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 p
'/>"/>

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

Page: 1 2

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:3/2/2015)... MIAMI (PRWEB) March 02, 2015 ... a newly formed alliance with Shenzhen HANK Bioengineering ... M.D., Ph.D. The alliance will establish a stem ... Guangdong Province, China in September 2015. , Shenzhen ... by Zhang, an award-winning scientist, microbiologist and virologist, ...
(Date:3/1/2015)... 2015 Market Publishers Ltd and ... market research promotion on Internet. MarketPublishers.com is now ... out by DataGroup Booksellers. , Natalie Aster, Assistant ... commented on the recent partnership agreement as follows: ... our team of publishers. Since 1974, the company ...
(Date:2/27/2015)... Scotia (PRWEB) February 27, 2015 Immunovaccine ... made aware of a fraudulent press release disseminated this ... to be from Immunovaccine. This press release states that ... Science, Inc. The press release did not originate ... information contained within the press release. Please note ...
(Date:2/27/2015)... Calif. , Feb. 27, 2015  Pharmacyclics, ... that longer-term toxicology studies for its newly developed ... or RA, have been completed. The results of ... U.S. Food and Drug Administration. The feedback received ... of the ongoing first-in-human study. Additional preclinical work ...
Breaking Biology Technology:Global Stem Cells Group Announces Alliance with HANK Bioengineering Co., Ltd. in Shenzhen, China 2Global Stem Cells Group Announces Alliance with HANK Bioengineering Co., Ltd. in Shenzhen, China 3Market Publishers Ltd and DataGroup Booksellers Sign Partnership Agreement 2Market Publishers Ltd and DataGroup Booksellers Sign Partnership Agreement 3Immunovaccine Disclaims Hoax Press Release 2Pharmacyclics Provides Clinical Update on BTK Inhibitor for Autoimmune Diseases 2Pharmacyclics Provides Clinical Update on BTK Inhibitor for Autoimmune Diseases 3
... GRAND RAPIDS, Mich., May 20 The West ... it has been selected to review and approve ... the Michigan Pre-Seed Capital Fund. The Michigan ... to support high-tech, high-growth start-up companies in four ...
... May 20 deCODE genetics,(Nasdaq: DCGN ... isolation and,genotyping laboratory, which processes the company,s ... tests for several common,diseases, has been accredited ... a recent inspection. The U.S. Centers for ...
... Launch into High Growth Brazilian Market for Aesthetic ... announced today the receipt of ANVISA clearance to ... in Brazil. ANVISA (Agencia Nacional de Vigilancia ... regulatory agency charged with clearing all applications to ...
Cached Biology Technology:The West Michigan Science & Technology Initiative is Named Statewide Reviewer for Life Science Funding Requests Through New Program 2The West Michigan Science & Technology Initiative is Named Statewide Reviewer for Life Science Funding Requests Through New Program 3deCODE Genotyping Laboratory Receives College of American Pathologists Accreditation 2deCODE Genotyping Laboratory Receives College of American Pathologists Accreditation 3deCODE Genotyping Laboratory Receives College of American Pathologists Accreditation 4Aesthera Announces ANVISA Clearance to Market Photopneumatic Platforms in Brazil 2Aesthera Announces ANVISA Clearance to Market Photopneumatic Platforms in Brazil 3
(Date:1/22/2015)... , Jan. 13, 2015  Today, FreeWavz ( www.FreeWavz.com ... its crowdfunding campaign on Fundable, https://www.fundable.com/freewavz . ... of production capacity to meet customer demand. ... - http://photos.prnewswire.com/prnh/20150113/168790 Invented ...
(Date:1/22/2015)... WINSTON-SALEM, N.C. , Jan. 16, 2015  A man-made ... working memory and other mental capabilities in adults with ... a pilot study led by researchers at Wake Forest ... 60 adults diagnosed with amnesic mild cognitive impairment (MCI) ...
(Date:1/22/2015)... Report Issued by Small Cap IR. In 2011, Nilson Report,s ... at merchants on the leading payment cards rose to $135.3 ... and prepaid cards reached 6.54 billion.  Eight million credit card ... in 2012, and credit and debit card fraud resulted in ...
Breaking Biology News(10 mins):FreeWavz Launches on Fundable to Drive Speed-to-Market in 2015 2Nasal Spray with Insulin Equivalent Shows Promise as Treatment for Adults with Mild Cognitive Impairment, Alzheimer's Dementia 2Nasal Spray with Insulin Equivalent Shows Promise as Treatment for Adults with Mild Cognitive Impairment, Alzheimer's Dementia 3$4.80 Near Term Price Target with "Buy" given by CapRock Research for NXT-ID, Inc. (NASDAQ: NXTD) issued by Small Cap IR 2
... could be used as an early warning system to ... British Ecological Society's Journal of Applied Ecology has found. ... and vocal mimicry, this is the first study to ... on song-matching. , Ecologists recorded and analysed the songs ...
... Sea Grant researchers have isolated a new peptide ... implications for managing many diseases in oysters. , ... may protect against bacteria in Crassostrea virginica, a ... important economically to Atlantic and Gulf Coast fisheries. ...
... Computer scientists and biologists at the Department of ... that can select tens of thousands of high-quality ... and automatically, with accuracy approaching that of experienced ... as "particle picking by segmentation," promises to greatly ...
Cached Biology News:Bird song changes sound alarm over habitat fragmentation 2Picking particles faster than one at a time 2Picking particles faster than one at a time 3Picking particles faster than one at a time 4Picking particles faster than one at a time 5
Request Info...
... [14C] Methylated Protein Molecular Weight Markers, ... proteins enable molecular weight determination of the ... allows visual monitoring of band migration in ... activity of the [14C] version without Rainbow-labeling ...
Request Info...
... Zero Blunt TOPO PCR ... is designed for cloning ... blunt-end PCR products. The ... TOPO Cloning and greater ...
Biology Products: