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As the healthcare sector grows, there is a clear trend towards the expansion of biologic therapeutic drugs and vaccines like the one developed by Novavax. To summarise, bioproduction hurdles include the necessity to be fast, agile and, not to be understated, able to deliver safe and effective vaccines worldwide. 2021 [cited May 2022].
The failure of the European Commission to locate text messages between its president Ursula von der Leyen and Pfizer chief executive Albert Bourla on procurement of COVID-19 vaccine has earned a rebuke from the EU Ombudsman. billion doses of Pfizer and BioNTech’s vaccine. billion doses of Pfizer and BioNTech’s vaccine.
For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Accessed 7 September 2021.
In this article five tips for incoming PGY2 pharmacy residents is provided. BCPS, BCIDP Article posted: 12 May 2023 The ASHP pharmacy residency match phases 1 and 2 have come to a close. Core resources can include society guidelines, ACCP Self Assessment Program chapters , review articles, key specialty books (e.g.,
This article will focus on how dogs function as service animals, including the health benefits they provide to their owners and how you may qualify for one. This definition extends to those with a documented history of such an impairment, even if they are not presently experiencing a disability. What is a service animal?
I saw a statistic in a Health Europe article, published in September this year, which reported that 81% of patients do not feel listened to by pharma companies. Through this outcomes measurement tool, patients keep comprehensive diaries of their condition, documenting what aspects of the disease affect them most.
This article will discuss pharmaceutical validation, its benefits, types, and basic recommendations. It also requires documenting the entire process, from raw material sourcing to product launch. Process design should be based on solid evidence and include thorough documentation. Keep on reading!
In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). This article highlights the regulatory expectations of raw materials, the challenges of postapproval changes. and the impact on supply resiliency.
The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience. 08.30 – 12.30.
This article outlines a broad framework to evaluate different types of modalities that may be accommodated concurrently in a new or existing facility and then uses a case study to explain how the approach may be applied to an existing facility. For the purposes of brevity, this article doesn’t discuss safety. Complete Data Gathering.
In a new viewpoint article from PQA, Merck and the University of Arizona College of Pharmacy, we present three reasons for new MTM quality measures and offer recommendations on next steps to achieve this. Additional medical services beyond vaccinations are becoming more routine at pharmacies. data sources), and usability.
Among the many effects the Covid-19 pandemic has had on the pharmaceutical industry is a substantial increase in the number of AEs being reported from drug trials, due to the fast-tracked development, approval and marketing of vaccines for the SARS-CoV-2 virus. Redesigning the translation process to increase efficiency.
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In the October 2021 edition of the American Journal for Managed Care, EQUIPP® was highlighted in an article on how a collaborative effort of MAPD plans with community pharmacies could impact vaccination rates for pneumonia and influenza by providing low site of care cost immunizations to the populations served. Sheer et al.,
This article presents relevant insights on the current regulatory and technical landscape for decentralized manufacturing, with select examples of current applications, and discusses perspectives on evolving and adapting the current regulations to meet future capabilities. Genetic Engineering and Biotechnology News. 5 October 2022.
It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Dr Gouws added that WHO was the only regulatory authority to have performed inspections of Chinese manufacturers of Covid-19 vaccines during the pandemic.
This article offers highlights from the discussion. A highlight of the session was the mutual praise from industry and regulators on how well the two parties worked together during the pandemic to bring vaccines and drugs to the patients in record time. Attendees were invited to submit questions to the FDA representatives.
The European Commission’s failure to reveal text messages between president Ursula von der Leyen and Pfizer chief executive Albert Bourla on COVID-19 vaccine procurement has earned it a formal rebuke from the EU Ombudsman. billion doses of Pfizer and BioNTech’s vaccine. billion doses of Pfizer and BioNTech’s vaccine.
Okudaira of PMDA agreed that communications may be a driving force of acceptance of new models, and also establishing international convergence documents may help. A 2020 pilot invited external authorities to participate and observe EMA procedures authorizing COVID-19 vaccines and therapeutics. 2022 ISPE Annual Meeting & Expo.
Most of the time they want to pick my brain on where pharmacy is going or what could be possible, so with that being the case, I thought it would be better to put this article together that may help potentially interested parties. Even some of the most recent pitches are very similar to each other I feel. So let's get started!
Oxford University has suspended a clinical trial of its AstraZeneca-partnered COVID-19 vaccine in children and adolescents while a possible link to rare cases of blood clotting is investigated by the UK drugs regulator. . MHRA Chief Executive Dr June Raine reminds everyone to report side effects of Covid-19 vaccine to the #YellowCard scheme.
Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. With blockchain, every step a pharmaceutical product takes in the supply chain journey is documented through an immutable record of events.
In an article published in the Journal of GXP Compliance , Moldenhauer explained what can be learned from the observations for a vaccine production facility published in a redacted FDA 483 Report as an example. Operator training on such a procedure was also not documented and the company failed to sufficiently investigate the incident.
Have all requested documents ready and easily accessible. The panel was asked about some of the challenges that inspectors had found when inspecting manufacturers of mRNA vaccines or cell-based medicines. It has not been vetted by any of the agencies or regulators cited in this article. Other General Questions.
The rest is history: vaccines were delivered worldwide in record time, saving millions of lives. In this article, we will explore the main use cases for cloud computing in pharmaceutical industry, its benefits, and the challenges that still need to be addressed.
In this article, you will learn: What the GI-MAP stool test can identify Previously identified patterns New patterns and other interesting findings What the GI-MAP Stool Test Can Identify The Gastrointestinal Microbial Assay Plus (GI-MAP®) is a test from Diagnostic Solutions Laboratory that I frequently recommend to clients. If you have H.
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