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:

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2

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:4/17/2015)... Madison, WI (PRWEB) April 17, 2015 ... provide sales and marketing support for the powerful ... at the Chemical Genomics Center at the Lankenau ... LCGC’s mission is to measurably improve successful ... to HTS, by offering rare, drug-like libraries available ...
(Date:4/16/2015)... CAMBRIDGE, Mass. (PRWEB) April 16, 2015 ... of smart data solutions driven by Semantic Web ... provider of specialist information and services for the ... today announced that its joint solution ‘Smart Data ... named a finalist for the 2015 Bio-IT ‘Best ...
(Date:4/16/2015)... Irvine, CA (PRWEB) April 16, 2015 ... in the Buzz of BIO Contest for ... Industry Organization (BIO), the 2015 BIO International Convention will ... in Philadelphia, Pennsylvania. During the Buzz of BIO contest, ... like to see present at the conference. The community ...
(Date:4/16/2015)... According to the 2014 Liberty Mutual ... was ranked first among the leading causes of ... pushing, pulling, holding, carrying, or throwing and cost ... Round Company takes statistics like this very seriously. ... develop and design equipment that prevents these injuries ...
Breaking Biology Technology:BellBrook Labs and Lankenau Institute Partner to Accelerate Drug Discovery using Orthogonal Pooled Screening 2Cambridge Semantics and Informa Named Bio-IT Award Finalist for Smart Data Lake Solution for Clinical Trial and Competitive Intelligence 2Cambridge Semantics and Informa Named Bio-IT Award Finalist for Smart Data Lake Solution for Clinical Trial and Competitive Intelligence 3Proove Bisociences to Participate in the Buzz of BIO at the 2015 BIO International Convention 2Proove Bisociences to Participate in the Buzz of BIO at the 2015 BIO International Convention 3The David Round Company Helps Companies Meet OSHA Standards by Combining Safety, Ergonomics, and Productivity 2
... 7 /PRNewswire-FirstCall/ - ARIUS Research Inc., (TSX:,ARI), a ... of,antibody therapeutics, today announced that it will deliver ... for,two of its anti-cancer antibody drug candidates. ... Francisco on September 7-8,Arius will report recent results ...
... Announces ofatumumab Appeared More Effective Than rituximab ... ... Genmab A/S,(OMX: GEN) announced today that ofatumumab (HuMax-CD20(R)) appeared more,effective ... than rituximab in a pre-clinical study. The CD20,antibodies were incubated ...
... Feynman presented a talk entitled There,s Plenty of Room at ... reason why humans couldn,t manipulate atoms. However, if atomic ... positions remains. How do you know what you have ... of Science, IBM and Imago have taken a seminal step ...
Cached Biology Technology:Arius Features Preclinical Data on Antibody Candidates at Two Conferences 2Arius Features Preclinical Data on Antibody Candidates at Two Conferences 3Genmab Announces Encouraging Preclinical Data for ofatumumab 2IBM and Imago find a crucial difficulty in semiconductor device scaling 2
(Date:4/14/2015)... Conn. , April 14, 2015 NXT-ID, ... a biometric authentication company focused on the growing mobile ... been nominated for the 2015 New York Design Awards ... The Design100, New York City Design Awards are part ... based on over 2,500 ratings from the marketplace, industry ...
(Date:4/13/2015)... April 13, 2015  higi, a leading cloud-based consumer ... more fully engage with their communities around health and ... protected and secure API.  ... most accessible, affordable, and convenient vehicle to receive validated ... The API will allow higi,s trusted ...
(Date:4/9/2015)... SAN JOSE, Calif. , April 9, 2015 /PRNewswire/ ... of human interface solutions, announced today that it will ... 2015 on Thursday, April 23, 2015, after the close ... call for analysts and investors at 2:00 p.m. PT ... information.    To participate on the live ...
Breaking Biology News(10 mins):NXT-ID's Wocket Smart Wallet Nominated for 2015 New York Design Awards in 'Product Design- Technology' 2NXT-ID's Wocket Smart Wallet Nominated for 2015 New York Design Awards in 'Product Design- Technology' 3higi Launches Seamless Access to HIPAA-Compliant Health Outcomes and Activity Data 2higi Launches Seamless Access to HIPAA-Compliant Health Outcomes and Activity Data 3Synaptics to Report Third Quarter Results on April 23 2
... 2013 -- Resveratrol, a naturally occurring polyphenol compound produced ... found in red wine, has been touted as a ... This has been supported by some experimental studies, whereas ... using two multiple sclerosis (MS) models published in ...
... metabolic pathway for breaking down glucose that could lead to ... The new pathway is intended to replace the ... reactions that nearly all organisms use to convert sugars into ... the six carbon atoms found in glucose into two-carbon molecules ...
... a diverse team of University of Pittsburgh scientists to report ... that they had solved the mystery of a basic ... mechanism by which mitochondria tiny structures inside cells often ... and need to be eliminated, the Pitt team has opened ...
Cached Biology News:Resveratrol, found in red wine, worsens MS-like symptoms and neuropathology in mice 2Resveratrol, found in red wine, worsens MS-like symptoms and neuropathology in mice 3UCLA engineers develop new metabolic pathway to more efficiently convert sugars into biofuels 2When cells 'eat' their own power plants; Pitt scientists solve mystery of cellular process 2When cells 'eat' their own power plants; Pitt scientists solve mystery of cellular process 3
Mouse Endoglin/CD105 Fluorescein MAb (Clone 209701)...
... is an inhibitor of ... concentration of inhibitor required ... must be determined empirically ... micromolar inhibitor is sufficient ...
...
SNARE associated protein snapin, clone MGC:2717...
Biology Products: