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1 Natural disasters have reached unprecedented levels in the past 5 years, with 2020, 2023, and 2024 being the most destructive and costly since before 1980. Aside from properly preparing medications during a disaster, Phillips mentioned the importance of establishing communication with patients.
While it officially applies to the manufacture of sterile medicinal products in the European Union, the revised EU Good Manufacturing Practice (GMP) Annex 1 effectively reset the benchmark for quality standards across the globe on 25 August 2023. Register your details to read more The post How ready are you?
Assessing drug manufacturing facilities using alternative tools The FDA stated in the guidance that all manufacturing, packaging, and control sites for drug substance and drug product facilities are expected to be ready for inspection at the time of application submission.
These chemicals are everywhere and have been used in many ways over the decades, bringing a range of benefits from water- and stain-resistant coatings and firefighting foams to nail polish and food packaging. However, the world is now learning they are also persistent pollutants that contaminate our soil, water and air.
This much-anticipated independent review, commissioned by the Government in February 2023, offers 27 recommendations, addressing eight problem statements, on how the Government should work to resolve key challenges in conducting commercial clinical trials in the short and longer term.
In August 2023, the therapy received investigational new drug clearance from China’s National Medical Products Administration to start a Phase I cancer trial. We may still continue to send you service-related and other non-promotional communications. Sign up for our daily news round-up!
7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 References European Commission, (26 April 2023). Euractiv (6 October 2023). European Commission (26 April 2023). Article 63 Euractiv (26 September 2023).
For example, Recordati’s Cystadane (betaine) was centrally approved in 2007 but did not see its first reimbursement in Poland until 2023. compared to 861 days in 2023. compared to 2023. In certain cases, products approved over 17 years ago are seeing their reimbursement inclusion.
Innovator oligonucleotide-based drugs targeting central nervous system (CNS) indications witnessed a 339% ($2.17bn) increase in total licensing agreement deal value from 2023 to 2024, reaching a total deal value of $2.81bn, according to GlobalData’s Pharma Intelligence Center Deals Database. Credit: Kateryna Kon via Shutterstock.
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By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023.
APAC Pharma Challenges — The Viseven Event Summary, April 2023 Digital maturity, personalized customer engagement, and data-driven marketing have been accepted and implemented in Europe and the US for a few years. As of 2022, APAC accounts for 57% of Phase I clinical trials and 49% of Phase II clinical trials worldwide.
In 2023, a study found that a clinical trial patient matching tool was able to reduce pre-screening checking time for physicians by 90%, by leveraging Large Language Models (LLMs) [iv]. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
From cave paintings to emails, we now communicate faster, clearer, and from greater distances. You may unsubscribe from these ISPE communications at any time. Download White Paper To download this white paper, complete the form below. Once submitted, you will receive a link via the email you provided to download the white paper.
As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging.
All communications, both internal and external, should reflect the brand’s values and personality. This includes everything from the company’s website and social media presence to packaging and advertising. This can include creating a brand mission statement, defining brand values, and developing a brand personality.
Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities. By Li Jie of ClinsChain
2022 ISPE China Pharmaceutical Supply Chain Summit Trudy Patterson Tue, 03/28/2023 - 09:24 iSpeak Blog iSpeak 2022 ISPE China Pharmaceutical Supply Chain Summit 28 March 2023 On 17 December 2022, more than 100 people from all over the world gathered online for the 2022 ISPE China Pharmaceutical Supply Chain Summit.
In 2023, SpliceBio signed a licensing agreement with Spark Therapeutics, allowing the latter to use its protein splicing platform and develop a gene therapy for an undisclosed inherited renal disease. We may still continue to send you service-related and other non-promotional communications. Sign up for our daily news round-up!
™ Roadmap Trudy Patterson Thu, 05/11/2023 - 13:25 Technical May / June 2023 Methodology to Define a Pharma 4.0™ ™ Roadmap Emmie Heeren AREND JAN WASSINK Venkateshwar Rao Nalluri, PhD Sebastian NIEDERHAUSER 1 May 2023 In the context of data integrity, data flows are essential. Methodology to Define a Pharma 4.0™ to Industry 4.0
BCPS, BCIDP Article Posted 1 December 2023 Podcasting has emerged as an incredible way to reach a global audience and discuss scientific information. Not being afraid to communicate with people has been important to my success. Interviewee: Luis Plaza Interviewer: Timothy P. Gauthier, Pharm.D.,
The survey was distributed via an email communications to ISPE members, a blog on ISPE’s website, and LinkedIn postings. This provided impetus for the survey whose goal was to identify users’ current practices and views on what they would like to see happen.
