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.”
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
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.
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