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PPD takes pharmacovigilance to Bulgaria

In most industries, companies regard the issue of successfully getting products
available on a wide scale as the biggest challenge facing them. However, this is
not the case in the world of pharmaceuticals, as the projects of drug development
firms do not necessarily end when their latest items hit the shelves.

This is generally where pharmacovigilance – the ongoing assessment of drugs for
evidence of potential new hazards to patients – tends to come in. As such
services play a key role in ensuring medicines remain suitable for consumers
across the globe, many companies that specialise in the area have sprung up in
recent years. In addition, a number of others have enjoyed major growth.
One firm that falls into the latter category is PPD, a leading global contract
research organisation with around 25 years of experience in drug discovery,
development and lifecycle management services. Notably, the organisation has
much experience in the world of pharmacovigilance and is looking to take the
concept into new territories across the globe.

The company recently opened a new centre in Sofia, Bulgaria, where its staff will
provide medical information call centre support and scientists will also be on hand
to work on pharmacovigilance projects.

More specifically, the experts will consider a number of issues including adverse
event capture, safety case processing and reporting, and periodic writing
services. As the area is home to several medical and pharmacy schools, the
centre is likely to be able to recruit highly-trained healthcare professionals with
extensive language capabilities locally. Nurses, physicians and pharmacists will be
employed on-site, as PPD aims to have more than 200 professionals working
there within the next 12 months.

Dr Christine Dingivan, chief medical officer at PPD, suggested the decision to
establish the base in Bulgaria was driven by rising demand for pharmacovigilance
across the globe. "Expanding our safety and medical communications operations
in Europe strengthens our ability to bring high-quality global healthcare expertise
to provide these services in an efficient, cost-effective and regulatory compliant
manner," she explained.

"There is strong demand for both pre and post-approval safety services, and we
have an experienced management team on the ground in Bulgaria to oversee our
operations and to create customised programs that meet client needs."
The new site in Sofia will be PPD's third European hub, as it already runs
operations from a facility in Athlone, Ireland, as well as contact centre services in
the Swedish capital Stockholm.

While the move is set to bring major benefits to the company, particularly
through expanding the range of the company's pharmacovigilance services, the
country of Bulgaria is also likely to prosper.

James Warlick, the US ambassador to Bulgaria, said PPD was making "a
significant investment" in an "important technical field" which could play a major
part in the country's future. "Bulgaria has a noteworthy and rich history of
innovation and technology, and both PPD and the people of Bulgaria can benefit
from this venture," he explained.

"The US Embassy looks forward to further strengthening our relationship with
PPD as it expands in this region."
The growth that PPD is enjoying is not only evidence of the firm's own good
fortunes, but also the increasing demand that is emerging for pharmacovigilance
services across the globe. In a way its importance should not be surprising,
particularly as drug developers could put their reputations – and potentially the
lives of patients – in jeopardy by failing to take the concept into account.

As drug safety remains such a fundamental aspect of the pharmaceutical
industry, it is likely that more firms will experience similar growth to PPD – which
in turn will make pharmacoviligance a truly global concern.

DirectNews
11/05/10

Found this interesting?
You may like to also have a look at Adverse Event Reporting - Online Training
Course

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Ppd takes pharmacovigilance to bulgaria

  • 1. PPD takes pharmacovigilance to Bulgaria In most industries, companies regard the issue of successfully getting products available on a wide scale as the biggest challenge facing them. However, this is not the case in the world of pharmaceuticals, as the projects of drug development firms do not necessarily end when their latest items hit the shelves. This is generally where pharmacovigilance – the ongoing assessment of drugs for evidence of potential new hazards to patients – tends to come in. As such services play a key role in ensuring medicines remain suitable for consumers across the globe, many companies that specialise in the area have sprung up in recent years. In addition, a number of others have enjoyed major growth. One firm that falls into the latter category is PPD, a leading global contract research organisation with around 25 years of experience in drug discovery, development and lifecycle management services. Notably, the organisation has much experience in the world of pharmacovigilance and is looking to take the concept into new territories across the globe. The company recently opened a new centre in Sofia, Bulgaria, where its staff will provide medical information call centre support and scientists will also be on hand to work on pharmacovigilance projects. More specifically, the experts will consider a number of issues including adverse event capture, safety case processing and reporting, and periodic writing services. As the area is home to several medical and pharmacy schools, the centre is likely to be able to recruit highly-trained healthcare professionals with extensive language capabilities locally. Nurses, physicians and pharmacists will be employed on-site, as PPD aims to have more than 200 professionals working there within the next 12 months. Dr Christine Dingivan, chief medical officer at PPD, suggested the decision to establish the base in Bulgaria was driven by rising demand for pharmacovigilance across the globe. "Expanding our safety and medical communications operations in Europe strengthens our ability to bring high-quality global healthcare expertise to provide these services in an efficient, cost-effective and regulatory compliant manner," she explained. "There is strong demand for both pre and post-approval safety services, and we have an experienced management team on the ground in Bulgaria to oversee our operations and to create customised programs that meet client needs." The new site in Sofia will be PPD's third European hub, as it already runs operations from a facility in Athlone, Ireland, as well as contact centre services in the Swedish capital Stockholm. While the move is set to bring major benefits to the company, particularly through expanding the range of the company's pharmacovigilance services, the country of Bulgaria is also likely to prosper. James Warlick, the US ambassador to Bulgaria, said PPD was making "a significant investment" in an "important technical field" which could play a major part in the country's future. "Bulgaria has a noteworthy and rich history of innovation and technology, and both PPD and the people of Bulgaria can benefit from this venture," he explained. "The US Embassy looks forward to further strengthening our relationship with PPD as it expands in this region." The growth that PPD is enjoying is not only evidence of the firm's own good
  • 2. fortunes, but also the increasing demand that is emerging for pharmacovigilance services across the globe. In a way its importance should not be surprising, particularly as drug developers could put their reputations – and potentially the lives of patients – in jeopardy by failing to take the concept into account. As drug safety remains such a fundamental aspect of the pharmaceutical industry, it is likely that more firms will experience similar growth to PPD – which in turn will make pharmacoviligance a truly global concern. DirectNews 11/05/10 Found this interesting? You may like to also have a look at Adverse Event Reporting - Online Training Course