Navigation Links
Risk Assessment and Mitigation in Phase I Trials in High Risk Compounds: A Continuously Developing Process, new life science webinar hosted by Xtalks
Date:4/4/2013

Toronto, Canada (PRWEB) April 04, 2013

Phase 1 studies are typically aimed at optimizing dosage and furthering pharmacokinetic studies — in these cases, the risk is not balanced by a potential benefit for the participating healthy volunteers or patients. For this reason, it is essential that the risk is minimized and that any unanticipated harm be rapidly detected and contained.

Valuable directions to ensure subject safety are given by, for instance, the 2007 EMEA guideline on identification and mitigation of Risks in First-In-Human Trials and the MHRA Phase 1 Accreditation Scheme.

The challenge remains in translating the guidelines into daily practice in a Phase I setting. New compound classes and design elements pose unique challenges to the risk mitigation process. Therefore the risk mitigation process is not only evolving within a single study but has to continue evolving as a whole.

Join our speaker, Dr. Thijs van Iersel, Senior Director of Scientific Affairs at PRA for an in-depth look at strategies to implement risk minimization procedures in Clinical Pharmacology Units at PRA.

A Q&A with the audience will follow the main presentation.

For more information about this event or to register, visit: http://xtks.in/xto584-event

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.a
'/>"/>

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

Page: 1 2

Related biology technology :

