The Reporting Clock is Ticking - Meeting Regulatory Expectations with the Collection and Processing of Adverse Events

Join this complimentary webcast to learn about the regulatory expectations and typical inspection findings around the quality and completeness of adverse event data collection including timely processing, reconciliation between locations and systems, and retention of source documents. You will also learn how your organization can significantly enhance compliance and operational efficiencies associated with these expectations by leveraging pharmacovigilance and clinical safety automation tools.

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Aris Global Total Regulatory - Going beyond Mere Compliance

Please join Wim Cypers, VP - Regulatory Affairs for an overview of the new XEVMPD, the first major step towards adoption of ISO IDMP standards in 2015-16. Given the scope and a clear three-year timeline associated with the biggest Regulatory Affairs change in over a decade, the rapidly globalising Indian pharmaceutical industry is going to need not only compliant but 'future-ready' IT applications to stay on top of the game.

Wim will also discuss and answer questions on how Aris Global's state-of-the-art Regulatory Affairs solutions - Register™ and agXchange RSM™ - can help you. These solutions are delivered via the proven, cost- and time-effective on-demand agOnDemand™ platform. They manage the end-to-end regulatory submissions and tracking process at low cost, with ease of operation while improving process efficiencies that give you an unbeatable strategic advantage.

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Pharmacovigilance & Safety

Leveraging Technology to Facilitate a More Efficient Safety Reporting Process

In May 2010, Aris Global and Medidata announced the availability of an integrated solution that provides rapid data-sharing between the Medidata Rave® system for electronic data capture, management and reporting and ARISg. While Aris Global offers agCapture™, a proven EDC solution, we also see the value in giving customers the opportunity to leverage the Medidata Rave Safety Gateway to address their critical business challenges. The combined use of ARISg and Medidata Rave, leveraging Rave Safety Gateway, addresses the time-sensitive and safety-critical process of alerting regulatory agencies to potential safety events and offers significant advantages to pharmacovigilance teams. View this webinar to earn how you can benefit from new approaches in collecting and transmitting SAE data from sites to safety systems, designed to improve the efficiency of your clinical safety reporting process. This webinar is jointly presented by Medidata Solutions and Aris Global®.

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Preparing for the Development Safety Update Report (DSUR)

The Development Safety Update Report (DSUR) proposed in the ICH E2F (Step 4) guideline is intended to be a common standard for periodic reporting on drugs under development among the ICH regions. Currently in step 5 of the ICH process, it has been adopted by European regulatory authorities, and will be the required format from September 1, 2011 onwards. View this on demand webcast to understand the broader impact of the regulation on periodic clinical report preparation process, and the best practices for complying with the DSUR.

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Review of the New Regulatory Framework in the European Union

The regulations in the European Union keep evolving at a fast clip. View this on demand webcast to review the implications of the new regulatory framework in the EU.

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Understanding the Impact of the New FDA Requirements for Monitoring Clinical Trial Safety

In September last year, FDA issued a final rule revising the safety reporting requirements for products in clinical trials, with the intent of improving the quality of safety reporting and strengthening their ability to detect signals and improve their safety monitoring capability. View this webcast to understand the impact of this regulation on your departments and processes, and the possible next steps for planning compliance with the new rule.

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Other Important Regulations: Updates on ICSR Reporting Obligations From Across the Globe; IDMP

While some of the updated regulations will have an immediate impact on the processes used in your departments, there a number of other regulations whose impact will be felt in the coming years. View these webcasts to keep yourself up-to-date with the latest news on these regulations.

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Successful Strategies and Best Practices for Streamlining the Receipt and Submission of Adverse Events

View this webcast presentation to learn about the latest trends and effective practices for inbound receipt and triage and outbound submission tracking and understand how Aris Global's agXchange™ IRT and OST, can help you automate and streamline these critical processes.

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Improving the Consistency of Trial Safety Reporting with Centralized Coding and Dictionary Management

View this webcast presentation to learn how companies can minimize the manual effort required for coding using agEncoder, the centralized coding and dictionary management solution from Aris Global to automate the process.

