Medical comms - Articles
09-Jan-2013
Get the latest PharmiWeb iPhone App, and get the jobs while you're on the move.
You can now search for jobs, and email them to yourself with a couple of clicks. Alternatively, if you you login as a registered user, you can apply directly to the job using the CV stored in your account, and you can even modify your cover letter directly from the app before you send it.To download the app, simply go to Apple's app store and search for PharmiWeb.
You can now search for jobs, and email them to yourself with a couple of clicks. Alternatively, if you you login as a registered user, you can apply directly to the job using the CV stored in your account, and you can even modify your cover letter directly from the app before you send it.To download the app, simply go to Apple's app store and search for PharmiWeb.
As more and more sponsors engage contract research organizations (CROs) at the discovery phase and the complexity of outsourced studies rises, the ability to manage the relationships between site, CRO and sponsor becomes more and more vital.
As more and more sponsors engage contract research organizations (CROs) at the discovery phase and the complexity of outsourced studies rises, the ability to manage the relationships between site, CRO and sponsor becomes more and more vital. The most obvious way to nurture that relationship is to establish clear communications guidelines from the start—well before study startup.For example, effective collaboration between site and CRO can be jeopardized if the CRO challenges site practices instead of bringing queries or discrepancies to the sponsor fir…
As more and more sponsors engage contract research organizations (CROs) at the discovery phase and the complexity of outsourced studies rises, the ability to manage the relationships between site, CRO and sponsor becomes more and more vital. The most obvious way to nurture that relationship is to establish clear communications guidelines from the start—well before study startup.For example, effective collaboration between site and CRO can be jeopardized if the CRO challenges site practices instead of bringing queries or discrepancies to the sponsor fir…
Do you ever wish you had the quickly-evolving terminology of our industry at your fingertips?
Do you ever wish you had the quickly-evolving terminology of our industry at your fingertips? This easy to use "back-pocket" reference guide helps you to navigate more than 900 key terms and over 500 acronyms that are commonly used in clinical research. This all-new edition has been expanded and includes terms and acronyms for:Clinical ResearchPre-Clinical ResearchRegulatory SubmissionsMedical DevicesData ManagementStatisticsPricing and ReimbursementThe US, EU, and ICH RegionsThe 2009 edition is almost twice as long as the previous edition, and includes the terminology you need to know in today's global clinical and regulatory environment. Glossary & Acronyms is an excellent companion to our CF…
Do you ever wish you had the quickly-evolving terminology of our industry at your fingertips? This easy to use "back-pocket" reference guide helps you to navigate more than 900 key terms and over 500 acronyms that are commonly used in clinical research. This all-new edition has been expanded and includes terms and acronyms for:Clinical ResearchPre-Clinical ResearchRegulatory SubmissionsMedical DevicesData ManagementStatisticsPricing and ReimbursementThe US, EU, and ICH RegionsThe 2009 edition is almost twice as long as the previous edition, and includes the terminology you need to know in today's global clinical and regulatory environment. Glossary & Acronyms is an excellent companion to our CF…
08-Jan-2013
The last year has been a turbulent one in regulatory terms, with a raft of legislative changes as patient safety and global standardisation have risen up the agenda. Joel Finkle & Gillian King of CSC assess the changes.
In the US, the FDA is pursuing an electronic submissions strategy fairly aggressively, though favouring phased migration. The goal is mandatory eCTD submission, driven by the Food and Drug Administration Safety and Innovation Act (FDASIA). This also includes the acceptance of electronic submissions for devices. Under the FDASIA, all New Drug Applications (NDAs) must be filed electronically by 2015; all Investigational New Drug Applications (INDs) by 2016.The FDA has also been developing guidance for Module 1 version 2, which enables the submission of promotional materials i…
In the US, the FDA is pursuing an electronic submissions strategy fairly aggressively, though favouring phased migration. The goal is mandatory eCTD submission, driven by the Food and Drug Administration Safety and Innovation Act (FDASIA). This also includes the acceptance of electronic submissions for devices. Under the FDASIA, all New Drug Applications (NDAs) must be filed electronically by 2015; all Investigational New Drug Applications (INDs) by 2016.The FDA has also been developing guidance for Module 1 version 2, which enables the submission of promotional materials i…
Principles and Practice of Clinical Research. Edition No. 3 by researchandmarkets.com
The third edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, cop…
The third edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, cop…
In this article, Emma Collins describes a trend that most Pharmiweb readers should be aware of - the use of social media and other online tools for recruitment. Job seekers today face a much different world than they did even five years ago, and web-based strategies are one of the most important new developments.
Emma Collins recently edited this year's top academic institutions offering MBA degrees online, and has made a career out of giving advice to professional students. Feel free to forward this article to anyone who might be able to benefit from a new job searching perspective. Most of today’s recent college and masters degree graduates are highly connected online. What many may not realize is that social networks and web presences can be used for much more than simply making fri…
Emma Collins recently edited this year's top academic institutions offering MBA degrees online, and has made a career out of giving advice to professional students. Feel free to forward this article to anyone who might be able to benefit from a new job searching perspective. Most of today’s recent college and masters degree graduates are highly connected online. What many may not realize is that social networks and web presences can be used for much more than simply making fri…
Clinical Research Updates bring together guidance on everything to do with clinical trials, from pharmacokinetics and study design, to recruitment, monitoring, protection of subjects, statistics, budgeting ...
Clinical Research Updates bring together guidance on everything to do with clinical trials, from pharmacokinetics and study design, to recruitment, monitoring, protection of subjects, statistics, budgeting ... all the compliance areas you need to conduct clinical trials that will conform to the regulations.Written by some of the finest experts working in the clinical trials field, Clinical Research Updates translate regulations and best practices into real-world guidance. Both new and experienced trial managers will find the information they need to set up and run every phase of a cli…
Clinical Research Updates bring together guidance on everything to do with clinical trials, from pharmacokinetics and study design, to recruitment, monitoring, protection of subjects, statistics, budgeting ... all the compliance areas you need to conduct clinical trials that will conform to the regulations.Written by some of the finest experts working in the clinical trials field, Clinical Research Updates translate regulations and best practices into real-world guidance. Both new and experienced trial managers will find the information they need to set up and run every phase of a cli…
Clinical Research Updates bring together guidance on everything to do with clinical trials, from pharmacokinetics and study design, to recruitment, monitoring, protection of subjects, statistics, budgeting ...
Clinical Research Updates bring together guidance on everything to do with clinical trials, from pharmacokinetics and study design, to recruitment, monitoring, protection of subjects, statistics, budgeting ... all the compliance areas you need to conduct clinical trials that will conform to the regulations.Written by some of the finest experts working in the clinical trials field, Clinical Research Updates translate regulations and best practices into real-world guidance. Both new and experienced trial managers will find the information they need to set up and run every phase of a cli…
Clinical Research Updates bring together guidance on everything to do with clinical trials, from pharmacokinetics and study design, to recruitment, monitoring, protection of subjects, statistics, budgeting ... all the compliance areas you need to conduct clinical trials that will conform to the regulations.Written by some of the finest experts working in the clinical trials field, Clinical Research Updates translate regulations and best practices into real-world guidance. Both new and experienced trial managers will find the information they need to set up and run every phase of a cli…
18-Dec-2012
The secret behind successful digital marketing strategies within the pharmaceutical and healthcare sector, is the underpinning of skillfully managed systems, processes and relationships.
The secret behind successful digital marketing strategies within the pharmaceutical and healthcare sector, is the underpinning of skillfully managed systems, processes and relationships.Achieving digital marketing buy-in will send a powerful and positive message to the whole organisation saying ‘we are doing this and it is really going to happen!’ Once the buy-in is achieved it is crucial that this is also supported by senior management to really optimise the chances of an initiative’s longer term success.The third whitepaper in the series is now available to download and looks at the exciting way digital…
The secret behind successful digital marketing strategies within the pharmaceutical and healthcare sector, is the underpinning of skillfully managed systems, processes and relationships.Achieving digital marketing buy-in will send a powerful and positive message to the whole organisation saying ‘we are doing this and it is really going to happen!’ Once the buy-in is achieved it is crucial that this is also supported by senior management to really optimise the chances of an initiative’s longer term success.The third whitepaper in the series is now available to download and looks at the exciting way digital…
The European Court of Human Rights (ECtHR) has held that the United Kingdom breached the European Convention on Human Rights (ECHR) by failing to take “reasonable and appropriate” measures to protect employees, including those with less than one year's service, from being dismissed on grounds of their political opinion or affiliation – even if the association’s views “offend shock or disturb”.
