Navigation Links
Webinar to Explore FDA Draft REMS Guidance and Its Implications for Lifecycle Management
Date:12/3/2009

WILMINGTON, Del., Dec. 3 /PRNewswire/ -- ParagonRx, a Delaware-based company specializing in pharmaceutical risk management and optimal medication use, will host a free webinar on Wednesday, Dec. 9, on the FDA's draft guidance on REMS - Risk Evaluation Mitigation Strategy - programs and its implications for REMS lifecycle management. Dr. Gary Slatko, chief medical officer of ParagonRx and an expert on REMS and risk management programs, will lead the one-hour program beginning at 11 a.m. EST.

"While much within the guidance was anticipated, there were some aspects that were both unexpected and represent exciting opportunities for our industry," Dr. Slatko said. "These include new options, such as implementing voluntary risk mitigation measures beyond a REMS, modifying the assessment timetable and modifying the REMS program and/or its goals. Other aspects were incompletely addressed, such as evidence-based risk assessment and patient tools beyond Medication Guides."

Anyone interested in the topic may participate by registering at http://www.paragonrx.com/calendar/78/42-FDA-Draft-REMS-Guidance-Implications-and-Opportunities-for-REMS-Lifecycle-Management. ParagonRx has also published a series of articles summarizing the guidance (http://blog.paragonrx.com).

SOURCE ParagonRx


'/>"/>
SOURCE ParagonRx
Copyright©2009 PR Newswire.
All rights reserved

Page: 1

Related medicine technology :

1. With Flu Season Underway, International SOS to Host H1N1 Update Webinar
2. TorreyPines Therapeutics to Host Webinar at 11 a.m. EDT Today on the Opportunity for Treating Chronic Pain, Migraine and Muscle Spasticity Through Inhibition of Neurotransmitter Glutamate
3. Urologist and Allergist Explore Link Between Allergies and Interstitial Cystitis
4. Research Explores the Effects of Stem Cell Source and Patient Age on Stem Cell Transplantation Outcomes
5. 42 Top U.S. Scientists and Specialists Explore Cutting-Edge Innovations to Defend America From Dangerous Zoonotic Diseases
6. New Survey Explores the Impact of Insulin Injections and Communications Between Patients and Healthcare Providers
7. SPIRIT II Explores Long-Term Performance of XIENCE V Stent
8. A Worldwide Phase III Clinical Trial Seeks U.S. Patients to Explore Investigational Drug Phenoxodiol
9. ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
10. CryoLife Provides Initial 2010 Financial Guidance
11. NxStage(R) Reports Third Quarter 2009 Financial Results and Raises Revenue Guidance for Fiscal 2009
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... , Dec. 2, 2016 Lianluo Smart ... or "the Company") which develops, markets and sells ... China and international markets, ... Diagnosis and Treatment New Progress Forum, co-hosted by ... Guangdong Province , Guangdong Provincial People,s Hospital ...
(Date:12/2/2016)... -- On Thursday, the NASDAQ Composite ended the ... Average edged 0.36% higher, to finish at 19,191.93; and the ... based as six out of nine sectors ended the day ... following Services equities: Myriad Genetics Inc. (NASDAQ: MYGN ... Holdings Inc. (NASDAQ: INCR ), and La Quinta ...
(Date:12/2/2016)... , Dec. 1, 2016  Today, Simpson Healthcare ... the honor of being selected as winners of multiple ... Healthcare Executives Website at the PLATINUM level, Blue Zones ... Module at the GOLD Level, and our proprietary 3ConneX ... At Simpson Healthcare Executives, we are excited to showcase ...
Breaking Medicine Technology:
(Date:12/2/2016)... ... December 02, 2016 , ... Sourced from the Isbre ... unique properties including its unmatched natural purity of just 6 ppm TDS (Total Dissolved ... , Nothing Water has been available in several ShopRite and FoodTown stores in NJ ...
(Date:12/2/2016)... ... December 02, 2016 , ... Clarify ... it has raised $6.0 million in an initial round of funding. The round ... patients and their caregivers can receive far better care through the application of ...
(Date:12/2/2016)... , ... December 02, 2016 , ... ‘Tis the season ... of $1,000 each from the National Family Partnership and the Drug Enforcement Administration as ... decorated their homes and the 10 winning schools who decorated their campuses with this ...
(Date:11/30/2016)... ... November 30, 2016 , ... Standard Process, Inc. is proud ... and recognition of the largest closely held companies headquartered in Wisconsin. This marks ... addition, Standard Process was awarded the Talent Award for providing outstanding employee benefits. ...
(Date:11/30/2016)... ... November 30, 2016 , ... ... and stylish design wanted by today’s consumers at an affordable price, is now ... says the new watch is “a game changer” when it comes to the ...
Breaking Medicine News(10 mins):