Articles
15-Feb-2013
This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research.
This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.Click here for more details
This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.Click here for more details
13-Feb-2013
Recruiters frequently asked questions
Below is a list of questions specific to Recruiters on Pharmiweb.com. To reveal the answer to each question, click onto the question.Can’t find an answer for a question?Contact the Pharmiweb team at help@pharmiweb.com and submit your question. The eNewsletter goes out once a week, and we can offer you the following Promotional Opportunities: 1. Top Banner. Animated gif (468x60) linked to a URL of your choice. 2. Feature. About 100 words of "Editorial". This can include a link and an optional Photo (gif or jpg, 100x100 pixels), plus a link to a URL of your choice. 3. Featured Job. This adds your job title, Benefits and…
Below is a list of questions specific to Recruiters on Pharmiweb.com. To reveal the answer to each question, click onto the question.Can’t find an answer for a question?Contact the Pharmiweb team at help@pharmiweb.com and submit your question. The eNewsletter goes out once a week, and we can offer you the following Promotional Opportunities: 1. Top Banner. Animated gif (468x60) linked to a URL of your choice. 2. Feature. About 100 words of "Editorial". This can include a link and an optional Photo (gif or jpg, 100x100 pixels), plus a link to a URL of your choice. 3. Featured Job. This adds your job title, Benefits and…
13-Feb-2013
Frequently Asked Question for Event Posting
Below is a list of questions specific to Events on Pharmiweb.com. To reveal the answer to each question, click onto the question.Can’t find an answer for a question?Contact the Pharmiweb team at help@pharmiweb.com and submit your question. You can add your event details for nothing here. Of course we approve them before they go live, and they need to be appropriate to the pharmaceutical industry. Unfortunately you can't right now. But if you email help@pharmiweb.com we can make any changes for you. If the Changes are major, it may be easier to post it again then email help@pharmiweb.com to tell us to delete the old one. You will need to drop an email to editor@pharmiweb.com with the details of the event and your required change. This will normall…
Below is a list of questions specific to Events on Pharmiweb.com. To reveal the answer to each question, click onto the question.Can’t find an answer for a question?Contact the Pharmiweb team at help@pharmiweb.com and submit your question. You can add your event details for nothing here. Of course we approve them before they go live, and they need to be appropriate to the pharmaceutical industry. Unfortunately you can't right now. But if you email help@pharmiweb.com we can make any changes for you. If the Changes are major, it may be easier to post it again then email help@pharmiweb.com to tell us to delete the old one. You will need to drop an email to editor@pharmiweb.com with the details of the event and your required change. This will normall…
13-Feb-2013
Frequently asked questions about Press Releases
Below is a list of questions specific to Press Releases on Pharmiweb.com. To reveal the answer to each question, click onto the question.Can’t find an answer for a question?Contact the Pharmiweb team at help@pharmiweb.comand submit your question.Once its submitted, we get a notification and check it out and approve it before it goes live. Its worth noting that our press releases do get picked up by a number of newsfeed services such as Moreover, so entries here can quite quite substantial exposure. ADD PRESS RELEASE HEREUnfortunately at the moment, you can't! so just drop your amendments on an email to help@pharmiweb.com and we will make the changes for you.Normally, press releases are approved within 24 hours if posted during the week. We do…
Below is a list of questions specific to Press Releases on Pharmiweb.com. To reveal the answer to each question, click onto the question.Can’t find an answer for a question?Contact the Pharmiweb team at help@pharmiweb.comand submit your question.Once its submitted, we get a notification and check it out and approve it before it goes live. Its worth noting that our press releases do get picked up by a number of newsfeed services such as Moreover, so entries here can quite quite substantial exposure. ADD PRESS RELEASE HEREUnfortunately at the moment, you can't! so just drop your amendments on an email to help@pharmiweb.com and we will make the changes for you.Normally, press releases are approved within 24 hours if posted during the week. We do…
13-Feb-2013
Candidate frequently asked questions
Below is a list of questions specific to posting events on Pharmiweb.com. To reveal the answer to each question, click onto the question.Can’t find an answer for a question?Contact the Pharmiweb team at help@pharmiweb.com and submit your question.Yes you can! If you search and save your job search (from the search results page - using the "send me jobs like this everyday") - your daily email has an RSS feed link too. Simply subscribe to this on your favourite RSS reader.There is currently no way to see a list the jobs you have applied for. However, for each application, you will receive an email confirmation from PharmiWeb.com. We are currently working on a new feature that will allow this.Each job alert email has a link at the bottom of to cancel…
Below is a list of questions specific to posting events on Pharmiweb.com. To reveal the answer to each question, click onto the question.Can’t find an answer for a question?Contact the Pharmiweb team at help@pharmiweb.com and submit your question.Yes you can! If you search and save your job search (from the search results page - using the "send me jobs like this everyday") - your daily email has an RSS feed link too. Simply subscribe to this on your favourite RSS reader.There is currently no way to see a list the jobs you have applied for. However, for each application, you will receive an email confirmation from PharmiWeb.com. We are currently working on a new feature that will allow this.Each job alert email has a link at the bottom of to cancel…
Five years ago, recruiters faced an enormous challenge when trying to attract candidates for senior level positions within generics pharmaceutical companies – nobody wanted to work for a generics business.
