Navigation Links
Drug Safety & Risk Management, New Webinar Hosted by Xtalks
Date:6/6/2013

Toronto, Canada (PRWEB) June 06, 2013

Pharmaceutical companies are making great efforts to ensure the safe use of medication through product labeling, risk management and post-marketing safety surveillance.

In the fall of 2007, Congress passed the FDA Amendments Act (FDAAA), mandating FDA to establish an active surveillance system for monitoring drugs, using electronic data from healthcare information holders. Its goal is to build and implement a new active surveillance system that will eventually be used to monitor all FDA-regulated products.

This webinar will discuss the new European Union (EU) Pharmacovigilance legislation to ensure compliance and evaluate the optimal risk management plan (RMP), Risk Evaluation, and Mitigation Strategies (REMS) for EU and US submissions.

Periodic-Benefit Risk Evaluation report, PBRER represents a significant change from the previous format and has a taken a quantum leap forward towards a document incorporating many new concepts including an integrated evaluation of both benefits and risks of a medicinal product. How to implement the PBRER to encompass multiple functions will also be discussed in this session.

Topics to be covered:

  •     Risk Management for Pharmaceutical Products
  •     Risk Management Cycle
  •     New EU Pharmacovigilance Legislation
  •     RMP and REMS
  •     Leap from PSURs to Benefit Risk Evaluation (PBRERs)

A live Q&A with the audience will follow the main presentation.

For more information, or to register for this event please go to http://xtalks.com/drug-safety-risk-management.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 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:
Zayeeta Dasgupta, M.Sc in Life Science and Business Management
1- (416) 977-6555 ext. 260

Read the full story at http://www.prweb.com/releases/2013/6/prweb10785633.htm.


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

Related biology technology :

1. Amgen Presents Final Results from the Largest Phase 3 Open-Label Study Assessing the Safety and Efficacy of Nplate® (Romiplostim)
2. New measuring techniques can improve efficiency, safety of nanoparticles
3. Interim Clinical Trial Results Confirm Safety of Renadyl™, a Probiotic Dietary Supplement for the Support of Healthy Kidney Function
4. Targeted antibacterial agent rapidly created in response to serious food safety pathogen
5. Notre Dame paper examines nanotechnology-related safety and ethics problem
6. New Revolutionary Femoral Access Site Closure Device Shows Unparalleled Efficacy, Safety & Ease of Use, in a Wide Range of Patients Including Patients With a Challenging Anatomy
7. Alliance for Safe Biologic Medicines Chairman Urges FDA to Ensure that Patient Safety is the Cornerstone of Biosimilar Pathway
8. OrbusNeichs Combo Dual Therapy Stent™ Demonstrates Favorable Clinical and Safety Outcomes at 12-Month Follow-Up
9. Sangart Raises Additional $50M Series G Funding Following Interim Safety Analysis Of Phase 2b Study Of MP4OX In Severe Trauma Patients With Hemorrhagic Shock
10. New Epidemiological Data Provide Additional Safety Evidence for Lantus®
11. Produce Safety Researchers Awarded by ABC Research Laboratories
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... Calif., March 23, 2017  BioPharmX Corporation (NYSE ... for the dermatology market, today reported financial results ... 2017, and will provide an update on the ... year. "We are pleased to report ... for BioPharmX," said President Anja Krammer. "We achieved ...
(Date:3/23/2017)... VILLAGE, Colo. , March 23, 2017  Agriculture ... in Series A financing and note conversion to commercialize ... Cool Planet is focused on developing products that are ... nearly $30 million in the last 18 months. This ... and North Bridge Venture Partners. The ...
(Date:3/22/2017)...  Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical ... address significant unmet medical needs in rare diseases, ... ended December 31, 2016. "2016 ... we broadened our pipeline and pursued our vision ... with an initial focus on endocrinology," said ...
(Date:3/22/2017)... 2017 The global chronic kidney ... report by Transparency Market Research (TMR). The top four ... AbbVie Inc., accounted for a share of only 41.4% ... this market are focusing aggressively on mergers, acquisitions, and ... likely to lead to market consolidation in the next ...
Breaking Biology Technology:
(Date:3/20/2017)... , March 20, 2017 PMD Healthcare announces ... spirometer and Wellness Management System (WMS), a remote, real-time ... in 2010, PMD Healthcare is a Medical Device, Digital ... mission dedicated to creating innovative solutions that empower people ... that intent focus, PMD developed the first ever personal ...
(Date:3/9/2017)... and MOUNTAIN VIEW, Calif. , ... Well Made Simple," and 23andMe , the leading ... better food choices.  Zipongo can now provide customers with ... preferences, health goals and biometrics, but also genetic markers ... choices. Zipongo,s personalized food decision support platform ...
(Date:3/2/2017)... Summary This report provides all the ... interests and activities since 2010. ... Read the full report: http://www.reportlinker.com/p03605615-summary/view-report.html ... report provides an in-depth insight into the partnering activity of ... On demand company reports are prepared upon purchase to ensure ...
Breaking Biology News(10 mins):