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Do you know everything about return saleables? Do you know how to use it as a stepping stone to achieve DSCSA compliance? What are the critical success factors determining the success of verified return saleables? The article talks in details about the warehouse equipment required for VRS, the right tools required for verification, and the storage requirements during the VRS process.
The VRS-compliance deadline may have been pushed by 3 years, but following the journey to complete compliance, be it VRS or others, continues. The drug supply chain stakeholders were on their toes to get the right equipment to ensure that a delay in compliance does not come in their supply chain management. Now, they can relax and take their time for compliance. However, the need of supervision still remains.…
VRS-compliance is merely a part of DSCSA compliance. But that’s not enough because there are a number of things that need to be considered while achieving one milestone at a time. So, here’s a checklist with all the important pre-requisites for DSCSA compliance by 2023. Some of the important points of discussion would be the importance of FDA-NDC, what are FDA labelers, and how multiscanners help in streamlining VRS compliance with the help of look-up directories and FDA labelers.
According to WHO, one in 1 in 10 products in developing countries are found to be fake, which not only lead to fatalities but also dupes the economy of close to $200 billion annually. Each year close to 250,000 children die because of consumption of counterfeit drugs and similar effects are visible among the elde…
Demanding, high-volume document and data processing-based tasks make Regulatory operations administratively labour-intensive, so interest in robotic process automation is understandable. But where is the technology’s ideal application, and how can life sciences firms extract maximum benefits? Amplexor’s Agnes Cwienczek offers a reality check.
Demanding, high-volume document and data processing-based tasks make Regulatory operations administratively labour-intensive, so interest in robotic process automation is understandable. But where is the technology’s ideal application, and how can life sciences firms extract maximum benefits? Amplexor’s Agnes Cwienczek offers a reality check. The potential for transforming workload management in Regulatory operations using robotic process automation (R…
The continuing pandemic has disrupted everything in life sciences, including European regulatory activity. So simplified and more flexible authorisation procedures are proving very welcome in keeping supply chains moving. Monia Nica, Senior Regulatory Affairs Manager at Arriello, summarises the temporary changes to requirements.
The continuing pandemic has disrupted everything in life sciences, including European regulatory activity. So simplified and more flexible authorisation procedures are proving very welcome in keeping supply chains moving. Monia Nica, Senior Regulatory Affairs Manager at Arriello, summarises the temporary changes to requirements. Agencies across Europe have joined forces to determine how best to maintain medicines availability as the pandemic continues to wreak havoc…
With employers looking to develop and improve the soft skills of their employees, nearly 300 of the 2020 Fortune 500 companies now offer in-house Toastmasters clubs to help build their employees’ communication, leadership, and public speaking skills. Toastmasters International, the world's leading organization devoted to communication and leadership skills development, is particularly popular among pharmaceutical companies, with industry giants including Johnson & Johnson and Pfizer offering corporate clubs to their employees.
Fortune 500 Companies Count on Toastmasters to Develop Employees’ Skills All of the top 20 Fortune 500 companies have at least one Toastmasters club   With employers looking to develop and improve the soft skills of their employees, nearly 300 of the 2020 Fortune…
Finland based oil refining and marketing company Neste, Oyj has entered into a pact with the South Korean chemical giant LG Chem, aiming to produce the biopolymers and biochemicals globally.
Finland based oil refining and marketing company Neste, Oyj has entered into a pact with the South Korean chemical giant LG Chem, aiming to produce the biopolymers and biochemicals globally. As per the pact, LG Chem will replace the fossil feedstocks used for manufacturing polymers and chemicals with ‘Neste Renewable Hydrocarbons’ in the near term, thereby lending its significant contribution towards transforming the world into a circular bioeconomy. Get more info : https://www.chemanalyst.com/NewsAndDeals/DealsDetails/lg-chem-and-neste-collaborate-to-produce-bio-based-polymer-resins-77 The partnership…
The UK formally left the EU on 31st January 2020 and the transition period, as set out in the withdrawal agreement, will come to an end on 31st December 2020. During this transition period the UK has continued to remain under EU pharmaceutical law. From 1st January 2021 the UK will be able to adopt an independent regulatory framework with the Medicines and Healthcare products Regulatory Agency (MHRA) positioned as the stand-alone regulator for medicines and medical devices.
Brexit White Paper Introduction The UK formally left the EU on 31st January  2020 and the transition period, as set out in the withdrawal agreement, will come to an end on 31st December  2020. During this transition period the UK has continued to remain under EU pharmaceutical law. From 1st January 2021…
Both the Gut and nervous system communicate regularly through the "nervous system language" to perform the various functions. This useful interaction of Gut and the nervous system helps Gut to respond to the variety of dietary products that it absorbs, the broad spectrum of pathogens that it encounters, and the diverse microbiome that it harbors To understand the Leaky gut syndrome, one need to get aware of Autonomic nervous system.
Introduction Both the Gut and nervous system communicate regularly through the "nervous system language" to perform the various functions. This useful interaction of Gut and the nervous system helps Gut to respond to the variety of dietary products that it absorbs, the broad spectrum of pathogens that it encounters, and the diverse microbiome that it harbors [1]…
Pharmaceutical manufacturers are being urged to review their anti-counterfeiting plans ahead of the possible failure by the UK government to agree a Brexit deal with the EU.
PHARMAS URGED BY TRADE BODY TO REVIEW ANTI-COUNTERFEITING PLANS AHEAD OF NO BREXIT DEAL   Pharmaceutical manufacturers are being urged to review their anti-counterfeiting plans ahead of the possible failure by the UK government to agree a Brexit deal with the EU.   Global trade body International Hologram Manufacturers Association (IHMA) said the UK could see a flood of counterfeit medicines after the Falsified Medicines Directive (FMD) ceases to apply at the end of the Brexit transition period on 1st January 2021.   In place since early 2019, the FMD utilises mandatory safety features and an EU-wide dat…
Oxygen is vital element for sustaining life on the planet earth. It is used extensively in hospital for serving various medical purposes.
Oxygen is vital element for sustaining life on the planet earth. It is used extensively in hospital for serving various medical purposes. Medical oxygen is administered to patients suffering from health disorders such as breathlessness, hypoxemia, asthma, COPD, trauma, resuscitation and so on. Oxygen administered must be of high purity. We are leaders in manufacturing and supplying medical oxygen manufacturing plant with superb designing and advanced cryogenic technology considered the best choice for production high purity oxygen. Equipped To Produce Medical Grade Oxygen It is too well-known to reiterate that oxygen administered for medical purposes mus…
GDm-Health™ is a digital therapeutic comprising of a smartphone app connected to a wireless blood glucose monitor, which helps mothers-to-be and their clinical care teams manage diabetes during pregnancy. According to the National Institute for Health and Care Excellence, 5% of pregnant women in England and Wales have some form of diabetes. If this is not monitored or managed effectively, it can cause serious problems for both the child and mother.
Overview GDm-Health™ is a digital therapeutic comprising of a smartphone app connected to a wireless blood glucose monitor, which helps mothers-to-be and their clinical care teams manage diabetes during pregnancy. According to the National Institute for Health and Care Excellence, 5% of pregnant women in England and Wales have some form of diabe…
Oculis S.A., a biopharmaceutical company focused on developing transformative topical ophthalmic treatments to improve the sight and lives of patients, announces the appointment of David Jacobs, M.D., as Chief Development Officer.
Oculis appoints David Jacobs, M.D. as Chief Development Officer adding complementary drug development and regulatory expertise LAUSANNE, Switzerland, October 22, 2020 – Oculis S.A., a biopharmaceutical company focused on developing transformative topical ophthalmic treatments to improve the sight and lives of patients, announces the appointment of David Jacobs, M.D., as Chief Development Officer. Dr. Jacobs will be  based in Oculis’ newly established U.S. office. In this new role, he will be responsible for leading all development plans and achieving market…
The growing importance of Northern Ireland’s pharmaceutical and life sciences industries is revealed today [Tuesday 20 October 2020] in a new report tracking the significant contribution the sector makes to the NI economy.
Research by the Fraser of Allander Institute reveals that the life science sector is thriving, supporting 18,000 full-time jobs throughout NI.  The sector has seen a boom in recent years with employment in both pharmaceuticals and medicines manufacturing increasing by 6% since the last tally in 2015, and wider life sciences employment increasing by 12% in the same period. NI Pharma Report 2020.pdf The report’s authors point to global advances in biomedical research originating in Northern Ireland, including developments in cancer, cardiovascular disease, and cystic…
People need greater personal incentives to convince them to use COVID-19 tracing apps, according to a new report from Imperial College Business School.
People need greater personal incentives to convince them to use COVID-19 tracing apps, according to a new report from Imperial College Business School. The report also suggests that the sharing of NHSx self-isolation data with the police, a move confirmed on Friday evening by the Department of Health and Social Care, would have a negative effect on the adoption of the app by the public. The researchers state that this would increase the private cost to the potential adopter without providing any countervailing benefit to the individual. According to the report, ‘Privacy, Adoption and Truthful Reporting: A Simple Theory of Contact Tracing App…
Justin Eames, Senior Manager, APM Solution Consulting, Aspen Technology Inc, looks at asset failure and explains how predictive analytics could help manufacturers avoid expensive over-maintaining
Counting the Cost of Asset Failure   Justin Eames, Senior Manager, APM Solution Consulting, Aspen Technology Inc, looks at asset failure and explains how predictive analytics could help manufacturers avoid expensive over-maintaining       Asset failure is simply not an option for pharmaceutical companies today. Interrupting the production and supply of drugs is likely to mean they lose out to the competition and will negatively impact on customer loyalty. To prevent any possibility of this happening, many manufacturers across the sector indulge in expensive over-m…
Many previous studies, including a recently published paper in the Journal of Personality and Social Psychology by Dr. Robert Levenson and Dr. Kuan-Hua Chen at the University of California, Berkeley, has found that couples with higher relationship satisfactions showed greater linkage in their physiological responses (for example, heart rate and skin conductance) during face-to-face interactions, which suggests a greater “biological connection” between the couples.
UC Berkeley Partners with Tracmo to Support the Physical & Mental Health of Caregivers and Dementia Patients   Industry Background Many previous studies, including a recently published paper in the Journal of Personality and Social Psychology by Dr. Robert Levenson and Dr. Kuan-Hua Chen at the University of California, B…
The Axeos 3D/2D imaging system offers a large range of fields of views (FoV), high image quality and low dose exposure for a better customer experience.
iData Research analysts have found that the continually expanding line of Orthophos devices has given Dentsply a broad range of devices to suit all a clinic’s needs, the Axeos is another addition to their already large suite of devices.   The large range of FoV’s allows for many different treatment areas, including specialized 3D imaging. The new unit offers outstanding imaging quality with intelligent low dose exposure while maintaining a high level of patient and user comfort. The Axeos includes smart height adjustments and quick scan times, resulting in exceptional patient experiences. Further accessibility can be provided…
There are multitude of ways in which we’re seeing consumer technology influence healthcare. With the normalisation of things like IoT, wearable tech, and video conferencing as part of our daily lives, patients are starting to expect the same level of tech from healthcare providers.
There are multitude of ways in which we’re seeing consumer technology influence healthcare. With the normalisation of things like IoT, wearable tech, and video conferencing as part of our daily lives, patients are starting to expect the same level of tech from healthcare providers. The world of medicine is defined by innovation and the search for new solutions to provide ever better treatment, and with billions of pounds worth of innovation constantly happening in the consumer sector, it makes total sense for hea…
The continuing pandemic has disrupted everything in life sciences, including European regulatory activity. So simplified and more flexible authorisation procedures are proving very welcome in keeping supply chains moving. Monia Nica, Senior Regulatory Affairs Manager at Arriello, summarises the temporary changes to requirements
Agencies across Europe have joined forces to determine how best to maintain medicines availability as the pandemic continues to wreak havoc on international supply chains. The result is a new set of guidelines for the exceptional circumstances from the European Commission (EC), in collaboration with the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), and the European Medicines Agency (EMA): 1.      …
It would be an understatement to say that oxygen is the most important element on the planet earth. It is too well-known a fact as everyone knows that life cannot sustain itself.
It would be an understatement to say that oxygen is the most important element on the planet earth. It is too well-known a fact as everyone knows that life cannot sustain itself. Use of oxygen is vital for treating patients suffering from low oxygen level also called as hypoxemia. It is used in the treatment of patients with health conditions like chronic asthma, cystic fibrosis, pulmonary hypertension, obstructive sleep apnea, heart failure, case of anaphylaxis, major trauma and seizure or hypothermia. In the wake of COVID-19, demand for medical oxygen has really spiraled like never.  In order to meet the inc…