1. ICD-10 Coding Knowledge Assessment Tool Released
2. Riordan Clinic Research Institute Has Developed and Patented a Process for the Assessment of the Energy Metabolism in Patients with Chronic Fatigue Syndrome
3. Neuroendocrine Carcinoma Therapeutics - Pipeline Assessment and Market Forecast to 2019
4. In Vitro Diagnostics (IVD) - Emerging Countries (Brazil, Russia, India, China) Opportunity Assessment, Competitive Landscape and Market Forecasts to 2018
5. Hepatitis B Therapeutics - Pipeline Assessment and Market Forecasts to 2019
6. Addisons Disease (Primary or Chronic Adrenal Insufficiency) Therapeutics - Pipeline Assessment and Market Forecasts to 2019
7. CoreLab Partners, Medical Image Assessment Experts, Announces Its Entry Into the Early Alzheimers Imaging Market Space
8. BioInformatics LLC New Product Launch – RateMyProduct, a Quick Turnaround Product Assessment Tool for Life Science Suppliers
9. Research and Markets Announces Addition of the "Risk - Reward of Developing a Herceptin Biosimilar - A Thorough Assessment" Report to its Offering
10. Douglas Harrington, MD Addresses Select Group Of Physicians Regarding Latest Advances In Cardiovascular Risk Assessment
11. Amgen and FDA Agree to Modify Nplate® (Romiplostim) Risk Evaluation and Mitigation Strategy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... , Oct. 22, 2014 /PRNewswire/ - iCo Therapeutics ("iCo" ... announced next steps for its Oral Amphotericin B ... its in vitro work involving samples ... now plans to complete pre clinical studies and ... Phase 1A clinical trial, utilizing approximately $700,000 of ...
(Date:10/22/2014)... DUBLIN , Oct. 22, 2014 ... "Organic Electronics Market by Material, by Application, Geography ... report to their offering. Organic electronics, ... a branch of material science which deals with small ... as organic because small molecules and polymers are carbon ...
(Date:10/20/2014)... The report “Pharmacy Automation Systems Market by product ... Table-top Counters) by End-user (Inpatient Pharmacy Automation, Outpatient ... 2019” analyzes and studies the major market drivers, ... and the Rest of the World (RoW). , ... through 300 pages and in-depth TOC on "Pharmacy ...
(Date:10/20/2014)... 2014 Convey Computer , the ... from Iowa State University won first place in the ... Convey HC-2ex, the team’s solution achieved the highest overall ... the second place finisher. , Experts from all segments ... month long challenge, using a variety of design tools, ...
Breaking Biology Technology:iCo Therapeutics Announces Advancement of Oral Amphotericin B Program 2iCo Therapeutics Announces Advancement of Oral Amphotericin B Program 3Global Organic Electronics (Semiconductor, Conductive, Dielectric and Substrate) Market - Analysis and Forecast (2014 - 2020) 2Global Organic Electronics (Semiconductor, Conductive, Dielectric and Substrate) Market - Analysis and Forecast (2014 - 2020) 3Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 2Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 3Pharmacy Automation Systems Market worth $4,566.2 Million by 2019 - New Research Report by MarketsandMarkets 4Team from Iowa State Wins 2014 MemoCODE Design Contest Using Convey HC-2ex 2Team from Iowa State Wins 2014 MemoCODE Design Contest Using Convey HC-2ex 3
... on powerful computational tools and a state-of-the-art scanning ... Wisconsin-Madison and Iowa State University materials science and ... structure in solid metallic materials known as metallic ... Physical Review Letters , the findings fill ...
... May 11, 2012   Synthetic Biologics, Inc. (NYSE Amex: ... and innovative disease-modifying medicines for serious illnesses, announced today ... Board, it has split the roles of Chairman and ... serve as its independent, non-executive Chairman of the Board. ...
... ORLANDO, Fla., May 10, 2012   GeneLink, Inc. ... leading consumer genomics biotech company, reports financial results for the ... Results: , The Company reached an agreement ... Life Sciences, Inc. to Capsalus Corp (OTCBB:WELL.OB, or "Capsalus"). Capsalus ...
Cached Biology Technology:In metallic glasses, researchers find a few new atomic structures 2In metallic glasses, researchers find a few new atomic structures 3Synthetic Biologics Appoints Jeffrey J. Kraws as Independent Chairman 2Synthetic Biologics Appoints Jeffrey J. Kraws as Independent Chairman 3GeneLink Reports 2011 Financial Results 2GeneLink Reports 2011 Financial Results 3
(Date:10/17/2014)... German . Why ... order to reproduce? And why are there two sexes anyway? ... issue of the research journal Molecular Human Reproduction ... from Bielefeld University Bielefeld has compiled this special issue on ... female to copulate with several males in quick succession – ...
(Date:10/16/2014)... have a new synthesis of recent research findings to ... in the two states. , The Ecology and ... Washington: A Synthesis of the Relevant Biophysical Science and ... published by the U.S. Forest Service,s Pacific Northwest Research ... managers for a synthesis of the large body of ...
(Date:10/16/2014)... 2014 NXT-ID, Inc. (NASDAQ: NXTD ... authentication company focused on the growing mobile commerce market ... Wocket™, the Smart Wallet, at the 13 th ... leading global conference on the intersection of technology and ... Anderson , founder and publisher of the Strategic News ...
Breaking Biology News(10 mins):Sperm wars 2New report synthesizes best available science on management of moist mixed-conifer forests 2NXT-ID Inc. to Present at 13th Annual FiRe Conference 2NXT-ID Inc. to Present at 13th Annual FiRe Conference 3
... racking your brain on a Monday morning to remember where ... those keys, you can thank the hippocampus, a brain region ... that room where your keys were hiding in an unusual ... Biological Studies have helped explain how the brain keeps track ...
... A dysfunction of a certain Calcium channel, the so called ... cause different motor diseases as well as a special type ... Dr. Melanie Mark and Prof. Dr. Stefan Herlitze from the ... of the P/Q-type in the modulatory input neurons of the ...
... compared water quality trends in forested streams across the country ... changes. The study, which draws on decades, worth of ... Rico, underscores the value of long-term data in understanding the ... rivers. It is published in the current issue of the ...
Cached Biology News:The neuroscience of finding your lost keys 2The neuroscience of finding your lost keys 3Dysfunction in cerebellar Calcium channel causes motor disorders and epilepsy 2Study explores long-term water quality trends in near-pristine streams 2
... CultureWell cell culture systems provide an ... for staining and imaging. Each system ... standard optical-quality coverslips in cell culture ... sterile and ready to use. Individual ...
RECOMBINANT EQUINE IL-4 Product Type: Recombinant Protein...
RECOMBINANT EQUINE TNF ALPHA Product Type: Recombinant Protein...
Request Info...
Biology Products: