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Posts tagged with "pharmacovigilance system"

MIGRATING FROM ORACLE AERS TO ARGUS SAFETY: THE REASONS FOR THE MOVE

by Eugene Sefanov

Not too long ago, Oracle AERS was the most widely-used adverse event report system. However, with the acquisition of Relsys and its safety and pharmacovigilance system in 2009, Argus Safety quickly became the go-to software for most life sciences companies. Its capabilities and comprehensiveness simply were, and continues to be, unmatched.

Companies currently using Oracle AERS have expressed interest in moving to Argus Safety, but want to know more before making the jump. This webinar is meant to do just that – answer your common questions.

Please join BioPharm’s Dr. Rodney Lemery, VP of safety and pharmacovigilance, for a free one-hour webinar in which he will:

  • Compare Argus Safety to AERS
  • Cover the options of effectively migrating to Argus Safety

Register to view the webinar: https://cc.readytalk.com/r/797ko39igeyx&eom

For more information about BioPharm Systems, please visit www.biopharm.com.

MIGRATING FROM EMPIRICA TRACE TO ARGUS SAFETY: THE REASONS FOR THE MOVE

by Eugene Sefanov

Oracle added Empirica Trace to its product portfolio when it acquired Phase Forward in 2010. Although the safety database has successfully helped organizations meet their requirements over the years, it lacks many user-friendly features and the deep functionality that is essential in today’s highly-regulated environment. Whether the capabilities relate to system management, coding, E2B, languages, or reporting, there are many differentiators in Argus Safety that current Empirca Trace users will be able to appreciate.

Please join BioPharm’s Dr. Rodney Lemery, VP of safety and pharmacovigilance, for a free one-hour webinar in which he will:

  • Compare Argus Safety to Empirica Trace
  • Cover the options of effectively migrating to Argus Safety

Register to view the webinar: https://cc.readytalk.com/r/73vghet75yx8&eom

For more information about BioPharm Systems, please visit www.biopharm.com.

Feb 6
Top Pharmacovigilance and Drug Safety System Migration Challenges

Top Pharmacovigilance and Drug Safety System Migration Challenges

Learn more about signal management, the process of detecting, prioritizing and evaluating determined signals in a data population. This infographic also mentions signal detection, signal prioritization, and signal evaluation.

Learn more about signal management, the process of detecting, prioritizing and evaluating determined signals in a data population. This infographic also mentions signal detection, signal prioritization, and signal evaluation.

May 6

FREE WEBINAR: STREAMLINING A GLOBAL LIFE SCIENCES COMPANY’S PHARMACOVIGILANCE OPERATIONS

by Eugene Sefanov

As the focus on international product safety regulations increases, life sciences organizations must globalize and enhance their safety and pharmacovigilance operations in order to successfully navigate through the challenges they are presented with.

Join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for this free one-hour webinar that will discuss a major pharmaceutical company’s pharmacovigilance globalization initiative that helped standardize and streamline its operations.

Several topics that will be discussed include:

  • SOP Integration
  • Standardization of Local Practices
  • Departmental Coordination
  • Varying Reporting Requirements

Register to view the webinar at https://cc.readytalk.com/r/14um1yqp5jps.

For more information about BioPharm Systems, please visit www.biopharm.com.

FREE WEBINAR: MERGING MULTIPLE DRUG SAFETY AND PHARMACOVIGILANCE DATABASES INTO ONE GLOBAL ORACLE ARGUS SAFETY SYSTEM

by Eugene Sefanov

Many sponsors and CROs rely on an IT infrastructure that includes multiple disconnected safety and pharmacovigilance systems that vary by region and vendor. Although merging these systems into a single global solution may seem daunting and provide you with many technical challenges, it could be a crucial goal on the horizon for your organization.

Please join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for this free one-hour webinar in which he will review a recent project for a top pharmaceutical company that entailed the merging of multiple drug safety systems into one global Argus Safety pharmacovigilance system. 

Specific topics that will be examined include:

  • Adverse Event Case Migration
  • Merging and Configuring
  • Data Cleansing and Consistency
  • Configuring Reporting Rules

Register to view the webinar at https://cc.readytalk.com/r/nu2vem0xprkr.

For more information about BioPharm Systems, please visit www.biopharm.com

Using Oracle’s Empirica Topics to Document Your Signal Management Process

by Eugene Sefanov

Signal management, the detection, prioritization, and evaluation of signals, is a crucial activity that life sciences organizations should continuously perform in an effort to ensure their products are not related to excessive risks in relationship to the products’ benefits. With the emergence of comprehensive and user-friendly signal management solutions, the management of signals has become easier and more effective.

Oracle’s Empirica Topics is a powerful tool that helps companies track information and activities that are related to potential safety and pharmacovigilance signals. For example, after the creation of a signal topic, it can be delegated to members of a safety team for documenting the prioritization and evaluation of the signal. This transparent and collaborative process can protect your organization in an audit and ensure you have a well-established methodology for signal management.

