Future Development of European Risk Management Strategies

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Chapter: Pharmacovigilance: Risk Management - a European Regulatory View

The focus on delivering risk management plans in practice which followed the implementation of new Euro-pean Legislation did not curtail the wider debate about future development of European risk management.


FUTURE DEVELOPMENT OF EUROPEAN RISK MANAGEMENT STRATEGIES

The focus on delivering risk management plans in practice which followed the implementation of new Euro-pean Legislation did not curtail the wider debate about future development of European risk management.

THE ERMS ACTION PLAN

The development and population of EudraVigilance by the member states, enabling signal detection from a substantial European database is a major strate-gic objective. The advantage for rapid, robust signal detection from a population base of over 450 million people is clear. The ‘downstream’ work of impact analysis and risk assessment would also benefit from collaborative working, following the pilot study by a small group of member states sharing the eval-uation of periodic safety update reports. This pilot study was triggered by the results of a high-level survey of member states resources for pharmacovig-ilance conducted in 2003–04, which found that the total number of staff engaged in pharmacovigilance in Europe was only around 340 full-time equivalents with around 40% involved in data management.

EUROPEAN COMMISSION

On 15 March 2006, the European Commission (DG Enterprise) published an independent assessment of the European Community system of pharmacovigi-lance. This broad-ranging assessment based on the results of a questionnaire and interviews with phar-macovigilance staff in national authorities highlighted the strengths and weaknesses of the European system of pharmacovigilance as operated by the network of member state agencies. The report’s recommenda-tions focussed on: the breadth and variety of data sources; the proactive use of the legislation; the speed of decision-making; the impact of regulatory action and communication; compliance    by marketing authorisation holders; and general principles of qual ity management and continuous quality improvement.

INNOVATIVE MEDICINES INITIATIVE

In July 2005, the European Commission (DG Research) published the Innovative Medicines Initia-tive Strategic Research Agenda whose objective is to accelerate the development of safe and more effective medicines by joint public and private collaborations. The main recommendations concerning safety evalua-tion include the creation of a European Centre of Drug Safety Research (ECDS) to identify and co-ordinate research needs in safety sciences. The ECDS as envis-aged would cover issues of non-clinical safety as well as pharmacovigilance and risk management. Prior-ity areas for research in pharmacovigilance and risk management include development of methodologies and networks, and novel methods of risk prediction and benefit–risk assessment, including decision anal-ysis tools. The establishment of the proposed ECDS will depend on availability of funding.

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