Navigation Links
How to Ensure Pharmacovigilance Practices are Compliant with Global Safety Requirements: Challenges in Asia-Pacific
Date:1/21/2013

Toronto, Canada (PRWEB) January 21, 2013

National Regulators enact various Pharmacovigilance (PV) regulations in order to ensure that medicines and medical devices are acceptably safe. The regulations and guidelines from the Council for International Organizations of Medical Sciences (CIOMS) and the International Conference on Harmonisation (ICH) guide how pharmaceutical companies manage day-to-day PV activities. Although PV activities such as handling Individual Case Safety Reports (ICSRs), writing Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) are standard processes managed by pharmaceutical companies, the way such activities are regulated by various Regulators is not always harmonized. Requirements and timelines can vary greatly amongst Regulators and are not always consistent with International Standards. As a result, pharmaceutical companies need to ensure they comply with the various requirements and timelines from international Regulators.

Key Discussion Points:

  •     PV Challenges in Asia
  •     Setting up a Local Office to act as the go between Global Headquarters and the Local Heath Authority
  •     Comparing Global Standards to Local Standards, including examples highlighting different ways companies can use to adopt both at HQ and Locally to meet at the regulations
  •     Ensuring compliance locally: How global companies can monitor their offices worldwide to ensure compliance with both local requirements, company requirements and global standards

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://xtks.in/xto557p.

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:
Karen Lim (416) 977-6555 ext 227
clientservices(at)xtalks(dot)com

Read the full story at http://www.prweb.com/releases/2013/1/prweb10286784.htm.


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

Related biology technology :

1. Alliance for Safe Biologic Medicines Chairman Urges FDA to Ensure that Patient Safety is the Cornerstone of Biosimilar Pathway
2. Scholars call for global governance overhaul to ensure Earths sustainability
3. PRA Expert to Present at Pharmacovigilance Conference
4. First Suit Against Nobel Prize Organization Citing Defamation And Unfair Competition Practices Is Filed
5. Best Practices, LLC Issues New Report and Webinar on Managing Healthcare Reform through Effective Engagement with the Government Ecosystem
6. Reno Efficient Sustainable Practices Selected to Provide Water and Energy Conservation Services To the County of San Diego
7. Innovation Leaders from Across Industries will Convene to Share Best Practices and Breakthrough Successes at Open Innovation Leadership Summit
8. PAREXEL Introduces Executive Briefing Series on Proven Practices to Assist Emerging and Mid-size Biopharma in Achieving Better Outcomes
9. CSL Behring enrolls first patient in global pediatric Phase III pivotal study of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) to treat hemophilia B
10. Lucintel’s Analysis of Global Base Metal Mining Industry: Market to Reach $305 Billion in 2017
11. Global Metabolomics Market Reviewed & Forecast in New In-Demand Report Available at MarketPublishers.com
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... June 27, 2016  Global demand for enzymes ... through 2020 to $7.2 billion.  This market includes ... cleaning products, biofuel production, animal feed, and other ... and biocatalysts). Food and beverages will remain the ... increasing consumption of products containing enzymes in developing ...
(Date:6/27/2016)... CA (PRWEB) , ... June 27, 2016 , ... ... for clinical trials, announced today the Clinical Reach Virtual Patient Encounter CONSULT ... care circle with the physician and clinical trial team. , Using the CONSULT module, ...
(Date:6/27/2016)... 27, 2016   Ginkgo Bioworks , a leading ... was today awarded as one of the World ... world,s most innovative companies. Ginkgo Bioworks is engineering ... real world in the nutrition, health and consumer ... with customers including Fortune 500 companies to design ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Researchers at ... most commonly-identified miRNAs in people with peritoneal or pleural mesothelioma. Their findings are the ... read it now. , Diagnostic biomarkers are signposts in the blood, lung fluid ...
Breaking Biology Technology:
(Date:6/16/2016)... 16, 2016 The global ... to reach USD 1.83 billion by 2024, according ... Inc. Technological proliferation and increasing demand in commercial ... to drive the market growth.      ... The development of advanced multimodal techniques for biometric ...
(Date:6/7/2016)... , June 7, 2016  Syngrafii Inc. ... a business relationship that includes integrating Syngrafii,s patented ... branch project. This collaboration will result in greater ... the credit union, while maintaining existing document workflow ... http://photos.prnewswire.com/prnh/20160606/375871LOGO ...
(Date:6/2/2016)... Perimeter Surveillance & Detection Systems, ... Infrastructure, Support & Other Service  The latest ... comprehensive analysis of the global Border Security market ... of $17.98 billion in 2016. Now: In ... in software and hardware technologies for advanced video surveillance. ...
Breaking Biology News(10 mins):