The European Court of Human Rights (ECtHR) has held that the United Kingdom breached the European Convention on Human Rights (ECHR) by failing to take "reasonable and appropriate" measures to protect employees, including those with less than one year's service, from being dismissed on grounds of their political opinion or affiliation – even if the association’s views "offend shock or disturb". (RED…
The European Court of Human Rights (ECtHR) has held that the United Kingdom breached the European Convention on Human Rights (ECHR) by failing to take "reasonable and appropriate" measures to protect employees, including those with less than one year's service, from being dismissed on grounds of their political opinion or affiliation – even if the association’s views "offend shock or disturb". (RED…
07-Dec-2012
The new level of maturity that has been reached by digital technologies has been a vital way for pharmaceutical companies to engage with their customers.
The new level of maturity that has been reached by digital technologies has been a vital way for pharmaceutical companies to engage with their customers.Combining the power and reliability of devices and platforms with the customer’s need to move towards using digital interaction, it is crucial that companies embrace the use of great technology to drive strong customer relationships and forge alignment with strategic business objectives.The second whitepaper in the series is now available to download and looks at the exciting way digital technology has evolved:'From shiny new toy' to business tool: the digital devices and technologies set…
The new level of maturity that has been reached by digital technologies has been a vital way for pharmaceutical companies to engage with their customers.Combining the power and reliability of devices and platforms with the customer’s need to move towards using digital interaction, it is crucial that companies embrace the use of great technology to drive strong customer relationships and forge alignment with strategic business objectives.The second whitepaper in the series is now available to download and looks at the exciting way digital technology has evolved:'From shiny new toy' to business tool: the digital devices and technologies set…
The International Directory of Pharmaceutical Companies 2012 is the most comprehensive and accurate Directory of companies and executives in the pharmaceutical industry that have ever been published. It contains more than 20,000 pharmaceutical companies in over 200 countries and 30,000 executives working in the industry around the world.
The International Directory of Pharmaceutical Companies 2012 is the most comprehensive and accurate Directory of companies and executives in the pharmaceutical industry that have ever been published. It contains more than 20,000 pharmaceutical companies in over 200 countries and 30,000 executives working in the industry around the world. This powerful Directory is your connection to key decision-makers in the pharmaceutical industry in Europe, North and So…
The International Directory of Pharmaceutical Companies 2012 is the most comprehensive and accurate Directory of companies and executives in the pharmaceutical industry that have ever been published. It contains more than 20,000 pharmaceutical companies in over 200 countries and 30,000 executives working in the industry around the world. This powerful Directory is your connection to key decision-makers in the pharmaceutical industry in Europe, North and So…
12-Nov-2012
A growing demand for drugs and the potential for blockbuster returns make the pharmaceutical sector a rare bright spot in the current economic gloom.
A growing demand for drugs and the potential for blockbuster returns make the pharmaceutical sector a rare bright spot in the current economic gloom. But financial pressures and the looming patent cliff are having a potentially devastating impact on pharmaceutical R&D. Whilst pharma companies must adapt with the times, it is vital that the need to innovate is not overshadowed by the pressure to cut costs.These are challenging times for the once “recession-proof” pharmaceutical and biotech industries. The sector has been left exposed by the fast-approaching patent cliff and its devastating impact on revenues as some of the biggest earning…
A growing demand for drugs and the potential for blockbuster returns make the pharmaceutical sector a rare bright spot in the current economic gloom. But financial pressures and the looming patent cliff are having a potentially devastating impact on pharmaceutical R&D. Whilst pharma companies must adapt with the times, it is vital that the need to innovate is not overshadowed by the pressure to cut costs.These are challenging times for the once “recession-proof” pharmaceutical and biotech industries. The sector has been left exposed by the fast-approaching patent cliff and its devastating impact on revenues as some of the biggest earning…
It is easy to see Intellectual Property (IP) and competition law as opposing forces in a case of patent versus patient.
