Press Release Guildford, UK, 13 April 2017

PrimeVigilance Press Release

PrimeVigilance Management Changes

 Guildford, UK – 13 April 2017

PrimeVigilance is pleased to announce that Dr. Jan Petracek will step into the role of Chief Executive Officer of PrimeVigilance. Jan joined the Ergomed group, the owners of PrimeVigilance, in November 2016 as CEO of European PharmInvent Services s.r.o. following its acquisition and subsequent integration into PrimeVigilance.

Neil Clark will step down as CEO of PrimeVigilance with effect from 16 April 2017. Neil is leaving to become Chief Executive Officer of Destiny Pharma Limited, a company focused on the discovery, development and commercialisation of novel antimicrobials. Neil will remain on the Board of PrimeVigilance, as a non-executive director and a consultant during a transition period.

Dr. Miroslav Reljanovic, Chief Executive Officer of Ergomed, said:

 “I would like to give my sincere thanks to Neil for his eight years’ service to Ergomed. He has helped the Company transition from a private company through the IPO process in 2014 and latterly, overseen a period of strong growth in PrimeVigilance. I wish him all the best in the next stage of his career.

“We are fortunate to have in the wings a replacement CEO of the calibre of Dr. Jan Petracek. As founder of PharmInvent and former regulator at EMA, his unique combination of entrepreneurship and specialist pharmacovigilance expertise will serve to drive forward our pharmacoviglance businesses.”

 – END –

 About PrimeVigilance

 PrimeVigilance is a Pharmacovigilance (PV) and Medical Information Services company with an established international footprint and a heritage of excellence and leadership in the field of pharmacovigilance.

PrimeVigilance was established in 2008 and offers a comprehensive, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders have an unrivalled reputation in the sector with a network of expert associates across the world. These include former senior regulators and consultants with extensive industry experience, especially with marketed products.

Expert pharmacovigilance services

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 specialises in helping emerging companies comply with regulations, from developing the initial PSMF and RMP to full management of safety operations.

A global reach

PrimeVigilance has grown organically since 2008 and now has now over 350 staff employed in its main offices in UK, Europe and USA, as well as an international network of consultants. PrimeVigilance is currently providing services across 100 countries.

For more information contact PrimeVigilance or visit www.primevigilance.com

About Ergomed

Ergomed plc is a profitable UK-based business providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. It operates in over 50 countries.

Ergomed provides clinical development, trial management and pharmacovigilance services to over 100 clients ranging from top 10 pharmaceutical companies to small and mid-sized drug development companies. Ergomed successfully manages clinical development from Phase I through to late phase programmes.

Ergomed has a wide therapeutic focus, with a particular expertise in oncology, neurology and immunology and the development of orphan drugs. Ergomed believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed and the physicians involved in clinical trials.

As well as providing high quality clinical development services, Ergomed is building a portfolio of co-development partnerships with pharma and biotech companies which share the risks and rewards of drug development. Ergomed leverages its expertise and services in return for carried interest in the drugs under development. Lastly, Ergomed recently acquired a pipeline of proprietary development products for haemostasis in surgical settings. For further information, visit: https://ergomedplc.com.

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