Elliot Brown Consulting and Ergomed CRO have launched PrimeVigilance, a new pharmacovigilance services company. Founded by two globally respected experts, the newly formed PrimeVigilance Ltd. provides a unique offering in the field of pharmacovigilance, more here...
28th July 2010:
Elliot Brown Consulting is pleased to announce its participation as a partner in a major new international research project. The project is funded by the European Commission (FP-7, Research Directorate), and aims to improve patient safety within countries of the EU and in other regions. The project, coordinated by the Uppsala Monitoring Centre will run for 3½ years. The partners in the consortium comprise:
Uppsala Monitoring Centre; WHO Headquarters; Lareb, Netherlands Pharmacovigilance Centre; 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; Zuellig Family Foundation, The Philippines; and Elliot Brown Consulting Ltd, UK.
The project has four objectives:
1. to support and strengthen consumer reporting of suspected ADRsThe consumer reporting element of the project will include a review of direct consumer reporting practices of suspected ADRs in countries where consumer reporting is already in place, followed by recommendations of best practices, a guideline for consumer organizations on reporting of ADRs and incorporation of consumer reporting in the UMC Vigibase.
The medication errors project aims at encouraging national pharmacovigilance centres to expand the collection, analysis and dissemination of information on adverse events relating to drug prescribing, dispensing and administration and to develop a guideline on the analysis of medication errors contained in national pharmacovigilance databases.
The project on better use of existing pharmacovigilance data will analyse global data through advanced data-mining to better identify medicines with dependence liability and medicines of substandard quality.
Development of additional methods for pharmacovigilance will involve tools to expedite the characterization of early signals identified through spontaneous reporting, with an emphasis on active follow-up of exposed patients and particularly Cohort Event Monitoring (CEM), with development of guidelines on this. Pharmacovigilance centres will collect reports of adverse events in patients treated with medicines for HIV/AIDS or malaria, using active and focussed surveillance methods.
A pilot pharmacovigilance database will be set up by merging ADR data on anti-retroviral medicines from several sources, with a user-friendly web-based query tool to enable healthcare workers to retrieve information. A web-based distance learning tool will assist healthcare workers in evaluating the ADR information retrieved, and a risk score calculation tool will be produced, to allow evaluation of ADRs based on clinical data.
The progress of the Monitoring Medicines project will be reported periodically on www.monitoringmedicines.org. For further information please see Uppsala Reports 49, April 2010 http://who-umc.org/graphics/22973.pdf.
22nd July 2010:
7th December 2009:
Elliot Brown Consulting and PrimeVigilance are currently seeking an exceptional senior pharmacovigilance professional to head up and further develop the operations of our successful and growing quality-oriented Europe-based pharmacovigilance services company, with a current portfolio of clients in Europe, North America and the Pacific Rim. The successful candidate will have both hands on and management experience in the day-to-day running of pharmacovigilance operations within either a multinational pharmaceutical company or contract organisation.
More details here.
28th October 2009:
Elliot Brown Consulting are delighted to announce that chief executive Elliot Brown was elected to serve on the Executive Committee of the International Society of Pharmacovigilance at the annual meeting in Reims, France.
2nd September 2009:
Elliot Brown Consulting Ltd are pleased to announce the appointment of a new Associate Consultant to the EBC fold.
I am delighted to inform you that Dr Jan-Willem van der Velden has set up a PV consultancy and is joining EBC as an associate. Jan-Willem is well known within the pharmacovigilance community, having worked at top levels for several companies, including ii4sm, Pharmanet, Yamanouchi and Solvay. He is a Fellow and Past President of the International Society of Pharmacoepidemiology and holds an academic position at the University of Brussels. I am sure that you will join me in wishing him every success with his new company, Mesama Consulting.
1st June 2009:
EBC Associate Stephen Goldman is pleased to announce the launch of his company's new website for Stephen A. Goldman Consulting Services LLC.
More information can be found at www.sagcs.com
Elliot Brown Consulting and the NDA Group announced today that they will collaborate to share knowledge, experience and resources in order to consolidate their established positions as leading global service providers within the areas of Risk Management and Pharmacovigilance. Each company will retain its own identity and accountability. Through this alliance, they can pool resources and benefit from each other’s expertise with the objective of improving the service to their respective clients in the areas of:
The companies will begin this collaboration on 2nd June 2008. As part of this alliance, Dr Elliot Brown will join the management team of the NDA Risk Management & Pharmacovigilance business unit whilst maintaining his position as Managing Director of Elliot Brown Consulting Ltd.
CEO of NDA, Dr Lars-Helge Strömquist:
“Increasingly society expects that the pharmaceutical industry takes a robust lead in showing accountability for the quality and safety of its medicines. To be able to meet the challenges that such accountability brings, the industry needs a partner that is internationally recognised as standing for quality and excellence within the areas of risk management and patient safety. With the new alliance between Elliot Brown Consulting Ltd and the NDA Group, the industry now has a partner uniquely qualified to perform this role. We will provide the pharmaceutical industry with our mutual wealth of competence and experience as we understand the current global development environment. We intend to be the leading service provider in this important field as we believe that this is the best way for all of us to serve the customer who really matters: the patient.”
MD of Elliot Brown Consulting, Dr Elliot Brown:
“The sustained success for a Pharma company goes hand in hand with professional risk management which helps minimise the risk of unwelcome surprises. NDA has an excellent record in achieving MAA status and maintaining products and together we can provide best in class support in RM/PV.”
For further information please contact
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Dr Elliot G Brown Managing Director Elliot Brown Consulting +44 (0) 208 4498788 |
Dr Brian Edwards Director, Pharmacovigilance and Drug Safety NDA Regulatory Science Limited +44 (0) 1372 862 61
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The NDA Group is an independent consulting organization focused on the strategic and operational aspects of regulatory affairs. NDA provides assistance to both the Pharmaceutical Industry as well as Regulatory Agencies. The ultimate objective of NDA is to help to develop better medicines that reach the patient without unnecessary delay. NDA achieves this objective by critically reviewing client project development plans with the aim that they are optimized to meet the needs of regulatory authorities and then to help to implement those strategies. NDA strives to bridge the communication gap between "the regulators" and "the regulated" to the benefit of patients.
Elliot Brown Consulting is an independent consultancy providing a dedicated pharmacovigilance resource for the international pharmaceutical and biologicals industries, with a team of highly experienced consultants and associates. Its clientele on 4 continents ranges from the smallest to the largest of organizations and encompasses innovative corporations, generic manufacturers, contract organizations and regulatory agencies.
More information can be found at www.ndareg.com and www.ebconsulting.co.uk
17th October 2008:
Elliot Brown Consulting are pleased to announce the appointment of a new Associate Consultant to the EBC fold.
Dr. Barton Cobert has extensive experience in drug safety and pharmacovigilance as well as in clinical research, regulatory affairs, risk management and quality control/compliance/audits. He has held senior positions in drug safety with major pharmaceutical companies for over 2 decades and is the author of the Manual of Drug Safety & Pharmacovigilance and co-author of Practical Drug Safety from A to Z as well as being widely published in refereed journals. Dr. Cobert will help EB Consulting further consolidate their position in the US and Canadian market and we welcome him onboard.
4th August 2008:
Elliot Brown Consulting are pleased to announce the appointment of a new Associate Consultant to the EBC fold. Inês Ilharco Ferreira is a specialist in pharmacovigilance systems auditing and training; her experience will augment our already extensive client offering. In collaboration with Elliot Brown Consulting, Inês can offer assistance and advice in preparing for pharmacovigilance inspections and audits and we are delighted to have her on board.
3rd June 2008:
Elliot Brown Consulting and the NDA Group announced today that they will collaborate to share knowledge, experience and resources in order to consolidate their established positions as leading global service providers within the areas of Risk Management and Pharmacovigilance.
21st May 2008:
Elliot Brown Consulting Ltd are pleased to announce the appointment of a new Associate Consultant to the EBC fold.
Steve Douglas has spent the last 30 years working in the pharmaceutical industry and the last 8 years as a Senior Director and Principal Pharmacovigilance Consultant with Parexel. He has acted as a Qualified Person for Pharmacovigilance within the EEA and specializes in the development of compliant PhV systems. Steve brings huge experience and expert knowledge which will be a great asset to the Elliot Brown Consulting team.
27th February 2008:
Elliot Brown Consulting Ltd are pleased to announce the appointment of a new Associate Consultant to the EBC fold.
UK-based Natalie Smith brings a wide breadth of experience in drug safety/pharmacovigilance having served as EU Qualified Person at Shire HGT. In collaboration with Elliot Brown Consulting, Natalie can offer assistance and advice in implementing and validating PV databases, MHRA inspections and all aspects of pharmacovigilance.
3rd December 2007:
Elliot Brown Consulting Ltd are pleased to announce the appointment of a new Associate Consultant to the EBC fold.
Ian Boyd, late of the Australian Therapeutic Goods Administration (TGA) began his career as a research chemist before becoming the Executive Officer of the Adverse Drug Reactions Unit of the TGA, a position he held for 19 years until 2007. He was also Secretary of the Australian Adverse Drug Reactions Advisory Committee (ADRAC) for 14 years. He has published widely in the area of pharmacovigilance as well as being a major contributor to the Australian Adverse Drug Reactions Bulletin which is the major flagship of ADRAC. He has represented Australia at annual meetings of national centres participating in the WHO Drug Monitoring Programme on many occasions. More recently, he led the TGA's Adverse Drug Reactions Unit in the redevelopment of their IT infrastructure especially in the area of electronic lodgement of ADRs, conversion to MedDRA and the development of reporting and analysis tools.
Elliot Brown Consulting is delighted to welcome Ian not only for his unique expertise, but also in adding the Pacific Rim to our global consulting portfolio.
21st October 2007:
We are very sad to announce that our Associate Consultant and friend Carla Hagelberg passed away on 18th October after a long illness borne with remarkable courage.
Elliot Brown Consulting Ltd are pleased to announce the appointment of a new associate, Dr. John Pincott, to the EBC fold.
Dr. John Pincott has established a pharmacovigilance consultancy Pincott MediLex Ltd having previously been European and Global Head of Pharmacovigilance, and EU Qualified Person in a succession of companies. He has also successfully pursued several other safety projects, such as establishing a worldwide network of clinical pathology laboratories to support clinical trials, and integrating preclinical safety into the wider development process.
10th February 2006:
Elliot Brown Consulting Ltd are pleased to announce the arrival of a new Associate Consultant into the EBC fold.
UK-based Stuart Albaya brings a wide breadth of experience in drug safety/pharmacovigilance but with particular expertise in process management. Albaya Consulting Ltd are able to offer a global service either independently or in close collaboration with other renowned companies/consultancies from the preparation of a simple SOP through to the complete evaluation of departmental procedures.
Elliot Brown Consulting Ltd
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