Proposed Changes of USP Strengthens Documentation Requirements
Pharmacy Times
JULY 25, 2022
Once the revisions to become approved, there will be a minimum grace period of 6 months for pharmacies to comply.
Pharmacy Times
JULY 25, 2022
Once the revisions to become approved, there will be a minimum grace period of 6 months for pharmacies to comply.
Pharmafile
JANUARY 20, 2023
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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Pharma Phorum
NOVEMBER 13, 2020
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.
Fierce Healthcare
SEPTEMBER 15, 2021
Industry Voices—Not all automation is created equally for clinical documentation improvement. hlandi. Wed, 09/15/2021 - 15:26
Fierce Healthcare
SEPTEMBER 7, 2022
Healthcare AI company Iodine Software teams with TruCode to improve hospitals' clinical documentation. hlandi. Wed, 09/07/2022 - 06:56
Outsourcing Pharma
JANUARY 28, 2022
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.
Pharmaceutical Commerce
JULY 19, 2022
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Pharmacy Times
NOVEMBER 17, 2022
Importance of clear and accurate documentation is emphasized in patient claim for compensation.
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.
Pharmacy Times
JUNE 24, 2022
The impact of the pandemic on the mental health of health care workers, including pharmacists and pharmacy staff, has been well documented.
IDStewardship
SEPTEMBER 2, 2022
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.
Outsourcing Pharma
APRIL 14, 2022
The US agencyâs latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.
Pharmacy Times
JUNE 28, 2022
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.
IDStewardship
AUGUST 17, 2022
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.
European Pharmaceutical Review
JANUARY 26, 2023
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.
Pharmafile
JANUARY 5, 2023
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.
Outsourcing Pharma
NOVEMBER 1, 2022
The Association of Clinical Research Organizations (ACRO) has released a question and answer document to support the adoption of decentralized clinical trials (DCT).
Fossil Remedies
APRIL 26, 2022
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.
Pharma Times
MARCH 3, 2022
NICE document recommends Amgen’s Lumykras (sotorasib) to treat non-small-cell lung cancer
Fossil Remedies
OCTOBER 16, 2022
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.
Pharmacy Times
SEPTEMBER 1, 2022
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.
Outsourcing Pharma
DECEMBER 1, 2021
A leader from the pharmacovigilance solutions firm discusses the ins and outs managing safety documentation and offers advice on how to deal with them.
InCrowd
JUNE 9, 2022
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.
Outsourcing Pharma
SEPTEMBER 27, 2022
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.
Elsevier
APRIL 26, 2022
First, they are very long documents – they can be around 800 pages long.
Outsourcing Pharma
JUNE 17, 2021
The US federal agency has released a document designed to help clinical trial teams obtain effective, efficient data from patients in their cancer research.
Pharma Times
MARCH 4, 2021
Final appraisal document said that clinical trial evidence for Poteligeo is ‘very uncertain’
Pharma Phorum
SEPTEMBER 30, 2022
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.
Fossil Remedies
NOVEMBER 26, 2021
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.
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.
Fossil Remedies
SEPTEMBER 23, 2022
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.
European Pharmaceutical Review
AUGUST 23, 2022
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.
Elsevier
JUNE 1, 2022
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.
IDStewardship
AUGUST 29, 2022
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.
NF2 BioSolutions
MARCH 16, 2022
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.
Pharma Mirror
NOVEMBER 21, 2020
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.
Pharma Phorum
JANUARY 26, 2023
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.
Elsevier
APRIL 5, 2022
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.
European Pharmaceutical Review
DECEMBER 21, 2022
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.
Pharmacy Friday Pearls
AUGUST 29, 2022
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.
European Pharmaceutical Review
JANUARY 17, 2023
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 ’.
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.”
Pharma Phorum
JANUARY 20, 2022
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.
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