Join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for this free one-hour webinar that will explore why and how Empirica Topics can be:

  • Implemented and configured using BioPharm’s unique methodology
  • Utilized to strengthen your pharmacovigilance systems and processes, by employing techniques promoted by the Council for International Organizations of Medical Sciences (CIOMS) Working Group VIII

Register to view the webinar at https://cc.readytalk.com/r/wjvsun6v20rp.

For more information about BioPharm Systems, please visit www.biopharm.com.

FREE WEBINAR: BUSINESS AND OPERATIONAL RISKS IN CLINICAL AND SAFETY: APPLYING APPROPRIATE TECHNOLOGY AND APPROACHES TO MITIGATE RISK

by Eugene Sefanov

All business processes are subject to some level of risk. Key to the long term viability of any company is the critical need to identify the risks, quantify them, minimize them, and have a clear plan for dealing with any residual risks.

Organizations try to mitigate risks by implementing systems that support the company’s business processes. Commercial software systems that are available from vendors such as Oracle include many capabilities which, if implemented properly, greatly reduce the risks in the business process.

The implementation of complex systems is, in itself, a risky process. Organizations like BioPharm Systems have been able to use their wide range of experience to develop pre-configured and pre-validated solutions that help reduce the risks during the implementation of a clinical trial management system (CTMS) and a safety system.

This one and a half-hour webinar will provide an overview of business risks related to clinical and safety systems and will illustrate how the risks inherent in implementing complex CTMS and safety systems can be significantly reduced.

View a recording of the webinar at https://cc.readytalk.com/r/9ho7q3hcfcbr.

For more information about BioPharm Systems, please visit www.biopharm.com

Oct 7

Free Webinar: Argus Safety: Planning for the New Individual Case Safety Report (ICSR) International Standard and Upcoming ICSR Reporting Changes

by Eugene Sefanov

The new ISO Individual Case Safety Report (ICSR) standard is being finalized in 2011. A major revision of the ICH E2B guideline is progressing based on the new ICSR standard with an ICH step 2 consultation of the ICH E2B(R3) Implementation Guide expected by the end of June 2011. An overview of the proposed changes to the ICSR Final Draft International Standard (FDIS) and its implementation will be discussed, along with the expected changes to the ICSR reporting in the context of the new European pharmacovigilance legislation.

Join BioPharm Systems’ Andrew Mitchell, EMEA safety and pharmacovigilance practice lead, for this one-hour presentation that will include:

  • Discussion of the upcoming ISO Individual Case Safety Report (ICSR) standard known as ICH E2B(R3)
  • Electronic reporting of ICSRs and EudraVigilance in the context of the new European pharmacovigilance legislation
  • Using Argus Safety to comply with the information and regulations above and how this affects your upgrade planning

View a recording of the webinar at https://cc.readytalk.com/r/1arwmwvagd2p.

For more information about BioPharm Systems, please visit www.biopharm.com.

Oct 7

Free Webinar: Oracle Argus Safety and Oracle Argus Safety Japan: A Unified Solution that Facilitates Compliant Reporting to a Japanese Regulator

by Eugene Sefanov

Achieving complete and efficient reporting of adverse drug reactions is a critical goal for all companies involved in developing and delivering medicinal products to the world’s population. These companies include pharmaceutical, biotech, medical device, contract research organizations (CROs), charitable and not-for-profit organizations and academic institutions.

While the challenge of efficient and effective safety reporting to two of the major regulatory agencies – FDA and EMA – is substantial, the additional challenge of reporting to the Japanese regulatory authority, the PMDA, in a way that integrates with an existing safety reporting process and function is significantly greater.

Argus Safety and Argus Safety Japan together help you to meet these challenges by providing a single global database and integrated workflow process for superior safety reporting capabilities.

This webinar will be of interest and relevance to all organizations that need a robust and proven safety system to meet their global regulatory reporting requirements. It will be of particular interest to those companies that have a requirement to report safety events to the PDMA in Japan in a timely and efficient manner that is integrated within their global safety reporting functions. 

This webinar will provide you with:

  • An overview and the business benefits of Oracle Argus Safety Suite
  • The business benefits of Oracle Argus Safety Japan and integrating it with Oracle Argus Safety
  • The benefits of a single global safety database and why Oracle Argus Safety Suite is the right solution for it

Tuesday, September 13, 2011 @:

7:00 a.m. US Pacific time
8:00 a.m. US Mountain time
9:00 a.m. US Central time
10:00 a.m. US Eastern time
15:00 UK time
16:00 Central European time

View a recording of the webinar at https://cc.readytalk.com/r/m2u0hnfh8pnm. 

For more information about BioPharm Systems, please visit www.biopharm.com.