Upcoming Webcasts

Register™ 5: Automating the Tracking of Regulatory Submissions

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Tuesday, May 6, 2008
9:00am EDT / 2:00pm BST / 3:00pm CEST

Thursday, May 8, 2008
12:00pm EDT / 5:00pm BST / 6:00pm CEST

For most life science organizations it is the coordination of activities and resources that has the highest impact on the quality, speed and cost of a submission and ultimately its success. Many companies currently rely on manual processes to create, manage, distribute and track project plans associated with regulatory submissions and have no global view of potential delays or resource conflicts. Register 5 addresses this gap by automating the definition, distribution and reporting of project plans at the global and local/regional level.

Attend a complimentary, 45-minute webcast, including live product demo, to learn about the newest version of Register, the proven solution for global product portfolio management. Attendees will have a close-up look at the Register 5 planning module that enables companies to:

• Link project plans with registrations and updates
• Automate definition, distribution of reporting of project plans
• Create planning templates that are definable for each regulatory procedure type
• Establish and re-use plan templates: define dependencies; assign owners, roles, resource types and more; specify high-level and granular activities
• Create and publish local plans for each country with a single click of a button
• Intelligently update various activities within Register, based on defined business rules
• Access productivity-related metrics
• Run generic and productivity reports to track actual versus planned milestones, and export project plans to other Microsoft® applications

Madame, Monsieur,

Aris Global vous invite à participer à deux sessions de présentation web:

ARISg™ 6 : Aller au delà de la conformité en matière de Sécurité Sanitaire
Le jeudi 12 juin 2008 à 15.00

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Suite aux récents retraits de médicaments qui ont ébranlé la confiance des patients, celle des professionnels de santé et des agences, les sociétés des sciences de la vie doivent démontrer leur volonté d'assurer une sécurité de leurs produits de santé qui va au delà de la simple conformité.

Vers la sécurité totale: les nouvelles solutions du spécialiste mondial de la sécurité.

Aris Global annonce que la version 6 d'ARISg, le 1er système mondial de pharmacovigilance et de sécurité est dorénavant disponible. Ses nombreuses améliorations et ses nouvelles caractéristiques apportent une solution qui répond aux enjeux mondiaux auxquels vous devez faire face en matière de sécurité.

Inscrivez-vous pour la présentation web présentée par Aris Global : des solutions nouvelles et améliorées pour une Sécurité Totale. Celle-ci est présentée en trois parties : une brève introduction, une démonstration en direct, et une partie réservée aux questions réponses.

Participez à cette présentation web de 60 minutes pour découvrir la nouvelle interface utilisateur d'ARISg, le support complet des méthodes de maintien d'aveugle/levée d'aveugle des cas cliniques, l'amélioration des processus de communication internes et externes, et bien davantage encore.

agInquirer™ : gestion des informations médicales
Le mardi 17 juin 2008 à 15.00

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Vos services médicaux doivent répondre quotidiennement à des questions concernant les dosages médicaux, les effets secondaires dus aux combinaisons de médicaments, les réactions potentielles, les utilisations possibles en dehors de celles prévues dans les notices d'utilisation et l'automédication.

Nous vous présentons : agInquirer
agInquirer est une solution complète qui facilite l'enregistrement, l'acheminement, la gestion et le traitement des demandes de renseignements médicaux.

Participez à la présentation web de 60 minutes où nous vous expliquerons comment agInquirer facilite au quotidien les tâches des services d'information médicale en fournissant une solution simple et performante pour gérer et distribuer une information exacte, fiable et cohérente concernant vos produits aux patients comme aux professionnels de santé.

Inscrivez-vous aujourd'hui auprès de Florence Burey-Abraham : fbureyabraham@arisglobal.com ou Dawn Williams dwilliams@arisglobal.com

Cordialement

Marcel Jedrzejczak
Sales manager - Southern Europe

Florence Thonier
Solutions specialist, Drug Safety

Check our list of archived Webcast presentations that are available for viewing

Archived Webcasts

agSignals™ and agComposer™: Maximizing Safety and Minimizing Risk

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Attend this 60-minute webcast to learn about agSignals, a streamlined and efficient solution that provides end-to-end process support for signal detection and risk/benefit management activities. agSignal's optimized database, powerful front-end reporting and analysis tools, trending reports and business analytics will be demonstrated. You will also learn how agComposer enables end-to-end periodic and aggregate reporting and can be integrated with clinical trial, regulatory and medical information databases. When integrated with each other, agSignals and agComposer facilitate the creation of aggregate reports in accordance with regulatory requests and commitments.

agXchange IRT™: Automating Case Receipt

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Attend this 45-minute webcast to learn about agXchange IRT, a new solution for electronic exchange that decreases the amount of time organizations spend collecting and verifying safety information and increases their ability to report complete and accurate safety information on time. Learn about agXchange IRT's many features and capabilities that enable organizations to more closely integrate their affiliate offices into the process of collecting and submitting safety information.

