Elliot Brown Consulting is a partner in a major international research project funded by the Seventh Framework Programme (FP-7) of the Research Directorate of the European Commission (EC).

"Monitoring Medicines" involves a) methodological development in direct patient reporting of suspected adverse reactions b) better analysis of reasons for medication errors c) improved approaches to active and focused medicine surveillance d) identification of early indicators of drug dependence and substandard medicines in medicine safety databases and e) decision support tools for treatment of HIV/AIDS

The partners in the project cover a wide range of organisations dedicated to improving public health through safer use of medicines; they are:

• Medical Products Agency, Sweden
• National Patient Safety Agency, UK
• Copenhagen HIV Programme, Denmark
• University of Ghana Medical School
• Pharmacy and Poisons Board, Kenya
• Centre Anti Poison et de Pharmacovigilance du Maroc
• Lareb, Netherlands Pharmacovigilance Centre
• Zuellig Family Foundation, the Philippines
• Elliot Brown Consulting Limited, UK
• World Health Organization
• Uppsala Monitoring Centre, Sweden (UMC, the overall project co-ordinator)

The overall aim of "Monitoring Medicines" is to strengthen what we know about medicines and their use, sharing that knowledge and putting the knowledge to use to reduce patient deaths and adverse effects due to medicines. The project will help to advance the application, co-ordination and optimal use of pharmacovigilance evidence, and to strengthen the links between the various individuals, national pharmacovigilance centres and experts involved. Most importantly, the project will strive to increase consumer involvement in the reporting of adverse drug reactions (ADRs), and mobilize and sustain political commitment to support those working in drug safety.

Founded by two globally respected experts, PrimeVigilance Ltd. provides a unique offering in the field of pharmacovigilance (PV).

PrimeVigilance specialises in helping emerging and established companies to comply with regulations, from full management of safety operations to specialist consulting. Its comprehensive services cover all the regulatory, medical and scientific elements of PV required to obtain and maintain a product licence within Europe, including:

• EU Qualified Person

• Detailed Description of PV System

• Validated ARISg safety database

• A compliant PV System with robust Quality Management, consistent: adverse event data capture and expedited reporting, preparation of PSURs, literature screening, signal detection and evaluation, benefit-risk assessment, compliance auditing, risk management planning, support during crisis, etc.

PrimeVigilance is a multinational company, registered in the UK with bases across four continents, providing innovative, top quality, cost-effective safety operations for small and medium-sized pharmaceutical and biotechnology companies. Originally set up as a joint venture between Dr. Elliot Brown and Dr. Miroslav Reljanovic, the founder of the Ergomed Group, PrimeVigilance quickly grew to establish an international footprint and a culture of excellence and leadership.

Dr. Elliot Brown's existing consultancy has an enviable reputation of over a decade in PV, with a network of expert associates spanning three continents. These include former senior regulators and consultants with extensive industry experience. To complement this top-level, global consultancy support, the Ergomed Group brings an experienced operational dimension to the PrimeVigilance offering. With offices in the UK, Germany, Southern and Eastern Europe, Russia, the USA and the middle-East, the Ergomed Group is a quality-focused organisation with outstanding staff and many years experience with the ARISg safety database and clinical safety management.

PrimeVigilance will fill the gap between the large multinational CROs that do not provide a service geared towards post-marketing surveillance for small- and medium-sized companies, and the small service providers that do not have the critical mass, expertise or wide international presence needed to reassure that patients and products will be adequately protected.

Phone: +44 (0) 1483 688 349
Fax: +44 (0) 1483 688 348

info@primevigilance.com