It is easy to see Intellectual Property (IP) and competition law as opposing forces in a case of patent versus patient. But in reality, both are simply different means of boosting innovation and improving medical treatment. IP rights allow companies to recoup sufficient income to reinvest in the development of new drugs, whilst competition puts pressure on companies to innovate in order to keep stride with market rivals. If the right balance is struck, both work together to drive the R&D necessary to find new drugs and treatments.IP is vital to the patent-rich pharmaceutical sector. The patent cliff is having a devastating impact on revenues as some of the biggest ear…
It is easy to see Intellectual Property (IP) and competition law as opposing forces in a case of patent versus patient. But in reality, both are simply different means of boosting innovation and improving medical treatment. IP rights allow companies to recoup sufficient income to reinvest in the development of new drugs, whilst competition puts pressure on companies to innovate in order to keep stride with market rivals. If the right balance is struck, both work together to drive the R&D necessary to find new drugs and treatments.IP is vital to the patent-rich pharmaceutical sector. The patent cliff is having a devastating impact on revenues as some of the biggest ear…
05-Nov-2012
Many employers may think that once an employee leaves their employment, they are not liable for any further acts of discrimination; however, think again.
Many employers may think that once an employee leaves their employment, they are not liable for any further acts of discrimination; however, think again. If an employee (or ex-employee) brings a claim or raises a grievance alleging discrimination, and their ex-employer treats them less favourably as a result, they could face a separate claim for “victimisation”. The same is also true where an employer treats a witness or a “companion” employee less favourably. The issue of victimisation post-employment was highlighted in the recent case of Taiwo v Olaigbe and others where the employment tribunal was asked to consider whether post-empl…
Many employers may think that once an employee leaves their employment, they are not liable for any further acts of discrimination; however, think again. If an employee (or ex-employee) brings a claim or raises a grievance alleging discrimination, and their ex-employer treats them less favourably as a result, they could face a separate claim for “victimisation”. The same is also true where an employer treats a witness or a “companion” employee less favourably. The issue of victimisation post-employment was highlighted in the recent case of Taiwo v Olaigbe and others where the employment tribunal was asked to consider whether post-empl…
Plans were announced by the Government (14 September 2012) to give employers more “flexibility” and “reduce employment law red tape”.
Plans were announced by the Government (14 September 2012) to give employers more “flexibility” and “reduce employment law red tape”. Below, we give details of the announcement:Introduction of “settlement agreements” and new template documents – the aim here is to allow parties to settle disputes earlier without the need to take a claim to an employment tribunal. It is proposed to simplify compromise agreements which are seen as being too legalistic However, just how far they can be stripped back into a simple form agreement which does not leave the employer exposed to future claims, will have to be seen. As part of this exercise, ACAS will also be prod…
Plans were announced by the Government (14 September 2012) to give employers more “flexibility” and “reduce employment law red tape”. Below, we give details of the announcement:Introduction of “settlement agreements” and new template documents – the aim here is to allow parties to settle disputes earlier without the need to take a claim to an employment tribunal. It is proposed to simplify compromise agreements which are seen as being too legalistic However, just how far they can be stripped back into a simple form agreement which does not leave the employer exposed to future claims, will have to be seen. As part of this exercise, ACAS will also be prod…
PharmiWeb Solutions’ second Digital Breakfast opens new opportunities for Harnessing Big Data in Pharma
Delegates discovered novel strategic approaches to harnessing Big Data and the key challenges facing senior executives at the second Digital Breakfast hosted by PharmiWeb Solutions, specialists in delivering and managing digital solutions for the pharmaceutical industry.The event provided a morning of inspiration and insight from industry-leading experts, including Duncan Ross, Director of Data Science, Teradata; John Burn-Murdoch, Data Journalist, The Guardian; Beat Bühlmann, Industry Leader Health Care UK, Google; Mike Plimsoll, Industry Marketing Leader, Adobe and PharmiWeb's own CEO, Paul Hartigan.Watch highlights from the PharmiWeb Digital Breakfast!Follow us on Twitter @PharmiWeb, a…
Delegates discovered novel strategic approaches to harnessing Big Data and the key challenges facing senior executives at the second Digital Breakfast hosted by PharmiWeb Solutions, specialists in delivering and managing digital solutions for the pharmaceutical industry.The event provided a morning of inspiration and insight from industry-leading experts, including Duncan Ross, Director of Data Science, Teradata; John Burn-Murdoch, Data Journalist, The Guardian; Beat Bühlmann, Industry Leader Health Care UK, Google; Mike Plimsoll, Industry Marketing Leader, Adobe and PharmiWeb's own CEO, Paul Hartigan.Watch highlights from the PharmiWeb Digital Breakfast!Follow us on Twitter @PharmiWeb, a…
Next time you pop a pill from a packet, spare a thought about how it got to you.