ARISg™ 6: Moving Beyond Safety Compliance

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ARISg, the world's leading pharmacovigilance and safety system, is releasing version 6, and its many enhancements and new features deliver a solution that meets the real-world safety challenges you face. Attend this 45-minute webcast to learn about the ARISg updated user interface, extended support for blinding/unblinding, personalized user dashboard, integrated metrics reports, enhanced communication management, and much, much more.

Regulatory and Manufacturing: A Strategy for Bridging the Compliance Gap

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Company reputation, brand identity and financial performance are powerful indications of an organization's success...or failure. With product recalls and market withdrawals on the increase, pharmaceutical, biotechnology and medical device companies significantly improve their chance for success when regulatory and manufacturing bridge the compliance gap. By working from a centralized hub of approved specifications, companies can make better and informed business decisions while lowering the costs for tracking regulatory submission and monitoring obligations with regulatory authorities.

Attend a complimentary, one-hour webcast to hear about a proven strategy that better ensures global product portfolio management. Experts from Aris Global and SAP will discuss:

• The Compliance Gap: Where does it exist? And how do you know if you have one?
• Compliance manufacturing: Practical ways to lessen the risk of compliance failure
• Register™ - Certified to run on the SAP NetWeaver® platform, this market-leading solution is used by top pharmaceuticals to reduce the cost, effort and risk of managing and coordinating global product registrations

Medical Information Management: Protecting Your Patients and Brand Equity

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With a heightened focus on regulatory information compliance, today's medical communications organization has a direct impact on a company's brand equity, customer satisfaction, risk management and ongoing regulatory compliance. As the all-important face of the organization, this is the team who is in direct contact with the public who use, the investigators who monitor, the healthcare professionals who prescribe, and the sales and marketing professionals who promote their products. Regardless of the topic-proper dosage levels, potential effects of drug combinations, reactions and adverse events, off-label use and self-medication-all inquiries need quick, consistent and accurate responses and distribution of information.

Attend a complimentary webcast to learn how your organization can manage the full medical information request-and-response lifecycle to improve customer service levels and streamline business processes. Topics to be covered:

• Facing the challenges: legal and regulatory pressures, increase in misuse of products both on- and off-label, increase in risks and legal liabilities, increase in worldwide product safety and quality concerns, and the need to protect market share and brand equity
• Gaining control over your medical information organization
• Advantages and drawbacks of different solution approaches
• agInquirer™ - Aris Global's comprehensive solution for managing the full medical information request and response lifecycle

Effecting the Paperless Safety Ecosystem

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Driven by growing awareness and interest of the media, consumers and the health care community, annual adverse event (AE) reporting rates to the FDA have more than doubled since 1998. In dealing with information that is received in a variety of structured and unstructured formats from disparate sources, how can a life sciences organization increase quality, efficiency and compliance of adverse event reporting processes?

This one-hour webcast explores strategies and solutions being deployed to contend with the issues of managing incoming AE information and outbound safety reporting in a complex and ever-changing business environment consisting of marketing partners, affiliates and clinical investigators.

Achieving Total Safety - An Overview of Contemporary Safety, Pharmacovigilance & Risk Management Initiatives

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Proactive safety, pharmacovigilance & risk management initiatives require proven technology to effectively meet business objectives.

Explore the strategic technology solutions being deployed by leading pharmaceutical and biotechnology companies in support of Safety, Pharmacovigilance & Risk Management programs.

This one-hour webcast will cover the gamut of Total Safety: adverse event case processing and the safety database; electronic transmission of safety reports to and from authorities; electronic exchange of safety data between partners, affiliates and clinical investigators; data mining, signal detection and analysis; periodic and summary reporting; the potential impact of recent guidance, regulations and legislation.

Gaining Business Value from Data Mining, Signal Detection & Periodic / Summary Reporting

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Data mining and signal detection systems have not lived up to the marketing hype. However, the technology presents opportunities for automating safety, pharmacovigilance and risk management processes if a pragmatic approach is taken.

This one-hour webcast presents information on how companies are moving from investigating such technology to designing, deploying and utilizing data mining and signal detection systems in conjunction with repeatable and sustainable business processes.

Conducting Clinical Trials: New Strategies to Address Today's Challenges

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The lifeblood of a life sciences R&D organization is the successful outcome of clinical research programs. Well-managed clinical trials can ensure a company's long-term success.

Yet the risk of clinical trials failure is greater than ever. Clinical trials pose logistical, operational, financial, technical and many other challenges for trial sponsors and collaborators. They are costly and complex undertakings that require the coordination of many collaborators, patients, physicians, and regulatory agencies.

View the presentation from this one-hour webcast to learn about new strategies to successfully plan, manage and conduct global clinical trials.

The Cost of Compliance Failure: Overcoming the Organizational Gaps

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With every product recall and market withdrawal, companies are becoming painfully aware of increasing information gaps between regulatory affairs and other areas of the company, such as manufacturing, safety, sales and marketing. Good practice and marketing authorizations require each affiliate, manufacturing plant and department to be working from exactly the same approved data to reduce the risk of compliance failures. Surprisingly, this is often not the case.

This a complimentary, one-hour webcast showcases a proven strategy to better ensure global product portfolio management in the face of ever-changing regulatory initiatives.