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.

Documentation 103

Documentation 103

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.

Documentation 52

Documentation FDA 52

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.

Documentation 52

Documentation 52

Fierce Healthcare

SEPTEMBER 15, 2021

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

Documentation 102

Documentation 102

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

Documentation 68

Documentation Hospitals 68

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.

Documentation 63

Documentation FDA 63

Pharmaceutical Commerce

JULY 19, 2022

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Documentation 40

Documentation 40

Pharmacy Times

NOVEMBER 17, 2022

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

Immunization 109

Immunization Documentation 109

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.

Documentation 207

Documentation 207

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.

Documentation 143

Documentation 143

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.

Formulary Information 130

Formulary Information Documentation Hospitals Medication Guidelines 130

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.

Documentation 83

Documentation FDA 83

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.

Dosage 103

Dosage Documentation 103

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.

Documentation 130

Documentation 130

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.

Method Validation 59

Method Validation Documentation FDA 59

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.

Documentation 52

Documentation FDA 52

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).

Documentation 52

Documentation 52

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.

Documentation 56

Documentation 56

Pharma Times

MARCH 3, 2022

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

Documentation 39

Documentation 39

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.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

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.

Documentation 65

Documentation 65

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.

Documentation 56

Documentation 56

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.

Medical Schools 83

Medical Schools Documentation Medical Records 83

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.

Documentation 52

Documentation 52

Elsevier

APRIL 26, 2022

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

Documentation 82

Documentation Pharmaceutical Companies Pharmaceutical Companies Compounding 82

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.

Documentation 52

Documentation FDA 52

Pharma Times

MARCH 4, 2021

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

Documentation 31

Documentation 31

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.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 52

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.

Documentation 76

Documentation 76

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 82

Documentation 82

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.

Documentation 52

Documentation 52

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.

Documentation 75

Documentation Packaging Labelling FDA 75

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.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies Communication 52

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.

Hospitals 130

Hospitals Dosage Documentation Compounding 130

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.

Documentation 52

Documentation 52

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.

Documentation 52

Documentation Immunization 52

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.

Documentation 83

Documentation Communication 83

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.

Compounding 52

Compounding Documentation Pharmaceutical Companies Pharmaceutical Companies 52

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.

Documentation 81

Documentation FDA 81

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.

Packaging 52

Packaging Documentation 52

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 ’.

Documentation 72

Documentation 72

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 70

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 70

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.

Documentation 91

Documentation Labelling FDA 91