ISPE

AUGUST 30, 2023

Contamination Control Strategy: With the implementation of the revised Annex 1 slated for 25 August, 2023, concerns around compliance surrounding Annex 1 are growing and will be at the forefront of the 2023 ISPE Annual Meeting & Expo. At the core of the updated Annex 1 is the heightened focus on the CCS.

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Documentation Vaccines 98

The Guardian - Pharmaceutical Industry

OCTOBER 19, 2024

According to internal documents obtained by the Observer , Novo Nordisk wanted “data from the Department for Work and Pensions” to “ help profile those who are most likely to return to the labour market”. Shifting blame to the victims of economic policy is an old trick by politicians.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 110

OctariusRx

FEBRUARY 20, 2023

The 2023 controlled substance assessment quiz is about to be released! If you read my post in December about How Much Does Compliance Cost , you know that not following proper processes and poor documentation can lead to patient harm and/or large fines from regulatory agencies such as the United States Drug Enforcement Administration (DEA).

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Controlled Substances Documentation Compounding 79

Fuld

NOVEMBER 13, 2023

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

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Documentation 52

OctariusRx

MAY 15, 2023

Our 2023 nursing calculations quiz is now available. Since medications are usually dosed milligrams per kilogram, learn to consistently convert and document the patient’s weight in kilograms. If you’re already part of our team, you can expect to see the 2023 Nursing Medication Calculations Quiz during our upcoming facility visit.

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Long-Term Care Facilities Labelling Medication Labelling Documentation 74

Digital Pharmacist

NOVEMBER 21, 2022

However, in 2023, health plans should improve member engagement by scheduling a visit for preventative care or completing a missed screening. b) Patient Experience Rating: When determining Star Ratings starting in 2023, patient experience ratings will be quadruple weighted. Road Towards Approval.

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Communication Documentation Immunization Vaccines 98

PhRMA

JANUARY 25, 2023

Earlier this month, the American Cancer Society (ACS) released its annual report, Cancer Statistics 2023, finding the overall cancer mortality rate has declined 33% since peaking in 1991, leading to an estimated 3.8 This report is the latest to document this progress. million averted cancer deaths over this period.

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Documentation 254

ISPE

MARCH 3, 2023

ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track! Trudy Patterson Fri, 03/03/2023 - 13:15 iSpeak Blog iSpeak ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track! 2023 ISPE Biotechnology Conference Frank Henrichmann Heather D.

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Documentation FDA 98

European Pharmaceutical Review

SEPTEMBER 12, 2023

As part of The Future of Pharma/Biopharma Analysis 2023 , which took place on 28-29 June 2023, European Pharmaceutical Review ( EPR ) gathered an expert panel to discuss developing a modern contamination control strategy. Early adopters started putting these strategies together around 20 years ago.

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Documentation 128

pharmaphorum

JANUARY 9, 2023

This Nine for 2023 three-part series will argue that, this year, the future-facing Janus prediction of unprecedented and transformative change is true. However, the pandemic is only one of the often deep-rooted forces that will come together in 2023 to exert transformative pressure on healthcare.

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Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 96

European Pharmaceutical Review

AUGUST 25, 2023

As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. What is included in the new revision?

Documentation 98

Documentation 98

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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FDA Documentation Method Validation Packaging 98

European Pharmaceutical Review

JULY 4, 2023

The International Organization for Standardization (ISO) has published its new standard Sterilization of health care products — Microbiological methods — Part 3 Bacterial endotoxin testing ( ISO 11737-3:2023). The document contains requirements and guidance for testing for bacterial endotoxins.

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Documentation Labelling 111

The FDA Law Blog

JULY 6, 2023

We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here ). This would align with the timeline in the Unified Agenda which identifies December 2023 as the expected publication date for the final rule.

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FDA Documentation Labelling 52

STAT

NOVEMBER 14, 2023

Internal documents show that a UnitedHealth subsidiary called NaviHealth set a target for 2023 to keep rehab stays of patients in Medicare Advantage plans within 1% of the days projected by the algorithm.

Health Insurance Companies 145

Health Insurance Companies Insurance Documentation 145

STAT

MAY 20, 2024

A huge amount of those documents were released last week, and the numbers mirror what  we’ve been seeing over the past several months : Not all hospitals are in dire straits, and in fact, many continue to do quite well. Sign up to get it in your inbox every Monday. Continue to STAT+ to read the full story…

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Hospitals Documentation 106

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’. Implementation of the ICH M10 document The EU date of coming into effect of the core ICH M10 document and the corresponding Q&As was 21 January 2023.

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Method Validation Documentation FDA 98

ISPE

SEPTEMBER 8, 2023

2023 ISPE Aseptic Conference Regulatory Panel Logan Thomas Fri, 09/08/2023 - 11:35 InTouch September / October 2023 2023 ISPE Aseptic Conference Regulatory Panel Jörg Zimmermann 1 September 2023 On 7 March 2023, ISPE concluded the 2023 ISPE Aseptic Conference with a regulatory panel question and answer session.

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FDA Vaccines Documentation 52

PQA

FEBRUARY 23, 2023

In 2023, PQA’s COPD Treatment Ratio (CTR) TEP will conclude following its launch in 2022. PQA will launch two additional TEPs in 2023. Self-nominations for these TEPs will be communicated to PQA members in the second or third quarter of 2023, and we encourage interested PQA members to submit a self-nomination for consideration.

