pharmacovigilance - medical - regulatory - Elliot Brown Consulting Ltd

News

12th October 2011:

ISoP2011 sessions:

Further details of the training session to be held by Dr. Elliot Brown at ISoP2011 have been released. Elliot Brown will be running a training session on Audits and inspections at the Annual meeting of the International Society of Pharmacovigilance in Istanbul on 25th October, 2011.

In addition he and Lesley Fram will be presenting papers on training in pharmacovigilance at the International Society of Pharmacovigilance in Istanbul on 27th October, 2011. Abstracts of these papers were published in "Drug Safety" - the journal of the International Society of Pharmacovigilance under the following titles:

Training on Risk Management Planning Brown E. Drug Safety 2011;34(10): 896
The application of pedagogy to training in pharmacovigilance. Fram L, Brown E. Drug Safety 2011;34(10): 899

10th October 2011:

Elliot Brown Consulting announce Recent Publication

Elliot Brown Consulting are pleased to announce the publication of a paper by Dr. Brown. The paper, entitled "Preparing for Development Safety Update Reports: some implications for pharmaceutical companies", was published the August 2011 edition of "Pharmacovigilance Review"

27th July 2011:

Elliot Brown to chair two sessions at ISoP2011

Dr Elliot Brown, Managing Director of EBC and Director of PrimeVigilance Ltd will be chairing two sessions, one on Risk perception and the other on Training in Pharmacovigilance and Risk Management at the forthcoming ISOP annual conference in Istanbul. He will present a paper on Training and Risk Management and Lesley Fram, EBC's training consultant, will present a paper on "Teaching methods and pharmacovigilance training" at the conference.

28th July 2010:

Elliot Brown Consulting to participate as partner in major new international research project

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 ADRs
2. to expand the role and scope of national pharmacovigilance centres to identify, analyze and prevent medication errors
3. to promote better and broader use of existing pharmacovigilance data for patient safety
4. to develop additional pharmacovigilance methods to complement data from spontaneous reporting systems.

The 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:

Elliot Brown Consulting Welcomes Associate Consultant Professor Ralph Edwards

We are delighted to announce that Professor Ralph Edwards, former Director at the WHO Uppsala Monitoring Centre (UMC) has joined EBC as an Associate Consultant in Pharmacovigilance, Risk Management and Medicolegal matters. As well as bringing his extensive knowledge, experience and high reputation as a leading figure in pharmacovigilance, he provides us with a new capability for consultancy on medicolegal matters, having appeared as an expert witness in several jurisdictions, including the UK, New Zealand, the USA and Hong Kong.

Prof. Edwards trained in both general internal medicine and clinical pharmacology. He has been a practicing specialist physician and also taught at undergraduate and graduate levels in both areas for 17 years. He worked in clinical toxicology in the fields of drug abuse, acute and chronic poisoning, toxicity from industrial chemicals as well as adverse drug reactions. He held various posts at the University of Sheffield Medical School and United Sheffield Hospitals (UK) then at the University of Leicester Medical School and Hospitals (UK). From 1978-1981 he was Professor of Medicine at the University of Zimbabwe, Consultant physician, a Founder member of ISLAND hospice team, Zimbabwe and Consultant and Board member, Drug Abuse Support Team, Harare. Between 1981 and 1990 Ralph Edwards was Director of the National Toxicology Group and Associate Professor in Clinical Pharmacology, Otago University and Medical Research Council, Consultant Physician, Dunedin Hospital, Chairman, Dunedin Hospital Therapeutics Committee, Medical Assessor for Adverse Drug Reactions, Ministry of Health New Zealand and a member of various advisory committees in New Zealand. From 1985 to 1990 he was Chairperson of the Advisory Group, WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden. From 1990 to 2009 Ralph was Director of the Uppsala Monitoring Centre and is currently Medical Advisor to that body.

He was previously external examiner in clinical pharmacology, University of Zimbabwe, Cape Town and Witswatersrand Universities, South Africa and in Clinical Toxicology, University of Cardiff, UK, President, International Society of Pharmacovigilance (2000-2004), Member, WHO Expert Advisory Group on Essential Drugs (2000-2002), Member, WHO Expert Advisory Group on Narcotic and Psychotropic Drugs (2002). In the last ten years his research has been in the identification and confirmation of ADRs using post-marketing cohort studies; international analysis of ADR and toxicology case report rates, drug use and demography. Recent focus has been on drug benefit-risk analysis and the use of data mining as an aid to the analysis of large amounts of case data. He has published more than 200 scientific papers.

7th December 2009:

Elliot Brown Consulting and PrimeVigilance seek to appoint Director of Global Pharmacovigilance Operations

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 .

28th October 2009:

Elliot Brown elected to Executive Committee of ISOP

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 Welcomes Associate Consultant Dr Jan-Willem van der Velden

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 A. Goldman Consulting Services launch new website

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

17th October 2008:

Elliot Brown Consulting Welcomes Associate Consultant Barton Cobert

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 Welcomes Associate Consultant Inês Ilharco Ferreira

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.

21st May 2008:

Elliot Brown Consulting Welcomes Associate Consultant Steve Douglas

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 Welcomes Associate Consultant Natalie Smith

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 Welcomes Associate Consultant Ian Boyd

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:

Carla Hagelberg

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 Welcomes Associate Consultant John Pincott

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 Welcomes Associate Consultant Stuart Albaya

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.

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