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:7/31/2014)... famous for a number of breakthroughs, which altered the ... a paper, which laid the foundation of computer science, ... He next played a pivotal role in the Second ... military codes, enabling the Allies to defeat the Nazis ... he turned his attention to artificial intelligence and proposed ...
(Date:7/31/2014)... 2014 According to a new ... Market - Global Industry Analysis, Size, Share, Growth, Trends ... at USD 88.5 million in 2011, which is expected ... a CAGR of 53.8% from 2013 to 2023. ... http://www.transparencymarketresearch.com/quantum-dots.html Increasing demand for energy efficient ...
(Date:7/31/2014)... DUBLIN , July 31, 2014 ... the "Global Genomics Market 2014-2018" report to ... Genomics is the study of the genetic ... to be a strong basis for the discovery and ... of human diseases or health conditions. Genomics is supported ...
(Date:7/31/2014)... San Francisco, Calif. (PRWEB) July 31, 2014 ... provides newly diagnosed patients with an overview of the ... the management of drug side effects, as well as ... , “We’re grateful to Dr. Sandy Srinivas for organizing ... 25-year survivor of kidney cancer. “Sandy and her colleagues ...
Breaking Biology Technology:A mathematical theory proposed by Alan Turing in 1952 can explain the formation of fingers 2A mathematical theory proposed by Alan Turing in 1952 can explain the formation of fingers 3Global Quantum Dots Market is Expected to Reach USD 8,246.8 Million in 2023: Transparency Market Research 2Global Quantum Dots Market is Expected to Reach USD 8,246.8 Million in 2023: Transparency Market Research 3Global Quantum Dots Market is Expected to Reach USD 8,246.8 Million in 2023: Transparency Market Research 4Global Genomics Market 2014-2018: Key Vendors are F. Hoffmann-La Roche, Life Technologies, Qiagen and Illumina 2
... Inc., a privately-,held, specialty pharmaceutical company, announced today ... financing, which included investors Domain Associates,Latterell Venture Partners ... committed to the development of prescription,products based on ... unmet,needs of patients and their caregivers. Meritage Pharma,s ...
... and existing antibiotics to create a broad offering of ... ... LONDON, June 16 Mpex Pharmaceuticals and,GlaxoSmithKline (GSK) today announced ... discovery, development and,commercialization of novel medicines for bacterial diseases. The,collaboration ...
... Medullary Thyroid Cancer Planned to Initiate This Summer, ... Inc. (Nasdaq: EXEL ) announced today that ... (FDA) have reached agreement on the phase 3,registration ... targeting,MET, RET, and VEGFR2, via the Special Protocol ...
Cached Biology Technology:Meritage Pharma, Inc. Announces Company Formation and $22.5M Series A Financing 2GlaxoSmithKline and Mpex Pharmaceuticals Form Alliance to Develop Novel Efflux Pump Inhibitors for Use Against Serious Gram-Negative Infections 2GlaxoSmithKline and Mpex Pharmaceuticals Form Alliance to Develop Novel Efflux Pump Inhibitors for Use Against Serious Gram-Negative Infections 3GlaxoSmithKline and Mpex Pharmaceuticals Form Alliance to Develop Novel Efflux Pump Inhibitors for Use Against Serious Gram-Negative Infections 4GlaxoSmithKline and Mpex Pharmaceuticals Form Alliance to Develop Novel Efflux Pump Inhibitors for Use Against Serious Gram-Negative Infections 5Exelixis Reaches Agreement with FDA on Special Protocol Assessment for XL184 Phase 3 Trial 2Exelixis Reaches Agreement with FDA on Special Protocol Assessment for XL184 Phase 3 Trial 3Exelixis Reaches Agreement with FDA on Special Protocol Assessment for XL184 Phase 3 Trial 4Exelixis Reaches Agreement with FDA on Special Protocol Assessment for XL184 Phase 3 Trial 5
(Date:7/31/2014)... Oren Tessler, Assistant Professor of Clinical Surgery at LSU ... part of a team of plastic and reconstructive surgeons ... to screen and select patients for a specific surgical ... who underwent this surgery to decompress the nerves that ... cosmetic eyelid surgery. The study, which confirms the benefit ...
(Date:7/31/2014)... Biometrics industry sees growth as ... companies turn towards digital currency: NXT-ID, Inc. (OTCBB: NXTD), ... (NASDAQ: AMZN ), Facebook Inc. (NASDAQ: ... ) and Microsoft Corporation (NASDAQ: MSFT) NXT-ID, Inc., ... m-commerce market, announces a video featuring its next generation ...
(Date:7/30/2014)... paving the way for a breakthrough that may ... exposed to poisonous chemicalsparticularly those in pesticides and ... current issue of the journal ChemBioChem ... compounds commonly used in pesticides and warfare agents. ... of Engineering Associate Professor of Chemical and Biological ...
Breaking Biology News(10 mins):Surgeons report significant migraine relief from cosmetic eyelid surgery technique 2Smart Technology Consumer's Interest in Mobile Payment Products Grows - Company Secures Deal with Major Airline to Display Advertisements in Flight for its Next Generation Smart Wallet 2Smart Technology Consumer's Interest in Mobile Payment Products Grows - Company Secures Deal with Major Airline to Display Advertisements in Flight for its Next Generation Smart Wallet 3Smart Technology Consumer's Interest in Mobile Payment Products Grows - Company Secures Deal with Major Airline to Display Advertisements in Flight for its Next Generation Smart Wallet 4Smart Technology Consumer's Interest in Mobile Payment Products Grows - Company Secures Deal with Major Airline to Display Advertisements in Flight for its Next Generation Smart Wallet 5Smart Technology Consumer's Interest in Mobile Payment Products Grows - Company Secures Deal with Major Airline to Display Advertisements in Flight for its Next Generation Smart Wallet 6Engineering a protein to prevent brain damage from toxic agents 2
... 6, 2013  Daniel P. Linskey, superintendent-in-chief of the Boston ... Marathon Bombings" at the 2013 IEEE International Conference on Technologies ... Linskey,s talk will focus on the aftermath of the tragic ... department and federal enforcement agencies that ultimately led to the ...
... in the early 1990s, the protein STAT1 (Signal Transducer ... be central in passing signals across immune cells, ensuring ... from viruses or other pathogens. Animals without STAT1 are ... somehow involved in protection against malignant cells. The STAT1 ...
... To protect consumers, screening shellfish for fungal toxins is ... September) in the Society for Applied Microbiology (SfAM) journal, ... an area with contamination by strains of Penicillium ... will contain toxins at much higher levels that are ...
Cached Biology News:Boston Police Chief to Address Boston Marathon Bombings at IEEE Homeland Security Conference in Waltham, Mass., on 12 November 2Static killers? 2
Request Info...
supplied with 10x reaction buffer...
... ATP: D-hexose 6- phosphotransferase/D-glucose-6-phosphate: NADP ... of HK will phosphorylate 1 ... min at 25C at pH ... will oxidize 1 mol of ...
Request Info...
Biology Products: