Navigation Links
Pharmacovigilance Benefit-Risk Assessments: Requirements, Transparency, and Implications, a New and Upcoming Drug Safety Webinar Hosted by Xtalks
Date:11/26/2013

Toronto, Canada (PRWEB) November 26, 2013

Pharmacovigilance Benefit-risk assessments are typically conducted as part of a regulatory inquiry, for completing the PBRER, the RMP, or as part of an NDA submission. However, benefit-risk assessments are also a crucial part of signal validation and due diligence for making portfolio decisions. This webinar will outline the methodology and conduct of safety benefit-risk assessments for post-marketed products.

There are currently several challenges for companies trying to meet the requirements for benefit-risk assessments. The methodology for identifying and calculating risks and their frequencies in the post-marketing phase is subject to different, varying factors and fraught with caveats. At the end of the day, measuring and defining benefit-risk for a specific product is subjective.

This webinar will look at the challenges of conducting benefit-risk assessments at both the portfolio and the product-level to:

  • Provide an overview of regulations in the EU and the US requiring benefit-risk assessments
  • Determine how to increase transparency with agencies and other stakeholders and discuss why transparency is important
  • Examine the consequences of incorrectly assessing benefit and risk

Join keynote speaker Mary Mease, Senior Director of Risk Management at Quintiles, to learn:

  • General guidelines for conducting benefit-risk assessments
  • Understand regulatory requirements around benefit-risk assessments

Mary Mease leads the Safety Knowledge Team, the business strategy for Lifecycle Safety, and the development of strategies and solutions for Risk Evaluation and Mitigation Strategies (REMS) at Quintiles.

For more information on this webinar or to register, visit: http://xtalks.com/Pharmacovigilance-Benefit-Risk-Assessments.ashx

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks, visit http://xtalks.com/ContactUs.ashx.

Contact:
Michelle Tran (416) 977-6555 ext 227
clientservices(at)xtalks(dot)com

Read the full story at http://www.prweb.com/releases/2013/11/prweb11363251.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. PRA Expert to Present at Pharmacovigilance Conference
2. How to Ensure Pharmacovigilance Practices are Compliant with Global Safety Requirements: Challenges in Asia-Pacific
3. New Life Science Webinar Hosted by Xtalks Examines Outsourcing in Pharmacovigilance
4. Pharmacovigilance: ADR Management and Reporting & Outsourcing Trends, A New Drug Safety Webinar from Xtalks
5. Keryx Biopharmaceuticals, Inc. Announces Upcoming Poster Presentations of Zerenex™ (Ferric Citrate) at the Upcoming American Society of Nephrology Kidney Week 2011 Annual Meeting
6. Leaders in Science Join Upcoming Celebration of the 100th Anniversary of the Oldest Science Foundation in America
7. Cardium to Present at Upcoming Investor Conferences
8. Life Technologies to Present at Upcoming Investment Conferences in February
9. Cepheid to Webcast Upcoming Financial Presentations
10. Ambit Biosciences to Present at Two Upcoming Investor Conferences
11. Orexigen Therapeutics to Present at Upcoming Conferences
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 24, 2016  Regular discussions on a range of subjects ... the two entities said Poloz. Speaking at a ... , he pointed to the country,s inflation target, which ... "In certain areas ... have common economic goals, why not sit down and address ...
(Date:6/23/2016)... , ... June 23, 2016 , ... ... release of its second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” Partnering ... retention in this eBook by providing practical tips, tools, and strategies for clinical ...
(Date:6/23/2016)... Md. , June 23, 2016 A person ... from the crime scene to track the criminal down. ... the U.S. Food and Drug Administration (FDA) uses DNA evidence ... Sound far-fetched? It,s not. The FDA ... sequencing to support investigations of foodborne illnesses. Put as simply ...
(Date:6/23/2016)... NEW YORK , June, 23, 2016  The ... students to envision new ways to harness living systems ... of Modern Art (MoMA) in New York ... more than 130 participating students, showcased projects at MoMA,s ... included Paola Antonelli , MoMA,s senior curator of ...
Breaking Biology Technology:
(Date:6/20/2016)... , June 20, 2016 Securus ... justice technology solutions for public safety, investigation, corrections ... the prisons involved, it has secured the final ... (DOC) facilities for Managed Access Systems (MAS) installed. ... additional facilities to be installed by October, 2016. ...
(Date:6/15/2016)... , June 15, 2016 ... report titled "Gesture Recognition Market by Application Market - Global Industry ... - 2024". According to the report, the  global gesture ... in 2015 and is estimated to grow at ... billion by 2024.  Increasing application of ...
(Date:6/9/2016)... TURKU, Finland , June 9, 2016 ... French National Police deploy Teleste,s video security solution to ensure ... France during the major tournament ... and data communications systems and services, announced today that its ... Police Prefecture to back up public safety across ...
Breaking Biology News(10 mins):