NEWS: Medical Information Database: To validate or not to validate? That is the question posed by Andrew Harbrow

That is the question.” at the DIA 8th Medical Information and Communications Conference in London on 23-24 Sept 2014.
If you wish to receive a copy or have any questions please send us a request by writing us at contact PrimeVigilance.

NEWS: PrimeVigilance CMO Dr. Joerg Seebeck will be speaking at The Risk Management & Pharmacovigilance Summit


 
Dr Joerg Seebeck will be speaking at The Risk Management & Pharmacovigilance Summit, organised by the Allan Lloyds group, which will take place from September the 23rd to the 25th 2014 in Berlin, Germany. The conference will cover a range of topics including risk management plans and their implementation, benefit risk assessment process, pharmacovigilance system master file, post marketing surveillance, and drug safety risk management.
“Dr Seebeck will be speaking about Management of Emerging Safety Issues (ESI). The term “Emerging Safety Issue” has been introduced with the publication of the GVP modules. This presentation will explore the available regulatory guidance on ESI, help to interpret it, and discuss how MAHs in the EU should update their processes in order to adequately cover ESI-related requirements.”

NEWS: Dr Elliot Brown has published a chapter on Terminologies in Pharmacovigilance jointly with Daniel von Sydow in the Third Edition of Mann’s Pharmacovigilance

PrimeVigilance is pleased to share the news that Dr Elliot Brown, PrimeVigilance Board Director has published a chapter on Terminologies in Pharmacovigilance jointly with Daniel von Sydow, formerly of the WHO Uppsala Monitoring Centre. The article appears in the Third Edition of Mann’s Pharmacovigilance (Wiley Blackwell publishers, 2014), the definitive reference textbook for pharmacovigilance.
For further information please see the following link:
http://eu.wiley.com/WileyCDA/WileyTitle/productCd-0470671041.html

NEWS: PrimeVigilance Receives Queen’s Award for Enterprise Recognition of Substantial Growth and Commercial Success

Guildford, UK – 21 April 2014; PrimeVigilance Limited (PrimeVigilance), the specialist pharmacovigilance service provider, has been honoured with the Queen’s Award for Enterprise 2014 in the International Trade Category. PrimeVigilance has received the accolade – which is the highest official award for business success in the UK – in recognition of achieving substantial overseas earnings with growth and commercial success for the last six years.
PrimeVigilance is a leader in providing pharmacovigilance and medical information services for national and multi-national pharmaceutical companies worldwide. It has clients based in Europe, North America, Australia and Asia/Pacific Rim providing a global service that currently covers more than 100 countries and over 150 medicinal products.
PrimeVigilance has been awarded the Queen’s Award for International Trade for outstanding growth in overseas earnings of 173% over the last three years. In addition, the company has entered a number of new markets in this period including Australia, Germany, Spain, Switzerland and the Scandinavian countries.
Neil Clark, Chief Executive Officer of PrimeVigilance commented, “PrimeVigilance has grown substantially since it was founded six years ago and this award is testament to the high quality service we provide to our customers around the world. The Queen’s Award is a great honour not just for the company but for all of our individual employees internationally who have helped contribute to the company’s success. We look forward to building on our success and achieving further growth in the future.”
The Queen’s Awards for Enterprise is a prestigious awards programme for British businesses and organisations that excel at trade, innovation or sustainable development. The awards are made annually by HM The Queen, and are only given for the highest levels of excellence demonstrated in each category. They are judged to a demanding level and winners receive a number of benefits and worldwide recognition.
****

Note to Editors:

About PrimeVigilance Ltd
The pharmacovigilance (PV) services offered by PrimeVigilance cover all the regulatory and scientific elements of PV required to obtain and maintain product licences for medicines within Europe: Qualified Person, Risk Management Planning (RMP), and a compliant PV System with consistent Adverse Event data capture, robust Quality Management, expedited reporting, preparation of Periodic Safety Update Reports, literature screening, safety signal detection and evaluation, benefit-risk assessment, compliance auditing, support during crisis and various ad hoc assignments. PrimeVigilance also offers fully integrated international Medical Information services.
PrimeVigilance has grown organically since 2008 and now has over 100 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 further information please visit www.primevigilance.com or alternatively please contact:
 Neil Clark, CEO
Phone: +44 (0) 1225 731349
E-mail: neil.clark@primevigilance.com
 
Hume Brophy
Mary Clark, Supriya Mathur, Hollie Vile
Phone: + 44 203 440 5654
E-mail: healthcareteam@humebrophy.com