Five years ago, recruiters faced an enormous challenge when trying to attract candidates for senior level positions within generics pharmaceutical companies – nobody wanted to work for a generics business. Come 2013, we are seeing top level candidates from research based Pharma companies actively seek out a change to generics – what has changed and what is it like making the change into a generics company? Andy Stevens from Blue Pelican Pharma gives his views:“The rise of the attractiveness of a career in generics is a reflection of several factors. Firstly, the patent cliff suffered…
Five years ago, recruiters faced an enormous challenge when trying to attract candidates for senior level positions within generics pharmaceutical companies – nobody wanted to work for a generics business. Come 2013, we are seeing top level candidates from research based Pharma companies actively seek out a change to generics – what has changed and what is it like making the change into a generics company? Andy Stevens from Blue Pelican Pharma gives his views:“The rise of the attractiveness of a career in generics is a reflection of several factors. Firstly, the patent cliff suffered…
The year 2012 will soon pass into history, and what a year it was for biopharmaceuticals. In the United States, the Supreme Court affirmed the new healthcare reform law and exempted pharma companies from sales force overtime rules, the Food & Drug Administration (FDA) approved the first obesity drug in 13 years with Belviq, and billions of dollars changed hands as a result of government settlements.
The year 2012 will soon pass into history, and what a year it was for biopharmaceuticals. In the United States, the Supreme Court affirmed the new healthcare reform law and exempted pharma companies from sales force overtime rules, the Food & Drug Administration (FDA) approved the first obesity drug in 13 years with Belviq, and billions of dollars changed hands as a result of government sett…
The year 2012 will soon pass into history, and what a year it was for biopharmaceuticals. In the United States, the Supreme Court affirmed the new healthcare reform law and exempted pharma companies from sales force overtime rules, the Food & Drug Administration (FDA) approved the first obesity drug in 13 years with Belviq, and billions of dollars changed hands as a result of government sett…
17-Jan-2013
Few, if any, of those running life sciences companies in the UK or any of its peer economies in the West will look back on this point in history with great affection.
Few, if any, of those running life sciences companies in the UK or any of its peer economies in the West will look back on this point in history with great affection. The pharmaceuticals sector is under pressure all round – from increasing competition in the emerging world, from healthcare reforms and the effects of austerity and from the ongoing challenges of bringing drugs successfully to market. So, with so many problems already competing for managerial attention, it’s perhaps no surprise that a significant talent crisis looming in the background seems to have gone largely ignored.When headline writers keep telling us that…
Few, if any, of those running life sciences companies in the UK or any of its peer economies in the West will look back on this point in history with great affection. The pharmaceuticals sector is under pressure all round – from increasing competition in the emerging world, from healthcare reforms and the effects of austerity and from the ongoing challenges of bringing drugs successfully to market. So, with so many problems already competing for managerial attention, it’s perhaps no surprise that a significant talent crisis looming in the background seems to have gone largely ignored.When headline writers keep telling us that…
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…
25-Nov-2022
The Role of a Clinical Data Manager (CDM) is to ensure that all data from clinical trials is collected and recorded correctly, protecting the integrity of this data, and allowing accurate conclusions to be extracted from it. CDMs also develop and execute data testing and analysis plans, ensuring robust data quality and identifying new ways to improve existing processes.
The Role of a Clinical Data Manager (CDM) is to ensure that all data from clinical trials is collected and recorded correctly, protecting the integrity of this data, and allowing accurate conclusions to be extracted from it. CDMs also develop and execute data testing and analysis plans, ensuring robust data quality and identifying new ways to improve existing processes. What are the Main Responsibilities of a Clinical Data M…
The Role of a Clinical Data Manager (CDM) is to ensure that all data from clinical trials is collected and recorded correctly, protecting the integrity of this data, and allowing accurate conclusions to be extracted from it. CDMs also develop and execute data testing and analysis plans, ensuring robust data quality and identifying new ways to improve existing processes. What are the Main Responsibilities of a Clinical Data M…
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…
