STAT

SEPTEMBER 16, 2024

In 2022, Medtronic recalled more than 85,000 of the devices after dozens of complaints that a technical glitch could stop them from delivering the right, high-voltage shock.  Among the 157 cardiovascular devices impacted by those serious recalls, only 30 had clear documentation of premarket clinical testing.

Documentation 129

Documentation FDA 129

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.

Documentation 145

Documentation Insurance 145

OctariusRx

SEPTEMBER 12, 2022

OctariusRx President and Consultant Pharmacist Victor Alves is presenting “Medication Management: Acing your next Survey” at the 2022 Northeast Conference, presented by the Massachusetts Association of Ambulatory Surgery Centers. The post Victor Alves Presenting at the 2022 Northeast Conference appeared first on OctariusRX.

Controlled Substances 78

Controlled Substances Documentation 78

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.

Documentation 246

Documentation 246

Drug Topics

NOVEMBER 3, 2023

By way of natural immunity, vaccination, and behavior change, the majority of the 30,861 documented cases and 54 deaths were confined to 2022, and the epidemic curve portrays a picture of success.

Documentation 98

Documentation Immunization Vaccines 98

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.

Documentation 105

Documentation Pharmaceutical Companies Pharmaceutical Companies 105

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.

Method Validation 98

Method Validation Documentation FDA 98

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.

Documentation 128

Documentation 128

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.

FDA 98

FDA Insurance Chemotherapy Documentation 98

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.

FDA 125

FDA Documentation 125

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

OCTOBER 28, 2022

Fri, 10/28/2022 - 09:32. November / December 2022. 1 November 2022. Application of engineering change management (ECM), engineering document management, and engineering issue management throughout the C&Q process can significantly reduce time, cost, effort, and risk. Enabling More Efficient and Effective C&Q Through GEP.

Documentation 98

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.

FDA 123

FDA Documentation Insurance 123

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.

Documentation 52

Documentation Compounding Communication FDA 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.

Documentation 97

Documentation Communication 97

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

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

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

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

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.

Documentation 105

Documentation Vaccines 105

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.

Documentation 98

Documentation FDA 98

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.

Documentation 98

Documentation 98

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

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.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

European Pharmaceutical Review

FEBRUARY 1, 2023

This follows a one-year transition, during which sponsors could choose whether to apply for a new clinical trial in the EU/EEA in line with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which entered into application on 31 January 2022. The CTR foresees a three-year transition period, from 2022 to 2025.

Documentation 104

Documentation 104

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

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 98

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 98

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. .

Medical Schools 52

Medical Schools Documentation Insurance 52

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 98

Documentation 98

European Pharmaceutical Review

NOVEMBER 23, 2022

The QIG, set up in September 2022, is composed of eight members with backgrounds in chemical, biological quality assessment and Good Manufacturing Practice (GMP) inspections, who report under the Quality Domain of EMA’s working party structure. Prepare guidance documents related to innovative quality and manufacturing technologies .

Documentation 111

Documentation 111

European Pharmaceutical Review

NOVEMBER 14, 2023

In the document, it was reasoned that global shortage of these vials threatened the delivery of COVID-19 vaccines and availability of existing parenteral products.

Packaging 105

Packaging Vaccines Documentation FDA 105

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

FDA 105

FDA Documentation 105

European Pharmaceutical Review

NOVEMBER 9, 2022

. “Some key considerations for a GMP manufacturing suite include space utilisation, expected process workflow, operator headcount, materials quality and specifications, and documentation suitability for batch records and process descriptions with outlined unit operations.” 2021 [Cited 16 September 2022]. Globaldata.com.

Vaccines 115

Vaccines Documentation Communication Hospitals 115

pharmaphorum

NOVEMBER 15, 2021

Under the EU clinical trial regulations, explained EFPIA’s Science Policy and Regulatory Senior Manager Silvia Garcia, sponsors will be required to publish a lay summary of all trial results from February 2022. This should cover the entire process, “starting with the writing, the review of the document, and its dissemination”.

Documentation 98

Documentation Communication Hospitals 98

The FDA Law Blog

JANUARY 10, 2023

20, 2022, FTC announced the publication of its Health Products Compliance Guidance (“new Guidance”). An accompanying blog post touts the new Guidance as potentially “one of the most important documents you’ll read in 2022.” By Riëtte van Laack & Ricardo Carvajal — On Dec.

Documentation 105

Documentation 105

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