Next time you pop a pill from a packet, spare a thought about how it got to you.The process for manufacturing, packaging and delivering pharmaceuticals to pharmacies, surgeries and hospitals around the world is a complex one. It involves integrating information from hundreds of different organisations, each with a varying role in the overall process. To make things run smoothly and efficiently, each of these organisations needs the ability to easily share data with the pharmaceutical company making the product.This is particularly true for the Orion Corporation, a globally operating Finnish company developing pharmaceuticals and diagnostic tests − a builder of well-being. Orion (based in Espoo) develops, man…
Next time you pop a pill from a packet, spare a thought about how it got to you.The process for manufacturing, packaging and delivering pharmaceuticals to pharmacies, surgeries and hospitals around the world is a complex one. It involves integrating information from hundreds of different organisations, each with a varying role in the overall process. To make things run smoothly and efficiently, each of these organisations needs the ability to easily share data with the pharmaceutical company making the product.This is particularly true for the Orion Corporation, a globally operating Finnish company developing pharmaceuticals and diagnostic tests − a builder of well-being. Orion (based in Espoo) develops, man…
Despite many pledges from Government to change the employment law landscape, this October’s legislative programme is a relatively quiet one for employment lawyers and employers.
Despite many pledges from Government to change the employment law landscape, this October’s legislative programme is a relatively quiet one for employment lawyers and employers. Many proposed statutory changes are still either currently before Parliament or still in the pipeline. However, as we look forward to October 2012 and beyond, there are still some changes employers should be aware of.AUTOMATIC PENSIONS ENROLMENT – 1 OCTOBER 2012From 1 October 2012, employers will be required to “auto-enrol” eligible employees not currently participating in a workplace pension scheme into either a qualifying pension scheme…
Despite many pledges from Government to change the employment law landscape, this October’s legislative programme is a relatively quiet one for employment lawyers and employers. Many proposed statutory changes are still either currently before Parliament or still in the pipeline. However, as we look forward to October 2012 and beyond, there are still some changes employers should be aware of.AUTOMATIC PENSIONS ENROLMENT – 1 OCTOBER 2012From 1 October 2012, employers will be required to “auto-enrol” eligible employees not currently participating in a workplace pension scheme into either a qualifying pension scheme…
24-Sep-2012
“Everytime you see a child with a helium balloon, imagine somebody not being able to have an MRI scan that they desperately needed,” says Tom Welton,
Professor of Sustainable Chemistry at Imperial College.
“Everytime you see a child with a helium balloon, imagine somebody not being able to have an MRI scan that they desperately needed,” says Tom Welton, Professor of Sustainable Chemistry at Imperial College. As the professor warns that the helium shortage may soon impact the pharmaceutical industry, contract research organisation Melbourn Scientific, based in Melbourn Herts, is already responding.“Helium is truly a finite resource”, Prof. Welton continues. “With increasing demand from places like China, supply cannot keep up. We have already been warned that availability is patchy and we…
“Everytime you see a child with a helium balloon, imagine somebody not being able to have an MRI scan that they desperately needed,” says Tom Welton, Professor of Sustainable Chemistry at Imperial College. As the professor warns that the helium shortage may soon impact the pharmaceutical industry, contract research organisation Melbourn Scientific, based in Melbourn Herts, is already responding.“Helium is truly a finite resource”, Prof. Welton continues. “With increasing demand from places like China, supply cannot keep up. We have already been warned that availability is patchy and we…
