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:9/21/2017)... (PRWEB) , ... September 21, 2017 , ... ... HQ office, which includes executive, engineering and manufacturing functions to The LaunchPort™ Accelerator ... The Factory™, provide a full range of manufacturing and business services to its ...
(Date:9/21/2017)... ... September 21, 2017 , ... ... research sector professionals, has announced the addition of 5 new courses to its ... - Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic ...
(Date:9/20/2017)... New Haven, CT (PRWEB) , ... September 20, ... ... therapeutics company, announced today that it has appointed Vishwas Paralkar to the role ... of Cybrexa’s tumor targeting technology. He will report to Cybrexa’s president and CEO, ...
(Date:9/20/2017)... Texas (PRWEB) , ... September 20, 2017 , ... From ... cell therapy succeeded after standard medicine failed. Many of these people had lost all ... Not Regression Free Download (pdf) , “Neil takes readers ...
Breaking Biology Technology:
(Date:3/30/2017)... March 30, 2017  On April 6-7, 2017, Sequencing.com ... Genome hackathon at Microsoft,s headquarters in ... will focus on developing health and wellness apps that ... Hack the Genome is the first hackathon for ... world,s largest companies in the genomics, tech and health ...
(Date:3/28/2017)... March 28, 2017 The report ... (Camera, Monitors, Servers, Storage Devices), Software (Video Analytics, VMS), ... - Global Forecast to 2022", published by MarketsandMarkets, the ... and is projected to reach USD 75.64 Billion by ... 2022. The base year considered for the study is ...
(Date:3/23/2017)... , March 23, 2017 The report "Gesture Recognition and ... Industry, and Geography - Global Forecast to 2022", published by MarketsandMarkets, the market ... CAGR of 29.63% between 2017 and 2022. Continue ... ... ...
Breaking Biology News(10 mins):