Articles
Regulatory teams have much to learn from the standardised approach that quality assurance colleagues take to managing information. The legacy, document-based view of information management is fast being replaced by a data-first approach. Up-to-date, high quality data is key to success, argues Romuald Braun, VP of Strategy for Life Sciences, AMPLEXOR.
Regulatory teams have much to learn from the standardised approach that quality assurance colleagues take to managing information. The legacy, document-based view of information management is fast being replaced by a data-first approach. Up-to-date, high quality data is key to success, argues Romuald Braun, VP of Strategy for Life Sciences, AMPLEXOR. Across pharma businesses, teams work together to meet Regulatory commitments, perhaps sharing u…
Regulatory teams have much to learn from the standardised approach that quality assurance colleagues take to managing information. The legacy, document-based view of information management is fast being replaced by a data-first approach. Up-to-date, high quality data is key to success, argues Romuald Braun, VP of Strategy for Life Sciences, AMPLEXOR. Across pharma businesses, teams work together to meet Regulatory commitments, perhaps sharing u…
Here's a list of awareness days for Healthcare and Pharma for 2020. Note that this is not an exhaustive list, and if you spot any errors or omissions, let me know.
January National Blood Donor Month National Glaucoma Awareness Month National Volunteer Blood Donor Month Cervical Cancer Awareness Month National Birth Defects Prevention Month Dry January 19-25th: National Activities Professional Week 25th: National Intravenous Nurse Day February American Heart Month AMD/Low Vision Awareness Month National Cancer Prevention Month National Senior Independence Month Feb. 1-7: Patient Recognition Week Feb. 3-7: Pride in Food Service Week Feb. 9-15: National Cardiac Rehabilitation Week Feb. 14-21: Alzheimer's and Dementia Staff Education Week February 4th: World Cancer Day …
January National Blood Donor Month National Glaucoma Awareness Month National Volunteer Blood Donor Month Cervical Cancer Awareness Month National Birth Defects Prevention Month Dry January 19-25th: National Activities Professional Week 25th: National Intravenous Nurse Day February American Heart Month AMD/Low Vision Awareness Month National Cancer Prevention Month National Senior Independence Month Feb. 1-7: Patient Recognition Week Feb. 3-7: Pride in Food Service Week Feb. 9-15: National Cardiac Rehabilitation Week Feb. 14-21: Alzheimer's and Dementia Staff Education Week February 4th: World Cancer Day …
Investing in structured content management/authoring capabilities without first establishing a supporting backbone is like buying a Porsche when there are no suitable roads to drive on. Amplexor’s Agnes Cwienczek suggests a more sustainable approach.
Today, there are numerous external and internal drivers for life sciences organisations to be collecting, preparing, publishing/submitting and managing more and more data, and to be doing this more and more using a structured format. Regulatory agencies are demanding increased safety and traceability detail; requirements about what goes on packaging and labelling are becoming more stringent; and the public is calling for greater transparency about the products they use. Meanwhile, companies need to be smarter, faster and more cost-efficient in…
Today, there are numerous external and internal drivers for life sciences organisations to be collecting, preparing, publishing/submitting and managing more and more data, and to be doing this more and more using a structured format. Regulatory agencies are demanding increased safety and traceability detail; requirements about what goes on packaging and labelling are becoming more stringent; and the public is calling for greater transparency about the products they use. Meanwhile, companies need to be smarter, faster and more cost-efficient in…
Providing electronic product information, something international health authorities are steadily moving towards as a requirement, promises to be a much more efficient and user-friendly way of conveying the latest manufacturing details and safety recommendations to patients and healthcare professionals. But how ready are life sciences companies, asks Amplexor’s Agnes Cwienczek.
Providing electronic product information, something international health authorities are steadily moving towards as a requirement, promises to be a much more efficient and user-friendly way of conveying the latest manufacturing details and safety recommendations to patients and healthcare professionals. But how ready are life sciences companies, asks Amplexor’s Agnes Cwienczek. Continued reliance on paper-based ins…
Providing electronic product information, something international health authorities are steadily moving towards as a requirement, promises to be a much more efficient and user-friendly way of conveying the latest manufacturing details and safety recommendations to patients and healthcare professionals. But how ready are life sciences companies, asks Amplexor’s Agnes Cwienczek. Continued reliance on paper-based ins…
PharmiWeb is pleased to announce the launch of our IOS Job Search App for the pharma and life science sector.
