SCOPE — Development of Web Form for Adverse Drug Reactions.

Descriptions

The Strengthening Collaboration for Operating Pharmacovigilance in Europe (scope) Joint Action aims to help medicines regulators operate pharmacovigilance systems to meet the EU legislative requirements.Regulators are collaborating to improve skills and capability across the European network, which will help safeguard public health in both national territories and the EU as a whole.The SCOPE Joint Action will run from 2013 until October 2016. It has been created to support operations of pharmacovigilance in Europe following new requirements introduced by the European pharmacovigilance legislation that came into effect in June 2012.Funded by the Consumers, Health and Food Executive Agency (CHAFEA) and with contributions from Member States involved, SCOPE will gather information and expertise on how regulators in Member States run their national pharmacovigilance systems.Using this information, scope will develop and deliver guidance, training, tools and templates to support best practice. Through this approach SCOPE aims to support consistent approaches in pharmacovigilance operations in the EU network, which will benefit the safety monitoring of medicines and communications outputs, thereby helping to safeguard public health.Scope has 6 high level objectives:1. Enable Member States to develop a fuller understanding of, and develop best practice in, reporting mechanisms for adverse drug reactions (ADRs).2. Implement shared understanding of best practice in signal management across the EU network.3. Define best practice in Risk Communications through the creation of a standardised toolkit.4. Enable Member States to develop, understand, and assess their quality management systems for pharmacovigilance.5. Develop a competency framework to support exemplary pharmacovigilance throughout the product lifecycle.6. Create a forum for interaction amongst European National Competent Authorities to strengthen regulatory collaboration. This will lead to improved understanding of the different challenges faced by member states.2. Requirements.A web-based form for reporting of Adverse Drug Reactions (ADRs) to medicinal products by healthcare professionals and patients is required. The planned outcome of the process is to provide European National Competent Authorities (NCAs) with a template web-form that can be translated and adapted for use within their own country.The development of the web based form for reporting of ADRs forms part of Topic 4 (Review of reporting forms) within Work Package 4. The tool will enhance the engagement of European healthcare professionals and patients, who play an essential role as the primary source of spontaneous ADR information and SCOPE is aiming to facilitate improved ways of ADR reporting to national regulators.This output from this will be a framework agreement that any European National Competant Authority can call off, the contract will run for a period of three years with the option to extend by a further 12 months.The requirements are:— A one off piece of work, to produce a web-based form within budget. This will be ordered by the MHRA on behalf of the SCOPE project.— Optional work to cover customisation; branding, additional fields (if required) for participating countries to integrate the form into their applications and for the translation of the form if needed. This will be subject to individual call offs (orders) by individual National Authorities.This Framework will be available for the use of any SCOPE partners as listed on the SCOPE website http://www.scopejointaction.eu