There was a small mix up with communication that Oscar had bloods done at school, so we had a couple of messages saying they were doing it at home, when in fact they were doing it at school as usual during term time. But we like these and will continue to use them when needed (ie not when its 27 degrees Celsius outside!).
Pilot participants were provided a technical package containing all resources needed to accurately calculate the SP-TAT-PH measure. For example, one participant described how varying levels of “urgency” could be communicated to pharmacists, empowering them to prioritize prescriptions for expedited review.
Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. On a regular basis, pharmaceutical manufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.
In the first 2023 edition of the CMO Moves monthly series , Pharmaceutical Technology explores recent news stories on regulatory and reimbursement decisions in different countries, and the companies linked to their success and failures. Please check your email to download the Report.
Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.
A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Features May / June 2023 A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. Currently, it takes time and/or communications (e.g., Brown Megan E. McMahon Timothy J.N.
In 2023, the Royal College of Emergency Medicine and the UK Clinical Pharmacy Association recommended all EDs have a dedicated pharmacist and, as of 2024, approximately 77 of 170 UK EDs (45%) have a clinical pharmacy service. 10 The same study found that ED pharmacists generally had a broad and often detailed knowledge of safeguarding.
A Proposal for a Comprehensive Quality Overall Summary Trudy Patterson Wed, 03/29/2023 - 13:14 Online Exclusives A Proposal for a Comprehensive Quality Overall Summary Roger Nosal Connie Langer Beth Kendsersky Jennifer L. Currently, it takes time and/or communications (e.g., Brown Megan E. McMahon Timothy J.N.
CMC Requirements for New Drug Registration in Latin America Trudy Patterson Tue, 05/09/2023 - 11:23 Features May / June 2023 CMC Requirements for New Drug Registration in Latin America Aicha Otmani Flavia C. Among the additional tests required are in-process control tests and primary packaging type and material.
Environmental Sustainability in Biopharmaceutical Facility Design Trudy Patterson Wed, 03/15/2023 - 09:13 Online Exclusives March / April 2023 Environmental Sustainability in Biopharmaceutical Facility Design William G. A Strategy for the Sector 2023–2027.” Table 1: Facility environmental sustainability tools and example values.
Sustainability: Corporate Ambition, Governance, & Accelerated Delivery Trudy Patterson Tue, 03/07/2023 - 09:14 Features March / April 2023 Sustainability: Corporate Ambition, Governance, & Accelerated Delivery Guy Wingate, PhD Ylva Ek Patricia M. Communicating keynote successes will help encourage engagement and support.
Challenges for Net Zero Carbon Pharmaceutical Manufacturing Trudy Patterson Mon, 03/06/2023 - 12:40 Features March / April 2023 Challenges for Net Zero Carbon Pharmaceutical Manufacturing Keith M. solvent selection, inhaler propellant replacement, and packaging design) to employee travel and commute policy (e.g.,
Trudy Patterson Mon, 09/11/2023 - 06:10 Features September / October 2023 Air Speed Qualification: At Working Position or Working Level? 3 Lastly, the WHO published the new guideline under their framework in January 2023 as Annex 2. x, a free and open-source computational fluid dynamics (CFD) software package.
The latest funding boost supplements an earlier announcement made during the 2023-24 budget, which provided A$25m in recurrent funding dedicated to similar initiatives. We may still continue to send you service-related and other non-promotional communications. Sign up for our daily news round-up!
Antiviral Biktarvy is the company’s top-selling HIV drug, generating global revenue of $13.4bn in 2024, an increase of 13% compared to 2023. Gilead already has several approved HIV treatments and prevention options in the US. Give your business an edge with our leading industry insights.
Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.
The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. Among other things, supply chain optimisation, maintaining access to affordable vaccines, and supporting innovation for unmet clinical needs will be the discussion topics, she adds.
According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.
It seems like yesterday, and now the 2022 ISPE Annual Meeting & Expo in Orlando, Florida, has come and gone, and Mike Rutherford is the 2022–2023 Chair. This interaction was used to further improve the ISPE Charter, and the proposed changes will be implemented into the 2023 version. One ISPE and Strategic Plan Refresh.
The recent National Child Mortality Database (NCMD) thematic report 6 analysed deaths over a four-year period from April 2019 to March 2023 in children with confirmed or suspected asthma as the cause of death. Learnings from the CDOPs showed that allergy symptoms were not always communicated to healthcare professionals.
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