Defence Online

The current contract for Graphic design services in London is projected to end on 23/3/2017 and may be available for re-tender.The current contract for Graphic design services in London included 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:— Learning aim.— Develop and deliver guidance, training, tools and templates to support best practice in pharmacovigilance assessment across the EU.— Learning outcome.— Improve skills and capability of pharmacovigilance assessors across the European network to help safeguard public health in both national territories and the EU as a whole.— Evaluation of training.— The number and range of pharmacovigilance assessors who use the training modules.— Post learning feedback through a user evaluation form.— Key audience.— Pharmacovigilance teams in all 28 EU member states.Someone working in a pharmacovigilance team is likely to have a degree in pharmacy, pharmacology, nursing, physiology, toxicology or another relevant scientific discipline.The role is primarily responsible for the capture of adverse drug reaction (ADR) reports and pharmacovigilance signal detection and assessment procedures to ensure drug safety issues and risks to public health are identified and evaluated.Website platform.The learning content will be delivered online, accessed from the existing scope website. A ‘Learning’ tab needs to be added to the home page to link to the new content.The learning content needs to be optimised and accessible through mobile devices:tablets and smart phones.The learning content needs to meet recognised industry standards for accessibility.The content will be moved to another website in the future so will need to be designed to be easily extracted or moved from the scope website.Authoring package.We require a simple authoring package solution that requires minimal / basic training so we can easily access and update content ourselves. Adobe Captivate would be our preference. We may require basic training in the package when appropriate in the project.Learning management system:We would like to explore the option of a simple easy-to-use learning management system so users can register, we can monitor usage and issue learning completion certificates which could count towards professional CPD.All learning content should be interactive material built to SCORM (Shareable Content Object Reference Model) standards.Template-based system:We require branded templates designed so learning content can be uploaded in the future quickly and easily. The range of templates to be proposed by the supplier once the learning content has been reviewed.We would require training and clear guidance notes on how to use any templates and systems developed.