small-cell lung cancer

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Is License Compulsory For Starting Pharmaceutical Business In India?

Fossil Remedies

But apart from that, you need to put the effort into completing the documentation also. These are mandatory documents required to launch a business. The document and license application process is the same in the majority of the field.

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Effective Treatment for Some Patients with Arndt-Gottron Syndrome Can Be Achieved With IVIG

Pharmacy Times

Though there is no well-defined therapeutic approach to the treatment of Arndt-Gottron syndrome, intravenous immunoglobulins have been documented as a well-tolerated treatment in some cases.

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Automating safety processes can benefit DCTs: Pharmasol

Outsourcing Pharma

A leader from the pharmacovigilance solutions firm discusses the ins and outs managing safety documentation and offers advice on how to deal with them.

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Primary Care

InCrowd

It is the PCP who must spend the most time feeding the maw of the electronic medical record (EMR) with meaningless clicks to document items that have minimal benefit to the patient.

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Q&A: AI’s place in leveraging compliance data for clinical trials

Outsourcing Pharma

Compliance data generated from the documentation of interactions with HCPs can be leveraged using AI and ML to the benefit of stakeholders across the industry, according to IQVIA.

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Pharma can now track the most relevant patent info – fast and at scale

Elsevier

First, they are very long documents – they can be around 800 pages long.

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FDA issues guidance for measuring PROs in oncology studies

Outsourcing Pharma

The US federal agency has released a document designed to help clinical trial teams obtain effective, efficient data from patients in their cancer research.

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NICE rejects rare blood cancer treatment Poteligeo in final appraisal

Pharma Times

Final appraisal document said that clinical trial evidence for Poteligeo is ‘very uncertain’

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Moving to component management & traceability: progress, barriers, and the way forward

Pharma Phorum

Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Building documents from components also reduces review cycle time frames.

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What Is PCD Pharma Franchise Monopoly Basis?

Fossil Remedies

If both are available, then you have to go ahead with the documentation and other processes. Monopoly PCD Pharma franchise model is a specialized business model where the company provides franchises on a monopoly basis all over the country for marketing and distribution of products.

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How should cleaning validation sampling locations be chosen?

European Pharmaceutical Review

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.

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How To Choose Low Price Good Quality PCD Franchise?

Fossil Remedies

Check all documents and certificates. PCD Pharma Franchise is a popular business model. What is that? PCD is an abbreviation of the word Propaganda Cum Appropriation.

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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

Of the cGMP letters, three major types of violations – deficiencies in process validation, documentation practices (data integrity) and quality control – accounted for 26 percent, 21 percent and 15 percent of warning letters respectively.

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How pharma can make drug information accessible

Elsevier

Also, the longer that a drug is on the market, the more its manufacturer might learn and document about its effects. Pharmaceutical drugs can work wonders for patients, whether it’s treating rare diseases or easing everyday maladies. But drugs can also be complex.

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Tips For New Pharmacists – From An Antimicrobial Stewardship Pharmacist

IDStewardship

Learning from my experience, it would save you a lot of time in the future to note down the key points from your research on a running document and file them in a place that you can easily find and refer to in the future.

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Amy Versus Life Blog (Amy Taplin)

NF2 BioSolutions

I’ve been documenting my brain tumour surgery (2/9/21) and recovery over on instagram. Hi I’m Amy. My NF journey begun at 10, well that’s when we found the first tumour.

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FIP expert group issues advice for pharmacists on COVID-19 tests

Pharma Mirror

The Hague — To help pharmacists advise people on COVID-19 tests, the International Pharmaceutical Federation (FIP), has today issued a guidance document. The document covers how different types of diagnostic test work and the interpretation of results.

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ABPI code updated with first social media guidance

Pharma Phorum

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time.

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Elsevier research partner Karin Verspoor nominated For Women in AI award

Elsevier

The AI technologies we are developing facilitate rapid ingestion and processing of these documents and make the valuable information contained within them structured and searchable,” says Karin. Network.

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Whole genome sequencing and analysis of live biotherapeutic products

European Pharmaceutical Review

Therefore, characterisation of the microorganism(s) is of utmost importance to LBP quality documentation. The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines.

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High-Dose Insulin Euglycemic Therapy in Calcium Channel Blocker and Beta-Blocker Toxicity

Pharmacy Friday Pearls

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. Author: Nicole Frost, PharmD. Download PDF. Introduction.

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UK ATMP clinical trials report 2022 published

European Pharmaceutical Review

The document was commissioned by the Advanced Therapy Treatment Centres network’s Industry Advisory Group. The Cell and Gene Therapy (CGT) Catapult has published its ‘ UK Advanced Therapy Medicinal Products (ATMP) Clinical Trials Report 2022 ’.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

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.”

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Gilead takes legal action against counterfeit HIV drug network 

Pharma Phorum

According to the company, the defendants reportedly sold 85,247 bottles of medicine with counterfeit Gilead labelling to pharmacies over a two-year period, using falsified supply chain documentation to conceal their origin.