NEWS: Joerg Seebeck M.D. appointed Chief Medical Officer of PrimeVigilance

Guildford, UK – April 2014. PrimeVigilance, one of the world’s leading pharmacovigilance and medical information services companies has appointed Dr Joerg Seebeck as its Chief Medical Officer. He will head the PrimeVigilance medical group in their important work that includes reviewing reports of adverse reactions, signal detection, contributing to periodic safety update reports, risk management planning and provision of EU Qualified Person for Pharmacovigilance services. Joerg will also manage consultancy projects and take a leading role in overall client management.
Most recently, Joerg was the Head of Medical Services, Europe North for a large, global contract research organization and previously he worked for 6 years at BfArM, the German medicines regulatory authority.
He holds a MD degree from the University of Goettingen, Germany, and has a background in Internal Medicine and Clinical Pharmacology (specialist degree).
Mr. Neil Clark, PrimeVigilance CEO, said “We are very pleased to welcome Dr Seebeck to our senior management team. He brings his great experience of pharmacovigilance and the regulatory and services sector to our fast growing medical group and will play an important role with the rest of our team in continuing the growth pf PrimeVigilance as a leading provider of global pharmacovigilance and medical information services”
****
About PrimeVigilance
The pharmacovigilance (PV) services offered by PrimeVigilance cover all the regulatory and scientific elements of PV required to obtain and maintain a product license within Europe: Qualified Person, 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 fully integrated international Medical Information services.
PrimeVigilance has grown organically since 2008 and now has 100 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 further information please visit www.primevigilance.com or alternatively please contact:
Neil Clark, CEO
Phone: +44 (0) 1225 731349
E-mail: neil.clark@primevigilance.com
Dr Joerg Seebeck, CMO
Direct Line: +44 (0) 1483 307920 ext 1023
E-mail: Joerg.seebeck@primevigilance.com

NEWS: WHO/UMC research project “Monitoring Medicines” contribution from PrimeVigilance director Elliot Brown

PrimeVigilance is pleased to share with you the news that Dr Elliot Brown, PrimeVigilance Director, has recently completed his participation as a consortium member in a 4 year pharmacovigilance research project ‘Monitoring Medicines’. The project, funded by the Seventh Framework Programme (FP-7) of the Research Directorate of the European Commission (EC), was coordinated by the WHO / Uppsala Monitoring Centre. Its four themes were:

  • Strengthening consumer reporting
  • Pharmacovigilance centres collecting problems related to inappropriate drug use
  • Better use of existing global pharmacovigilance data
  • Developing active and focussed pharmacovigilance systems.

NEWS: Hikma Globalizes Pharmacovigilance Activities together with PrimeVigilance

Guildford, UK – January 28th 2014. PrimeVigilance a leading international company that provides pharmacovigilance (PV) and medical information services announced a new services agreement with Hikma Pharmaceuticals, the fast growing multinational pharmaceutical group, to provide Hikma with quality and global-scale PV services.
Pharmacovigilance or Drug Safety, is the pharmacological science relating to the monitoring, detection and prevention of adverse effects with pharmaceutical products.
This agreement will enable Hikma to globalize all its PV operations across its worldwide group of companies, and assist Hikma in covering all the regulatory and scientific elements of PV required by health authorities in different countries.
In addition, Hikma will better monitor and evaluate the benefit-risk balance of its products, and will be more compliant with the highest standards of quality, international regulations, and codes of best practices. The agreement will also re-enforce Hikma’s commitment to compliance with laws & regulations.
Mr. Said Darwazah, Hikma Pharmaceuticals’ CEO, said “I am pleased to announce this partnership with PrimeVigilance, which will enable us to maintain our highest standards of quality. Through this partnership, we fulfill our commitment to the safety of our patients wherever we operate in compliance with all applicable laws and regulations.”
Mr. Neil Clark, PrimeVigilance CEO, said ”We are very pleased to be working with Hikma and providing a range of important safety services to support their fast-growing, international operations.”
-END-

About PrimeVigilance

The pharmacovigilance services offered by PrimeVigilance cover all the regulatory and scientific elements of PV required to obtain and maintain a product licence within Europe: Qualified Person, Risk Management Planning (RMP), and a compliant PV System with consistent Adverse Event data capture, robust Quality Management, expedited reporting, preparation of PSURs, literature screening, signal detection and evaluation, benefit-risk assessment, compliance auditing, support during crisis and various ad hoc assignments. PrimeVigilance also offers fully integrated international Medical Information service.
PrimeVigilance has grown organically since 2008 and now has over 90 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 further information please visit www.primevigilance.com or alternatively please contact:
Neil Clark, CEO
Phone: +44 (0) 1225 731349
E-mail: neil.clark@primevigilance.com
About Hikma
Hikma Pharmaceuticals is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non branded generic and in-licensed products. Hikma’s operations are conducted through three businesses: “Branded”, “Injectables” and “Generics” based principally in the MENA region, where it is a market leader, the United States and Europe.
For news and other information, please visit www.hikma.com.
VARCC–Arabian Communications
Name: Sara Haddadin
Email: sara.haddadin@varcc.com
Tel: (+962) 6 5547161
Fax:(+962) 6 5547162
HIKMA Pharmaceuticals
Name: Hana Ramadan, Dana Shekem
Email: hramadan@hikma.com, dshekem@hikma.com
Tel: Hana Ramadan (+962) 6 5802900 Ext. 313, 311

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