Comments
yourfanat wrote: I am using another tool for Oracle developers - dbForge Studio for Oracle. This IDE has lots of usefull features, among them: oracle designer, code competion and formatter, query builder, debugger, profiler, erxport/import, reports and many others. The latest version supports Oracle 12C. More information here.
Cloud Expo on Google News
SYS-CON.TV
Cloud Expo & Virtualization 2009 East
PLATINUM SPONSORS:
IBM
Smarter Business Solutions Through Dynamic Infrastructure
IBM
Smarter Insights: How the CIO Becomes a Hero Again
Microsoft
Windows Azure
GOLD SPONSORS:
Appsense
Why VDI?
CA
Maximizing the Business Value of Virtualization in Enterprise and Cloud Computing Environments
ExactTarget
Messaging in the Cloud - Email, SMS and Voice
Freedom OSS
Stairway to the Cloud
Sun
Sun's Incubation Platform: Helping Startups Serve the Enterprise
POWER PANELS:
Cloud Computing & Enterprise IT: Cost & Operational Benefits
How and Why is a Flexible IT Infrastructure the Key To the Future?
Click For 2008 West
Event Webcasts
FDAnews announces Fifth Annual Risk Management & Drug Safety Summit

FALLS CHURCH, Va., Nov. 9, 2012 /PRNewswire-iReach/ --
Fifth Annual Risk Management & Drug Safety Summit:
Building an Effective Global Risk Management and Drug Safety Program
**Presented by FDAnews**
Dec. 3-4, 2012Washington, DC

(Photo: http://photos.prnewswire.com/prnh/20121109/CG10179)

www.fdanews.com/REMS

There are now about 200 unique REMS and four classwide REMS.  And big changes are coming.

PDUFA V moves REMS discussions earlier in the review process for sponsors of new molecular entity NDAs and original BLAs. With REMS discussions commencing as early as pre-NDA meetings, the agency is determining how to create a more predictable system for requiring REMS and deciding what tools a REMS should involve.

CDER (in conjunction with CBER) plans to issue new guidance to determine when a REMS is required, both preapproval and postapproval. The guidance must be released in September 2013.

Plus, the FDA is planning to hold a series of public meetings to determine the best methods for assessing the effectiveness of REMS.

Are you in the know on these changes?  Will you be ready when they hit your product?

Register today to join a select group of drug industry executives who have, over the past four years, sought to shape the future of REMS and global drug safety.

This is your year to be among them.  Register now to join with colleagues for the Fifth Annual Risk Management and Drug Safety Summit.

Invest two days. Meet new colleagues and make new contacts. Ask questions directly of industry thoughts leaders, such as Douglas Throckmorton, M.D., Deputy Director Regulatory Programs, CDER, FDA (invited), Greg Fiore, M.D., Chief Medical Officer and Acting Head of Global Pharmacovigilance, The Medicines Company and Richard Hermann, M.D., M.P.H., Safety Science Physician, AstraZeneca.

Click here to see the agenda                                                                 

You'll also be brought up to speed on these critical topics:

  • CDER's Efforts to Improve Risk Management and Drug Safety
  • Problems Encountered When Innovator and Generic Firms Have to Share a REMS
  • How to Design an Effective ETASU with Integrated Digital Elements
  • Suspicious Order Monitoring (SOM) Regulatory and Policy Requirement — An Effective Investigative Program
  • Application of the Benefit-Risk Action Team (BRAT) Framework in Pharmaceutical R&D
  • Panel Discussion: Opioid REMS and What It Signals for the Future of REMS
  • The Powerful New Platform for Risk Management and Safety Communications: Electronic Health Records
  • Pharmacoepidemiology in Safety Signal Assessment

How will the Fifth Annual Risk Management and Drug Safety Summit make a bottom-line difference to you?  Here's what previous attendee Parul Vold, Medical Director, Global Pharmacovigilance, Lundbeck, Inc., said:

"This is the best conference on risk management that I have ever attended. It is money well spent. Even seasoned pharmacovigilance persons will learn something new and/or gain a valuable new perspective."

Meet Your Chair:

Peter Pitts is co-founder and president of Center for Medicine in the Public Interest.  Prior to founding CMPI, Mr. Pitts was a senior fellow for healthcare studies at the Pacific Research Institute, a San Francisco-based think tank.  From 2002-2004, he was the FDA's associate commissioner for external relations, serving as the agency's "chief messaging officer," where his challenge was to clearly define the FDA's brand image and to communicate the agency's main themes to its many constituencies.

Host Sponsor:
Center for Medicine in the Public Interest is a nonprofit, nonpartisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, healthcare reform and comparative effectiveness.

Register Today

Who Should Attend

  • Executive Management
  • Regulatory Affairs
  • Risk Management Professionals
  • Clinical Safety/Pharmcovigilance
  • Medical Affairs/Medical Safety
  • Research and Development
  • Commercial Affairs/Business Development
  • Clinical Trial Directors   

CONFERENCE DETAILS

Fifth Annual Risk Management & Drug Safety Summit:
Building an Effective Global Risk Management and Drug Safety Program
**Presented by FDAnews**
Dec. 3-4, 2012Washington, DC

TUITION: $1,967 per attendee

4 Easy Ways to Register
Online:         http://www.fdanews.com/REMS
By phone: 888-838-5578 or 703-538-7600
Fax:         703-538-7676
Mail to:     FDAnews
                         300 N Washington St
                         Ste 200
                         Falls Church VA USA 22046-3431

Media Contact:
Jeff Grizzel FDAnews, 703-538-7668, jgrizzel@fdanews.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE FDAnews

About PR Newswire
Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Cloud Developer Stories
The Internet of Things is not new. Historically, smart businesses have used its basic concept of leveraging data to drive better decision making and have capitalized on those insights to realize additional revenue opportunities. So, what has changed to make the Internet of Things...
up.time, from uptime software, monitors performance, availability and capacity across all servers, virtual machines, applications, IT services, and the network. Proactively find IT system performance issues before they happen, report on total capacity, easily identify troublemake...
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation o...
Cloud services provider SherWeb on Tuesday announced that it has acquired ORCS Web Inc., a Windows-based managed hosting provider headquartered in Charlotte, North Carolina. OrcsWeb will continue to operate as a wholly owned SherWeb subsidiary. Other terms of the agreement have n...
Ericsson on Tuesday announced it has entered into an agreement to acquire US-based MetraTech Corp., a provider of metadata-based billing, commerce and settlement solutions uniquely adaptable to multiple business models and industries. The acquisition includes all 140 employees a...
Subscribe to the World's Most Powerful Newsletters
Subscribe to Our Rss Feeds & Get Your SYS-CON News Live!
Click to Add our RSS Feeds to the Service of Your Choice:
Google Reader or Homepage Add to My Yahoo! Subscribe with Bloglines Subscribe in NewsGator Online
myFeedster Add to My AOL Subscribe in Rojo Add 'Hugg' to Newsburst from CNET News.com Kinja Digest View Additional SYS-CON Feeds
Publish Your Article! Please send it to editorial(at)sys-con.com!

Advertise on this site! Contact advertising(at)sys-con.com! 201 802-3021



SYS-CON Featured Whitepapers
ADS BY GOOGLE

Breaking Cloud Computing News
Inphi Corporation (NYSE: IPHI), a leading provider of high-speed mixed signal semiconductor solution...