PharmiWeb is pleased to announce the launch of our IOS Job Search App for the pharma and life science sector. Even in these times, PharmiWeb’s niche job board (PharmiWeb.Jobs) maintains a vast selection of active job vacancies from countries right across Europe and into Australia. The new app is designed to help job seekers quickly search over 2500 current vacancies from more than 80 actively recruiting employers and agencies. Once installed, job seekers can save their searches, shortlist the roles or apply online using their hand held devices. Developed by our platform partner Madgex, our IOS app complements our existing Android app already available on the Google App…
PharmiWeb is pleased to announce the launch of our IOS Job Search App for the pharma and life science sector. Even in these times, PharmiWeb’s niche job board (PharmiWeb.Jobs) maintains a vast selection of active job vacancies from countries right across Europe and into Australia. The new app is designed to help job seekers quickly search over 2500 current vacancies from more than 80 actively recruiting employers and agencies. Once installed, job seekers can save their searches, shortlist the roles or apply online using their hand held devices. Developed by our platform partner Madgex, our IOS app complements our existing Android app already available on the Google App…
Why are Safety & Pharmacovigilance departments lagging in their application of smart technology, when the pressures on pharmaceutical organisations to capture, sift and process real-world adverse event data are vast, asks John Price, a life sciences regulatory and safety consultant and advisor to Arriello.
Compared with other functions across the pharmaceutical product lifecycle, Safety and Pharmacovigilance (PV) teams are the least likely to employ smart technology to help lighten the load. This is surprising given that life sciences companies today spend a disproportionate amount of their PV budget simply amassing reports of suspected drug reactions - which are often of poor quality. So what’s stopping them exploiting proven technology to lighten the load? Building the business case In pr…
Compared with other functions across the pharmaceutical product lifecycle, Safety and Pharmacovigilance (PV) teams are the least likely to employ smart technology to help lighten the load. This is surprising given that life sciences companies today spend a disproportionate amount of their PV budget simply amassing reports of suspected drug reactions - which are often of poor quality. So what’s stopping them exploiting proven technology to lighten the load? Building the business case In pr…
Peter Kohut, Director of Drug safety at Arriello, explores the main hurdles preventing greater automation of PV data capture processes within life sciences firms, and suggests a way forward
Peter Kohut, Director of Drug safety at Arriello, explores the main hurdles preventing greater automation of PV data capture processes within life sciences firms, and suggests a way forward. With more and more safety data to capture, and a window of just 15 days to assess and report serious adverse events to health authorities, the case for automating the most labour-intensive aspects of pharmacovigilance (PV), is strong. So, what is holding companies back from investing in process transformation? 1. A lack of suitable solutions Look at most other industries, especially thos…
Peter Kohut, Director of Drug safety at Arriello, explores the main hurdles preventing greater automation of PV data capture processes within life sciences firms, and suggests a way forward. With more and more safety data to capture, and a window of just 15 days to assess and report serious adverse events to health authorities, the case for automating the most labour-intensive aspects of pharmacovigilance (PV), is strong. So, what is holding companies back from investing in process transformation? 1. A lack of suitable solutions Look at most other industries, especially thos…
Founded in 2010, Innovative Trials works alongside pharmaceutical and clinical research organisations to ensure that patients enrol onto clinical trials in a timely manner and are fully informed of what the research will involve for themselves and their families. This enables potential new treatments to come to market as early as possible to provide alternative therapeutic options for present and future patients.
Based in Letchworth Garden City in Hertfordshire, Innovative Trials employs around 45 members of staff in the UK. The company works internationally with a further 63 people stationed overseas in 58 countries to help clinical trial researchers recruit eligible patients and keep them involved.
For more information, visit www.innovativetrials.co.uk
Clinical trial patient recruit…
Clinical trial patient recruit…
For decades now, global consumers have relied on blanket advice when it comes to their health and wellbeing, with guidance frequently centred on eating well, exercising frequently and sleeping for a recommended period per night.
Annemie Venter, R&D Director, External Product Development – Outside Innovation, Health For decades now, global consumers have relied on blanket advice when it comes to their health and wellbeing, with guidance frequently centred on eating well, exercising frequently and sleeping for a recommended period per night. Whilst these adages are still absolutely true, recent decades have witnessed significant advancements in genetics, which have paved the way for a far more personalised approach to maintaining and improving health and wellbeing. One field where these…
Annemie Venter, R&D Director, External Product Development – Outside Innovation, Health For decades now, global consumers have relied on blanket advice when it comes to their health and wellbeing, with guidance frequently centred on eating well, exercising frequently and sleeping for a recommended period per night. Whilst these adages are still absolutely true, recent decades have witnessed significant advancements in genetics, which have paved the way for a far more personalised approach to maintaining and improving health and wellbeing. One field where these…
Amplexor’s David Gwyn highlights 5 areas where richer, more holistic product information – compiled in response to regulatory requirements – could help transform business outcomes.
In the consumer world, smartphone apps are transforming people’s visibility, into their consumption habits for example, helping them to make better choices. Now the same needs to happen in life sciences, based on more unified product and regulatory status insights. In the 2020s, breaking down walls, consolidating disparate applications, and behaving more cohesively as a unified global business with end-to-end operational visibility, is a commercial imperative. Whatever the short- and longer-term fallout of Covid-19, organisations will need to come back fighting – with new tools at their disposal, ready to raise t…
In the consumer world, smartphone apps are transforming people’s visibility, into their consumption habits for example, helping them to make better choices. Now the same needs to happen in life sciences, based on more unified product and regulatory status insights. In the 2020s, breaking down walls, consolidating disparate applications, and behaving more cohesively as a unified global business with end-to-end operational visibility, is a commercial imperative. Whatever the short- and longer-term fallout of Covid-19, organisations will need to come back fighting – with new tools at their disposal, ready to raise t…
Intelligent analytics and smart process automation rely 100 per cent on the trustworthiness of underlying data. Steve Gens of Gens & Associates and Remco Munnik of Iperion Life Sciences Consultancy offer five best-practice tips for achieving and maintaining integrity across company-wide product information to create a sure footing for AI-driven innovation.
Intelligent analytics and smart process automation rely 100 per cent on the trustworthiness of underlying data. Steve Gens of Gens & Associates and Remco Munnik of Iperion Life Sciences Consultancy offer five best-practice tips for achieving and maintaining integrity across company-wide product information to create a sure footing for AI-driven innovation. ‘New’ technologies including artificial intelligence/machine learning (AI/ML) o…
Intelligent analytics and smart process automation rely 100 per cent on the trustworthiness of underlying data. Steve Gens of Gens & Associates and Remco Munnik of Iperion Life Sciences Consultancy offer five best-practice tips for achieving and maintaining integrity across company-wide product information to create a sure footing for AI-driven innovation. ‘New’ technologies including artificial intelligence/machine learning (AI/ML) o…
If standardised medicinal product data is to be of tangible real-world benefit, it’s vital that momentum around IDMP is not lost in 2020, warns Iperion’s Remco Munnik
Substantial investment has gone into the preparations for the EU’s implementation of the ISO IDMP (identification of medicinal products) standards, which must not be compromised in 2020 - whatever the current hold-ups with European Medicines Agency’s IDMP implementation guidelines, and despite the new Veterinary Regulation vying for attention. The goal of IDMP is to create a current central data repository of medicinal products that can be readily searched, understood and relied upon internationally. SPOR (Substance, Product, Organisation and Referential) data management services are the key to enabling this, paving the way fo…
Substantial investment has gone into the preparations for the EU’s implementation of the ISO IDMP (identification of medicinal products) standards, which must not be compromised in 2020 - whatever the current hold-ups with European Medicines Agency’s IDMP implementation guidelines, and despite the new Veterinary Regulation vying for attention. The goal of IDMP is to create a current central data repository of medicinal products that can be readily searched, understood and relied upon internationally. SPOR (Substance, Product, Organisation and Referential) data management services are the key to enabling this, paving the way fo…
From personalised medicine and cannabis oil, to track and trace and the Falsified Medicines Directive (FMD), the pharmaceutical industry has witnessed a whole host of changes over the past decade. But what does the future hold? Here, Adrian Pittock, marketing director at pharmaceutical consumables supplier Valley Northern, looks at pharmaceutical trends for 2020.
~ Exploring AI, blockchain and packaging ~ From personalised medicine and cannabis oil, to track and trace and the Falsified Medicines Directive (FMD), the pharmaceutical industry has witnessed a whole host of changes over the past decade. But what does the future hold? Here, Adrian Pittock, marketing director at pharmaceutical consumables supplier Valley Northern, looks at pharmaceutical trends for 2020. Artificial intelligence Ar…
~ Exploring AI, blockchain and packaging ~ From personalised medicine and cannabis oil, to track and trace and the Falsified Medicines Directive (FMD), the pharmaceutical industry has witnessed a whole host of changes over the past decade. But what does the future hold? Here, Adrian Pittock, marketing director at pharmaceutical consumables supplier Valley Northern, looks at pharmaceutical trends for 2020. Artificial intelligence Ar…
The need to boost customer choice while keeping your costs down is a growing burden on manufacturers and supply chains, argues Kallik’s David Bennett
The growing appetite and opportunity for increased personalisation of medical treatment plans, devices and medicines is clear, promising to improve the efficacy and safety of life sciences products and services for patients. Yet this in turn places a growing burden on manufacturers and supply chains to manage multiplying stock-keeping units, as the number of variants of each product increases. Batches are becoming smaller and the number of packaging and labelling variants are soaring to meet the growing demand of personalisation. Managing this logistical complexity reliably, efficiently and consistently across markets and for all target…
The growing appetite and opportunity for increased personalisation of medical treatment plans, devices and medicines is clear, promising to improve the efficacy and safety of life sciences products and services for patients. Yet this in turn places a growing burden on manufacturers and supply chains to manage multiplying stock-keeping units, as the number of variants of each product increases. Batches are becoming smaller and the number of packaging and labelling variants are soaring to meet the growing demand of personalisation. Managing this logistical complexity reliably, efficiently and consistently across markets and for all target…
The COVID-19 pandemic has created an unprecedented challenge for pharmaceutical companies thrusting them into an unforeseen scenario where they must manage competing priorities for the protection of both their patients and their personnel.
The COVID-19 pandemic has created an unprecedented challenge for pharmaceutical companies thrusting them into an unforeseen scenario where they must manage competing priorities for the protection of both their patients and their personnel. As companies strive to manage and maintain their supply chains to minimise patient impact, they are required to restrict travel, follow government directives limiting social contact and ensure they prevent exposure of their personnel to infection with COVID-19. In the pharmaceutical industry there is an emphasis on robu…
The COVID-19 pandemic has created an unprecedented challenge for pharmaceutical companies thrusting them into an unforeseen scenario where they must manage competing priorities for the protection of both their patients and their personnel. As companies strive to manage and maintain their supply chains to minimise patient impact, they are required to restrict travel, follow government directives limiting social contact and ensure they prevent exposure of their personnel to infection with COVID-19. In the pharmaceutical industry there is an emphasis on robu…
The study, from Kinds College London, looked at responses from more than 400,000 people reporting suspected COVID-19 symptoms via an app.
A new study gives weight to emerging evidence that a loss of smell and taste is a common symptom of COVID-19 – according to University of East Anglia (UEA) smell expert Prof Carl Philpott. The study, from Kinds College London, looked at responses from more than 400,000 people reporting suspected COVID-19 symptoms via an app. It found that 59 per cent of 579 people who said they had tested positive for the virus reported a loss of smell or taste. But loss of smell and taste are also signs of other infections, such as the common cold. Prof Philpott, from UEA’s Norwich Medical School, said: "Coronaviruses have been associated with what we refer to as post-vi…
A new study gives weight to emerging evidence that a loss of smell and taste is a common symptom of COVID-19 – according to University of East Anglia (UEA) smell expert Prof Carl Philpott. The study, from Kinds College London, looked at responses from more than 400,000 people reporting suspected COVID-19 symptoms via an app. It found that 59 per cent of 579 people who said they had tested positive for the virus reported a loss of smell or taste. But loss of smell and taste are also signs of other infections, such as the common cold. Prof Philpott, from UEA’s Norwich Medical School, said: "Coronaviruses have been associated with what we refer to as post-vi…
As readers of this article who have most likely worked in the regulatory, research, development or manufacturing area for drug products, I’m sure you have been drawn to read the many scientific and technical advances that are being fast tracked at present in response to the current global emergency.
