Pharmaceutical Technology

JULY 19, 2022

Mentions of cloud computing within the filings of companies in the pharmaceutical industry rose 65% between the final quarter of 2021 and the first quarter of 2022. Of the 10 biggest employers in the pharmaceutical industry, IQVIA was the company which referred to cloud computing the most between April 2021 and March 2022.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 98

STAT

FEBRUARY 27, 2024

antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022. A much-anticipated inquiry by U.S.

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Documentation Insurance 145

European Pharmaceutical Review

FEBRUARY 29, 2024

She emphasised this recommendation is significant because DVCd “has been available in Scotland and Northern Ireland since 2022”. NICE’s positive decision, which is detailed in the final appraisal document , follows an appeal against NICE’s original guidance from November 2022.

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Documentation Pharmaceutical Companies Pharmaceutical Companies 100

ISPE

NOVEMBER 2, 2022

2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives. Wed, 11/02/2022 - 10:20. 2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives. 2 November 2022. Zimmermann outlined the two main projects of the Board during 2022. Expenses for documents and conferences have been higher this year.

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Documentation Compounding Communication FDA 52

PharmaShots

JUNE 14, 2023

In the year 2022, Roche ranked the top among the Diagnostic Companies with a total revenue of $19.17B followed by GE Healthcare and Siemens Healthineers with $17.72B and $17.64B PharmaShots brings an informative report on the Top 20 Diagnostic Companies Based on the Total Revenue generated in the year 2022 Diagnostic Revenue: $674.7M

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FDA Hospitals Documentation Patient Care 56

ISPE

NOVEMBER 23, 2022

Regulatory Insights from 2022 ISPE Annual Meeting. Wed, 11/23/2022 - 12:32. Regulatory Insights from 2022 ISPE Annual Meeting. 23 November 2022. He closed with a comparison between Canada’s Certified Product Information Document (CPID) and ICH’s Product Lifecycle Management (PLCM) documents. Trudy Patterson.

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FDA Documentation 52

Pharmaceutical Technology

JULY 12, 2022

Mentions of digitalization within the filings of companies in the pharmaceutical industry fell 38% between the first and second quarters of 2022. Of the 10 biggest employers in the pharmaceutical industry, Novartis was the company which referred to digitalization the most between July 2021 and June 2022. of all sentences.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

JUNE 28, 2022

Mentions of robotics within the filings of companies in the pharmaceutical industry fell 22% between the final quarter of 2021 and the first quarter of 2022. Of the 10 biggest employers in the pharmaceutical industry, J&J was the company which referred to robotics the most between April 2021 and March 2022. of all sentences.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 52

Pharmaceutical Technology

AUGUST 9, 2022

Mentions of artificial intelligence within the filings of companies in the pharmaceutical industry fell 24% between the first and second quarters of 2022. Of the 10 biggest employers in the pharmaceutical industry, Novartis was the company which referred to artificial intelligence the most between July 2021 and June 2022.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

ISPE

NOVEMBER 3, 2022

2022 ISPE Annual Meeting: Convergence and Harmonization Support New Therapies. Thu, 11/03/2022 - 13:48. 2022 ISPE Annual Meeting: Convergence and Harmonization Support New Therapies. 3 November 2022. 2022 ISPE Annual Meeting & Expo. Trudy Patterson. iSpeak Blog. Susan Sandler.

Communication 98

Communication FDA Documentation Vaccines 98

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 88

pharmaphorum

JANUARY 18, 2022

Main Conference: April 25 – 26, 2022 | Workshops: April 27, 2022. Chair for 2022: Gretchen Vandal, Sr. Featured 2022 Speakers Include: Joyce Zhao, Associate Director, Combination Product, Takeda. Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion.

Packaging 52

Packaging FDA Documentation Vaccines 52

STAT

OCTOBER 20, 2023

The update included 171 new products that use artificial intelligence and machine learning, including 155 authorized since August of 2022. 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 130

ISPE

OCTOBER 28, 2022

International Collaboration and Reliance: Regulatory Panel Discussion at the 2022 ISPE Singapore Conference. Fri, 10/28/2022 - 13:06. International Collaboration and Reliance: Regulatory Panel Discussion at the 2022 ISPE Singapore Conference. 28 October 2022. 2022 PIC/S Chair, Sr. Trudy Patterson. iSpeak Blog.

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FDA Vaccines Dosage Documentation 97

European Pharmaceutical Review

SEPTEMBER 12, 2023

Although core to the new EU GMP Annex 1 1 – mentioned more than 50 times in the 2022 version of the document – contamination control strategies are not new. Early adopters started putting these strategies together around 20 years ago.

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Documentation 124

STAT

JANUARY 21, 2023

(AP) — Elizabeth Holmes is a flight risk and shouldn’t be allowed to stay out of prison while she appeals her 11-year prison sentence for defrauding investors, federal prosecutors said in court documents. Holmes had a one-way plane ticket to Mexico booked for Jan.

Documentation 98

Documentation 98

ISPE

NOVEMBER 1, 2022

2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. Tue, 11/01/2022 - 06:49. 2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. 1 November 2022. 2022 ISPE Annual Meeting & Expo. Trudy Patterson. iSpeak Blog. Susan Sandler.

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FDA Insurance Chemotherapy Documentation 98

STAT

FEBRUARY 28, 2024

antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022 , STAT writes. The … A much-anticipated inquiry by U.S.

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FDA Documentation Insurance 129

Board Vitals - Pharmacist

MARCH 16, 2022

According to the Association of American Medical Colleges , the average cost of medical school including tuition, fees, and health insurance for first-year students attending in-state public schools in 2021-2022 was $39,237, a 29% increase from the cost in 2012-13 ($30,192). Applications are accepted until May 1 st , 2022. .

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Medical Schools Documentation Insurance 52

ISPE

SEPTEMBER 14, 2022

Wed, 09/14/2022 - 11:15. 14 September 2022. It’s focusing on what matters, which has to be quality instead of compliance and documentation. What about capturing the requirements into a word document versus using a requirements management tool? Documentation alone is no defence against defects. Trudy Patterson.

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Documentation Communication 97

Pharmaceutical Technology

MAY 18, 2023

Within the 14-page document , published by an EMA special task force, are 10 recommendations of best practices that “marketing authorisation holders, wholesalers, distributors, and manufacturers can consider adopting to ensure continuity of medicinal product supply and reduce the impact of shortages”.

Communication 99

Communication Documentation Patient Care 99

The FDA Law Blog

AUGUST 16, 2023

Mr. Godwin’s presentation made the same point, although with more data to back it up: so far this fiscal year (since October 1, 2022), the number of OAI inspections resulting in the exercise of regulatory discretion is unusually high.

Documentation 97

Documentation FDA 97

Med Ed 101

JUNE 9, 2021

The post Preparing For The BCMTMS Exam in 2021-2022 appeared first on Med Ed 101. I’m happy with the testimonials that we have received that make me believe we provide the best resources on the market that […].

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Documentation 40

ISPE

APRIL 12, 2023

Paper-Based Validation in Biotech: No Longer a Choice The complexities of biological processes like cell line development, protein expression, and capsid engineering demand extreme precision and thorough documentation for regulatory bodies. Compliance — Regulators want to see consistent, GDocP-compliant, template-based documentation.

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Documentation FDA 98

IDStewardship

OCTOBER 28, 2022

Article Posted 28 October 2022. The results of the 2022 match developed a few questions: How will programs react to the declining number of graduating pharmacists and enrollment of pharmacy students ? Develop a manual or guidance document outlining the goals of the account. Authored by: Hunter O. Rondeau, Pharm.D. UKPharmRes.

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Documentation 229

STAT

NOVEMBER 17, 2023

 The company’s final study plan was submitted to the FDA in 2022 and is expected to be completed  by 2030 , according to FDA briefing documents published earlier this week. They were approved under the FDA accelerated pathway in 2009 and 2014, respectively, for treating a rare form of blood cancer. The

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FDA Documentation 108

European Pharmaceutical Review

JANUARY 13, 2023

Commission (EPC) adopted the revised general monographs 2034 and 2619 , at its 174th session in November 2022 , which now includes a paragraph explaining the Ph. European Pharmacopoeia Commission’s November 2022 session highlights: Approval of the Ph. Priorities for 2022-2025. The European Pharmacopoeia (Ph. and non-Ph.

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Documentation Vaccines 94

The FDA Law Blog

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted.

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Documentation FDA 52

ISPE

NOVEMBER 23, 2022

Wed, 11/23/2022 - 06:50. 23 November 2022. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 50th anniversary at a special symposium in Dublin, Ireland on 4 October 2022. ISPE Represented at PIC/S 50th Anniversary Event. Trudy Patterson. iSpeak Blog. ISPE Represented at PIC/S 50th Anniversary Event.

Documentation 98

Documentation FDA Communication 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. Cham (CH): Springer; 2022: Chapter 43. GoCART Coalition.

Hospitals 98

Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

pharmaphorum

JULY 14, 2022

Instant messages should be recognised as EU documents under transparency rules, and recorded and made available for freedom of information requests. — European Ombudsman (@EUombudsman) July 14, 2022. Full list: [link].

Documentation 52

Documentation Vaccines 52

ISPE

SEPTEMBER 15, 2022

Thu, 09/15/2022 - 13:50. 15 September 2022. During the 2022 ISPE Pharma 4.0™ Annex 1 Implementation Strategies. Trudy Patterson. iSpeak Blog. Annex 1 Implementation Strategies. Thomas Zimmer, PhD. Annex 1 of the EC GMP Guide " Manufacture of Sterile Medicinal Products " has a long history.

Documentation 97

Documentation FDA 97

European Pharmaceutical Review

AUGUST 5, 2022

Clinigen Healthcare is recalling three batches of Mexiletine hydrochloride hard capsules, indicated for the treatment of documented arrhythmias, due to a potential risk of under- or overdose, which could have consequences for the safety of patients. 10/02/2022. 10/02/2022. 10/02/2022. First distributed. 84 capsules.

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Documentation 88

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

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Adverse Reactions Documentation Medical Schools Packaging 75

European Pharmaceutical Review

NOVEMBER 15, 2022

Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that. There is also encouragement to use tools where possible to increase validation efficiency and defect detection. .

Documentation 85

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 85

European Pharmaceutical Review

DECEMBER 16, 2022

The 2022 updates include a new recommendation on the use of a novel all-oral six-month regimen made up of bedaquiline, pretomanid, linezolid and moxifloxacin (BPaLM) for patients with MDR/RR-TB or MDR/RR-TB with additional resistance to fluoroquinolones (pre-XDR-TB). Who can utilise the World Health Organization’s 2022 update?

Documentation 86

Documentation 86

Hospital Pharmacy Europe

SEPTEMBER 26, 2023

The PSA said that it has had concerns ‘in recent years’ about the time that the GPhC takes to deal with FtP cases, and that the position had not improved in the period from 1 July 2022 to 30 June 2023. This was significantly more than the previous year, and follows a steady increase since 2019.

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Documentation Hospitals 105