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agXchange IRT and OST: New Strategies for Automating the Receipt and Submission of Adverse eEvents

View this webcast presentation to learn about the latest trends and effective practices for inbound receipt and triage and outbound submission tracking.

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ARISg 6.2: Improving the Case Processing Life Cycle

View this webcast presentation to learn about the new and leading functionality that facilitates case processing, shortens the time for data entry, reduces the manual exchange of paper and improves compliance.

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Successful Strategies and Best Practices for Receiving and Submitting Adverse Events

View this webcast presentation to learn the latest trends and successful methods for receiving, reporting, and submitting safety cases. Discover how Aris Global's hosted solutions, agXchange IRT and OST, can help you automate and streamline these critical processes.

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agSignals and agComposer : Maximizing Safety and Minimizing Risk

View this webcast presentation 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.

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Optimizing Safety Report Distribution: A 2011 New Year’s Resolution You Can Easily Achieve!

As you strategize for how to better optimize your operations in 2011, this presentation could be one of the best investments you make in your 2011 planning efforts. Explore how you can streamline and eliminate the tedious, manual effort involved once and for all. Learn about agXchange SIR™ (safety-to-investigator reporting), a web-based report distribution system that is the first such system to be designed specifically for the investigator.

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agComposer: Ensuring Efficient and Cost-Effective Compliance to Periodic and Aggregate Reporting Obligations

View this webcast presentation to understand how you can manage your aggregate reporting obligations efficiently and cost effectively. Discover how agComposer facilitates cooperation between various departments involved in the preparation of an aggregate report and streamlines the process of periodic report generation utilizing its flexible scheduling and workflow capabilities and advanced report template management features.

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Global Regulatory Update - November 2010
View archived presentation
New international regulations, changes to existing regulations, multiple regulatory agencies -- the abundance of new information can be daunting to track and make sense of. Ignoring these changes can be costly to you, your drug development efforts and marketing programs if you aren't prepared. In this complimentary 45-minute webcast, Mark Loudon Aris Global's director, regulatory compliance, discusses key regulatory announcements and their impact on the life science industry. This information packed webinar will help you sift through the merely interesting developments to find those that are truly important to your organization.

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Regulatory Affairs

EVMPD – Set Sail

Continuing the series of webcasts on the new EVMPD regulation, Wim Cypers, VP Regulatory Affairs, discussed the increased scope of the regulation due to structured substance information (SSI) in the third webcast titled 'EVMPD - Set Sail' on November 16, 2011.

With our state-of-the-art solutions - Register™ and agXchange RSM™ - you can address this challenge at low cost, with ease of operation while improving your regulatory affairs processes. Register is a market-leading solution for regulatory information management; agXchange RSM is a proven solution for EVMPD-compliant submissions.

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EVMPD – Riding the Wave

Following on the discussion during our first webcast on EVMPD titled Navigating in the Winds of Change, during this second webcast in the EVMPD series, Wim Cypers, VP Regulatory Affairs SPU, discussed the scope and tight deadline associated with these regulatory changes Aris Global can help you manage and address this challenge.

With our state-of-the-art solutions Register™ and agXchange RSM™ - you can do this at low cost, with ease of operation while improving your regulatory affairs processes. Register is a market-leading solution for regulatory information management; agXchange RSM is a proven solution for EVMPD-compliant submissions.

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Single Source of Authoritative Data: Eliminating Manual and Redundant Regulatory Tracking

View this webcast presentation and look at how companies can make better and more informed business decisions while lowering the costs for tracking regulatory submissions and monitoring obligations with regulatory authorities.

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Beyond SPL R4 Compliance: Achieving Operational Efficiencies in Regulatory & Labeling

View this webcast to learn how industry leaders Aris Global and i4i (Infrastructure for Information) help companies achieve compliance while realizing operational efficiencies for an end-to-end label management and registration tracking solution.

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Register 5.1: Leading the Way in Tracking Post-Marketing Commitments

View this presentation to learn how Register overcomes the challenges of tracking and managing commitments and obligations that can lead to critical compliance and registrations issues if not initiated or completed on a timely basis.

