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It will take time for any regulatory changes to be decided. PrimeVigilance has employees based in UK, Europe and the USA who will continue to operate all Pharmacovigilance and Medical Information services on a global basis. We are monitoring the evolving regulatory landscape and will update clients as required.
Please feel free to contact us at info@primevigilance.com if you have any questions.

PrimeVigilance announces further expansion and the opening of a US office in Boston, USA.
Guildford, UK – 27 June 2016: PrimeVigilance Limited one of Europe’s leading Pharmacovigilance and Medical Information (MI) service providers, is pleased to announce that it has established a US company office in Boston, USA.
The new office in Waltham just outside Boston, MA, opens in July 2016 and will become the US base for PrimeVigilance. This US base gives PrimeVigilance the presence needed to support its current North American clients and to further develop relationships with new clients looking for US services as well as for North American clients looking to enter the European and international markets.
Neil Clark PrimeVigilance CEO added: “We welcome our new employees in Boston and look forward to working with our existing clients and building new relationships. The North American market is a key growth area for PrimeVigilance and we are excited about the potential for our business.”
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About PrimeVigilance

PrimeVigilance is a dedicated pharmacovigilance and medical information service provider. Supporting pharma, biotech and generics companies in managing the global safety of their products from late stage development through full post-marketing activities. The pharmacovigilance  services offered by PrimeVigilance support essential regulatory and scientific elements  required to obtain and maintain a product license within Europe. This includes Qualified Persons,  a compliant PV System with robust Quality Management, consistent Adverse Event data capture, expedited reporting, literature screening, preparation of Periodic Safety Update Reports, signal detection and evaluation, benefit-risk assessment, Risk Management Planning, compliance auditing, support during crisis and ad hoc consulting assignments. PrimeVigilance also offers a multi-language Medical Information service. PrimeVigilance has grown organically since 2008 and now has approximately 200+ staff employed in its offices in Guildford UK, Zagreb, Croatia,  Belgrade, Serbia and Boston, USA as well as an international network of consultants. PrimeVigilance is currently providing services to clients based in Europe, North America, Australia and Asia / Pacific Rim, providing a global Pharmacovigilance and Medical Information system that currently covers more than 100 countries and over 150 medicinal products.
 For further information please visit www.primevigilance.com or alternatively please contact bd@primevigilance.com

 
PrimeVigilance is pleased to share the news that Dr. Elliot Brown, one of the founding Directors of PrimeVigilance, has been invited to become an honorary consultant to the WHO Uppsala Monitoring Centre and will join their Signal Review Panel. Dr Brown said: “I am delighted to have the opportunity of assisting the UMC in its important programme of activities supporting and promoting patient safety.”
The panel comprises clinical experts who review the results of the regular computerised screenings of ADR reports on all marketed products that have been submitted to the WHO Programme from national pharmacovigilance centres worldwide. The results of their work, consisting of a summary of available evidence, are circulated to national centres periodically in the ‘SIGNAL’ document and published in the WHO Pharmaceuticals Newsletter.
For more information please contact us at info@primevigilance.com or visit the UMC website at www.who-umc.org

 
Guildford, UK – 16 March 2015. PrimeVigilance, one of the world’s leading pharmacovigilance and medical information services providers is pleased to announce that Dr. Joerg Seebeck, Chief Medical Officer and Mr. Andy Harbrow, Global Medical Services Manager of PrimeVigilance, have been invited to speak at the DIA USA 2015 51st Annual Meeting taking place from 14^th to 18^th June, 2015. The event will be held at the Walter E. Washington Convention Center in Washington, DC.
Now in its 51st year, the DIA USA Annual Meeting is one of the largest multidisciplinary events that bring together Life Sciences professionals across all disciplines, with a common goal to foster innovation that will lead to the development of safe and effective medical products and therapies for patients.
Dr Joerg Seebeck will join the Clinical Safety and Pharmacovigilance Symposium panel on Wednesday 17th June at 10:30 am on the “Risk of Drug-Induced QT Interval Prolongation by Monoclonal Antibody Medicines: A Review of Data from an EU Database.”
Mr Andy Harbrow will join the Validation Symposium panel on Wednesday 17th June at 1:30 pm on the “Establishment of a new Medical Information Database: To Validate or Not to Validate – That Is the Question.”
Neil Clark, Director of PrimeVigilance said: “PrimeVigilance is committed to patient safety services and is at the forefront of developments in the Pharmacovigilance and Medical Information industry providing quality services and consultancy to our international clients. We are pleased that Dr Joerg Seebeck and Mr. Andy Harbrow have been invited to speak at one of the largest and prestigious events in the sector.”
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For further information, please contact:
Florence Denance Habek, Marketing and Business Development Manager
Tel: + 385 14628 503
E-mail: florence.denance.habek@primevigilance.com

About PrimeVigilance

The pharmacovigilance  services offered by PrimeVigilance support essential regulatory and scientific elements  required to obtain and maintain a product license within Europe. This includesQualified Persons,  a compliant PV System with robust Quality Management, consistent Adverse Event data capture, expedited reporting, literature screening, preparation of Periodic Safety Update Reports, signal detection and evaluation, benefit-risk assessment, Risk Management Planning, compliance auditing, support during crisis and ad hoc consulting assignments. PrimeVigilance also offers a multi-language Medical Information service. PrimeVigilance has grown organically since 2008 and now has approximately 140 staff employed in its main offices in Guildford UK, and Zagreb, Croatia, as well as an international network of consultants. PrimeVigilance is currently providing services across more than 100 countries.
For more information, visit: www.primevigilance.com

 
On the 28th of October in our Guildford office, PrimeVigilance was pleased to host the visit of  the HM Lord Lieutenant Dame Sarah Goad DCVO JP who came  with her Deputy and Cadet to present PrimeVigilance with the Queen’s Award for Enterprise 2014. The presentation was enjoyed by our UK Staff and representatives from our Croatian office and we were also happy to welcome the presence of Officials from the Croatian Embassy here in London.
This was all a very memorable and pleasant afternoon !

PrimeVigilance is pleased to share the news that Dr Joerg Seebeck has been invited to speak at the this year’s PIPA 9th Annual Conference on the 6th & 7th of  November 2014 at  Latimer Place, Chesham, UK. Joerg will be speaking twice on Friday the 7th of November, firstly on Risk-Based Approaches – What Does this Mean? and secondly on the Periodic Benefit-Risk Evaluation Reports (PBRERs). If you would wish to have a meeting during this event with Dr Joerg Seebeck do please contact us at   info@primevigilance.com
The Pharmaceutical Information and Pharmacovigilance Association (PIPA) exists to support and assist its members in the development of their professional skills and responsibilities. For individuals who are involved in the provision and management of information and those involved in the fulfillment of regulatory requirements relating to drug safety. The conference programme includes a range of presentations and workshops from expert speakers addressing topical matters of particular significance to MI and PV professionals.
For further information, please navigate to the PIPA Conference 2014 page.