As readers of this article who have most likely worked in the regulatory, research, development or manufacturing area for drug products, I’m sure you have been drawn to read the many scientific and technical advances that are being fast tracked at present in response to the current global emergency. For those of us in an industry who comprehend the lengthy and expensive process of drug discovery, testing and trials, the speed and urgency at which our industry is moving to develop an effective v…
As readers of this article who have most likely worked in the regulatory, research, development or manufacturing area for drug products, I’m sure you have been drawn to read the many scientific and technical advances that are being fast tracked at present in response to the current global emergency. For those of us in an industry who comprehend the lengthy and expensive process of drug discovery, testing and trials, the speed and urgency at which our industry is moving to develop an effective v…
The pandemic that the world is now facing is causing a lot of confusion and fear among many, especially those of us who have a compromised immune system.
The pandemic that the world is now facing is causing a lot of confusion and fear among many, especially those of us who have a compromised immune system. I am very grateful to have lived 12 years since my diagnosis of pancreatic cancer and, as every year passes, that awful and frightening diagnosis feels ever more distant and as time goes on it is thought that when I eventually die, that it will be of something else. Will it be coronavirus? Well, I just don’t know. When it started It was the beginning of March that we had a team meeting at Pancreatic Cancer Action about the coronavirus and how we can protect our staff. As I had had my spl…
The pandemic that the world is now facing is causing a lot of confusion and fear among many, especially those of us who have a compromised immune system. I am very grateful to have lived 12 years since my diagnosis of pancreatic cancer and, as every year passes, that awful and frightening diagnosis feels ever more distant and as time goes on it is thought that when I eventually die, that it will be of something else. Will it be coronavirus? Well, I just don’t know. When it started It was the beginning of March that we had a team meeting at Pancreatic Cancer Action about the coronavirus and how we can protect our staff. As I had had my spl…
Set up in the UK in 1999 to create consistency across NHS treatment and care, the National Institute for Health and Clinical Excellence (or NICE) now has an international reputation for its guidance (including guidelines) on the management and treatment of illnesses.
An introduction to NICE Set up in the UK in 1999 to create consistency across NHS treatment and care, the National Institute for Health and Clinical Excellence (or NICE) now has an international reputation for its guidance (including guidelines) on the management and treatment of illnesses. Currently, NICE guidelines are prepared by specifically formed groups, which consider the product or treatment in question, taking into account the views of any interested parties and looking at cost as well as the medical efficacy of the…
An introduction to NICE Set up in the UK in 1999 to create consistency across NHS treatment and care, the National Institute for Health and Clinical Excellence (or NICE) now has an international reputation for its guidance (including guidelines) on the management and treatment of illnesses. Currently, NICE guidelines are prepared by specifically formed groups, which consider the product or treatment in question, taking into account the views of any interested parties and looking at cost as well as the medical efficacy of the…
At PharmiWeb, we’re taking the government’s recommendations very seriously, and are implementing changes where required and providing clear guidelines to our team.
As we’re all aware by now, the coronavirus outbreak Is having a significant impact on our daily lives - and it seems it will for some time to come.At PharmiWeb, we’re taking the government’s recommendations very seriously, and are implementing changes where required and providing clear guidelines to our team.Whilst remaining committed to providing you with the best possible service.As a mainly on-line company, our team is already set up to work flexibly from home (many of us already do), and our servers along with the majority of our support services (such as our email and phone systems) are cloud-based. This means it will be bus…
As we’re all aware by now, the coronavirus outbreak Is having a significant impact on our daily lives - and it seems it will for some time to come.At PharmiWeb, we’re taking the government’s recommendations very seriously, and are implementing changes where required and providing clear guidelines to our team.Whilst remaining committed to providing you with the best possible service.As a mainly on-line company, our team is already set up to work flexibly from home (many of us already do), and our servers along with the majority of our support services (such as our email and phone systems) are cloud-based. This means it will be bus…