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Register 5: Automating the Tracking of Regulatory Submissions

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.

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Regulatory and Manufacturing: A Strategy for Bridging the Compliance Gap

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.

View this webcast presentation to learn about a proven strategy that better ensures global product portfolio management.

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EVMPD - Navigating in the Winds of Change

EMA has recently announced that it will be implementing a new set of EVMPD regulations. These are expected to come into effect from July 02, 2011 onwards. View this webcast and learn how Register and agXchange RSM will help you navigate this major regulatory change at low cost, with ease of operation bringing about process improvements.

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Medical Information

Medical Information Management: Protecting Your Patients and Brand Equity

With an increased 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.
View this archived presentation to learn how your organization can manage the full medical information request-and-response lifecycle to improve customer service levels and streamline business processes.

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Clinical Research and Operations

Total Clinical: The Many Benefits of Integrating with Safety and Clinical Systems

Total Clinical delivers a level of integration that is smart, meaningful and value added - finally delivering seamless interoperability across clinical systems. Attend this webcast to hear about a best-in-class suite of clinical safety, EDC, coding and CTMS applications that truly deliver on the "enter data once & share across the enterprise" promise.

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agCapture: Integration with Oracle Clinical

Oracle Clinical is the CDMS platform of choice for many companies. Attend this webcast to understand how agCapture can be used to automatically export EDC data into Oracle Clinical, to give your organization a single repository where all your clinical trials data can be stored.

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agCapture: Improving Trial Outcome with Integrated Decision Support

Imagine what can be achieved if, according to your study protocol, your EDC could automatically adjust dosing schedules based on the clinical data of each individual trial subject. Attend this webcast to learn how agCapture is integrated with award-winning decision support technology that provides integrated protocol guidance help to investigators to ensure the "right treatment for the right patient" and provides investigators with real-time advice and best practice guidelines.

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Clinical Operations: Best Practices for Automating Safety-to-Investigator Reporting

Learn the latest trends and successful methods for distributing clinical safety reports and other clinical documentation to investigators, IRBs, ethics committees and other stakeholders. receiving, reporting, and submitting safety cases. Discover how Aris Global's hosted solution, agXchange SIR , can automate and streamline safety report distribution while delivering significant cost saving, efficiencies, and better compliance.

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agXchange SIR: Safety Report Distribution - Overhauling a Time-Critical Responsibility

Learn about the challenges of managing safety-to-investigator report distribution and how agXchange SIR, the hosted software-as-a-service solution from Aris Global, can overhaul a manual, costly and time-intensive nightmare into an automated report distribution process that delivers a quick return on your investment and improves compliance.

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Optimizing Safety Report Distribution: A 2011 New Year’s Resolution You Can Easily Achieve!

As you strategize for how to better optimize your operations in 2011, this presentation could be one of the best investments you make in your 2011 planning efforts. Explore how you can streamline and eliminate the tedious, manual effort involved once and for all. Learn about agXchange SIR™ (safety-to-investigator reporting), a web-based report distribution system that is the first such system to be designed specifically for the investigator.

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Hosted, Managed Software

Hosted Drug Safety: Removing the Barriers of Cost, Complexity and Constraints

Explore the cost savings and compliance benefits that a growing number of companies are experiencing with agOnDemand , the hosted drug safety system from Aris Global®. You will learn about the Molecular Insight Pharmaceuticals case study and the Switch-to-Save program underway that can deliver a fully validated, highly secure system in less than 5 weeks.

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Hosted Drug Safety & Outsourced Case Processing: Your One-Stop, Cost-Effective Solution for Achieving Safety Control

Attend this webcast to learn how companies are able to achieve significant cost savings as they now can focus on their core safety and business activities while meeting regulatory obligations.

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Hosted Regulatory Tracking: Managing Regulatory Obligations with Greater Speed and Efficiency

Attend this webcast to learn about agOnDemand RT , hosted software for cost-effectively automating the tracking and managing of all regulatory affairs activities on a global basis.

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Currently there are no regional seminars scheduled. Please check back soon for any updates.