This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
The Cell and Gene Therapy (CGT) Catapult has published its ‘ UK Advanced Therapy Medicinal Products (ATMP) Clinical Trials Report 2022 ’. The research observed this cell type took up 58 percent of UK ATMP clinical trials in 2022. . The number of Phase II/III trials increased from three trials in 2021 to seven trials in 2022.
Reflecting back on our favorite photographs from 2022, we are struck by how many portraits were in our selection. These images also document a pipeline program for Indigenous medical students, an incarcerated person fighting for better hepatitis C care, and a trailblazing Alzheimer’s researcher.
This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. Regulation, particularly Annex 1, was identified as a key focus for 2022.
Large hospital systems’ investments rebounded heavily in the final quarter of 2022, according to a new STAT analysis of financial filings. STAT analyzed the financial documents of 37 tax-exempt, not-for-profit health systems covering the last three months of 2022.
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. read more
The International Generic and Biosimilar Medicines Association (IGBA)’s new whitepaper Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline suggests how the guideline provides great opportunity to revaluate how regulatory requirements can better advance biosimilar access. WHO Biosimilar Guideline updates.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
(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.
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.
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.
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.
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.
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.
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.
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.
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”.
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.
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.
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.
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.
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.
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.
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.
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.
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. .
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. .
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?
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
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 .
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.
. “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.
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.
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”.
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.
We organize all of the trending information in your field so you don't have to. Join 5,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content