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Specialty Pharmacies Documentation Communication 40

The FDA Law Blog

MARCH 27, 2023

The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA. So, what is special about September 24, 2023? For the stakeholders who use UPC as their device identifier, UDI alternatives UDI-A160001 and UDI-A16002 will expire on September 24, 2023.

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Packaging Labelling FDA Documentation 44

European Pharmaceutical Review

MARCH 13, 2024

The data integrity violations API deviations in the microbiology lab The first deviation – failure to follow and document laboratory controls at the time of performance, and failure to document and explain any departures from laboratory procedures – relates to the lack of data integrity within the microbiology laboratory.

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FDA Documentation 98

Pharmaceutical Technology

APRIL 13, 2023

Projections for 2023 Digitalisation is key moving forward Fully utilising digitalisation as part of a DCT can result in savings in both time and costs. In the US, the FDA (Food and Drug Administration) granted accelerated approvals of medical devices with AI in 2022 [8] , and growing use is expected throughout 2023.

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Documentation Communication FDA 52

STAT

OCTOBER 20, 2023

The agency’s data indicate that, after a lull during the Covid-19 pandemic, the number of authorized devices in 2023 is expected to increase by more than 30% over the prior year.

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FDA Documentation 121

Pharmaceutical Technology

MAY 17, 2023

No, you can upload your case studies as a Word or PDF document using the upload feature in the online form or email it How will our case studies be used? Case study information may be published alongside your award.

Packaging 52

Packaging Documentation 52

European Pharmaceutical Review

NOVEMBER 14, 2023

On 1 October 2023, the final, official version of the chapter was published. Glass container manufacturing This change follows the USP’s Compendial Notice from January 2023, in which the PD EC announced that it intended to revise the General Chapter.

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Packaging Vaccines Documentation FDA 105

ISPE

MAY 1, 2023

It often took me multiple weeks of Computer Based Training (CBT) and reading documents. I created the templates in my own time and first only used them for my own information, as a reference book, instead of using the regulations to review compliance of CSV documents and controls. Several times I even didn’t pass the exams.

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Documentation 98

European Pharmaceutical Review

JULY 5, 2023

Revised for 2023, the Parenteral Drug Association (PDA) has published an update to its Technical Report No. Having been originally published in 2007, then revised in 2013, this latest 2023 edition addresses evolving standards and container types.

Packaging 96

Packaging Documentation Pharmaceutical Companies Pharmaceutical Companies 96

The FDA Law Blog

AUGUST 7, 2023

Submit proposal documents by email to ELP Proposal Submissions by September 5, 2023 at 12 PM ET. Identify the site visit duration. Most common are one- or two-day site visits.) Indicate ability to host a virtual site visit.

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Documentation Insurance FDA 40

European Pharmaceutical Review

JULY 18, 2023

In 2023, the deviation management sector is expected to account for the largest share of the pharmaceutical quality management market. Yet the productivity of their R&D investment, compared to the number of drugs introduced to the market each year, is decreasing. Also noted in the report was the shift towards cloud-based systems.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 98

The FDA Law Blog

OCTOBER 18, 2022

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023.

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Documentation FDA Labelling 52

ISPE

FEBRUARY 14, 2023

ISPE’s Regulatory Commenting Process Trudy Patterson Tue, 02/14/2023 - 16:19 iSpeak Blog iSpeak ISPE’s Regulatory Commenting Process Wendy McGhee 14 February 2023 What is Commenting? After a thorough internal review, health authorities sometime release a document for public comment. Give specific examples to illustrate concerns.

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Documentation Communication 52

Pharmafile

JANUARY 5, 2023

It is possible that Island Pharmaceuticals could begin its phase 2a PEACH clinical trial as soon as January 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. The trial aims to assess its dengue prevention and treatment drug, ISLA-101. read more.

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Documentation FDA 52

The FDA Law Blog

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. In contrast , the two previous withdrawals, Makena in 2023 and Avastin in 2011, took 30 months and 11 months, respectively. On August 4, 2023, Oncopeptides submitted its appeal.

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FDA Documentation Labelling 57

ISPE

APRIL 12, 2023

A Closer Look at Paperless Validation’s Impact on Biotech Trudy Patterson Wed, 04/12/2023 - 07:34 iSpeak Blog iSpeak A Closer Look at Paperless Validation’s Impact on Biotech Steven Thompson 12 April 2023 The impact of paperless validation on the biotechnology industry is massive, and the overall effect is growing as adoption increases.

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Documentation FDA 98

ISPE

MARCH 23, 2023

A True Copy is an exact copy of original documentation that preserves the same content, meaning and attributes of the original. It is an electronic copy maintained in an electronic document management system. This negates the requirement for storage of paper evidence and correct GMP document management of these hardcopy evidences.

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Documentation FDA 98

Hospital Pharmacy Europe

AUGUST 17, 2023

11 Many documents and checklists detail every stage of the pathway in preparing CAR T. 12 The document aims to harmonise the implementation of hospital pharmacy CAR T services. 12 The document aims to harmonise the implementation of hospital pharmacy CAR T services. In: UpToDate, Lowenberg, Rosmarin, UpToDate, Waltham, MA, 2023.

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Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

The FDA Law Blog

OCTOBER 16, 2023

In particular, the article discusses FDA’s April 2023 draft guidance on pre-determined change control plans (which we previously blogged on here ) and whether such plans afford sufficient flexibility for AI/ML developers to innovate and improve products based on new data while also providing sufficient guardrails to ensure patient safety.

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Documentation FDA 117