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:7/31/2015)... , July 31, 2015 In today,s ... that help them drive positive health outcomes, improve ... source of patient care in their communities. At ... tradeshow and conference, AmerisourceBergen announced a new set ... Services Administration Organization and help independent pharmacies endure ...
(Date:7/31/2015)... ... July 31, 2015 , ... R-Biopharm is proud to ... hydrolyzed gluten in foods, has been accepted by AOAC International as Official First ... in Fermented Cereal-Based Products by R5 Competitive ELISA,” based on a specific monoclonal ...
(Date:7/30/2015)... 2015   GenoSpace , a leading provider ... analysis of genomic and other biomedical data, today ... the company as Vice President of Sales and ... "GenoSpace partners with its customers ... and explore complex sets of genomic, phenotypic and ...
(Date:7/30/2015)... VANCOUVER, Washington , July 30, 2015 ... "Biosimulation Market, by Product (Software, Molecular Modeling, PB/PK, PKPD, ... (Drug Discovery & Development, Preclinical, Clinical Trial), by End ... the Biosimulation Market is expected to reach USD 2,107.99 ... at a CAGR of 15.29%. Browse ...
Breaking Biology Technology:AmerisourceBergen Unveils Suite of Enhanced Capabilities for Independent Pharmacies at ThoughtSpot 2015 2AmerisourceBergen Unveils Suite of Enhanced Capabilities for Independent Pharmacies at ThoughtSpot 2015 3RIDASCREEN® Competitve Gliadin Receives AOAC Official First Action Status 2GenoSpace Introduces Matthew Fischer as Vice President of Sales and Marketing 2Biosimulation Market Worth 2,107.99 Million USD by 2020 2Biosimulation Market Worth 2,107.99 Million USD by 2020 3Biosimulation Market Worth 2,107.99 Million USD by 2020 4
... Inc., a company focused on commercially producing low-carbon biofuels ... produced cellulosic methanol from the initial phase of its ... non-food biomass. The first phase of the ... process, which uses heat, pressure, and steam to convert ...
... IAGX ) announced today results for the three months ... quarter of fiscal year 2011 to $1,085,000 from $1,702,000 for the ... quarter was $604,000 or $.05 per share compared to a loss ... the prior fiscal year.   Commenting on the results ...
... Aug. 17 Today, Pisgah Labs, Inc. ( ... the United States Patent and Trademark office ( ... addressing global stability problems of thyroid hormone drugs. ... hormones effect protein, lipid, and carbohydrate metabolism, growth ...
Cached Biology Technology:Range Fuels Produces Cellulosic Methanol From First Commercial Cellulosic Biofuels Plant 2Imagenetix, Inc. Reports First Quarter 2011 Results 2Imagenetix, Inc. Reports First Quarter 2011 Results 3Pisgah Labs' Invention Improves Safety of Thyroid Hormones 2Pisgah Labs' Invention Improves Safety of Thyroid Hormones 3
(Date:7/31/2015)... , Chine, 31 juillet 2015 ... www.icg-10.org ) sera organisée par le BGI ... Shenzhen en Chine. ... Depuis son inauguration en 2006, l,ICG est devenue ... dans le domaine des « omiques » et c,est aussi ...
(Date:7/31/2015)... , Jul. 31, 2015 NXT-ID, Inc. (NASDAQ: ... authentication company focused on the growing mobile commerce market ... it has filed provisional patent 62/198989 for ... invention highlights a method to advance crypto-currencies such as ... introducing a common, uniform way to manage all payments.  ...
(Date:7/27/2015)... SAN JOSE, Calif. , July 27, 2015 ... leading developer of human interface solutions, today announced ... ClearPad ® touchscreen solution for its stylish ... controller for its proven reliability, low power and ... with a wet finger. Huawei designers also required ...
Breaking Biology News(10 mins):La 10e International Conference on Genomics (ICG-10) doit s'ouvrir en octobre 2La 10e International Conference on Genomics (ICG-10) doit s'ouvrir en octobre 3NXT-ID Patents Electronic Crypto-Currency Management Technology 2NXT-ID Patents Electronic Crypto-Currency Management Technology 3NXT-ID Patents Electronic Crypto-Currency Management Technology 4Synaptics Touchscreen Solution Powers New Huawei Watch 2Synaptics Touchscreen Solution Powers New Huawei Watch 3
... At birth, your body was 100-percent human in terms ... your body will be human and the remaining 90-percent will ... the interactions between your human and microbial cells that go ... especially your resistance to infectious diseases. To learn ...
... An international consortium of researchers from more than 70 ... study of nearly 2,300 people supports the growing consensus that ... copy number variants (CNVs). The study findings, constituting the ... (AGP), were published in Nature on June 9, 2010. The ...
... them to change the acidity of a solution almost ... and Technology (NIST) has demonstrated a simple and effective ... change when the acidity of their environment suddenly changes*. ... of a broader effort at NIST to understand the ...
Cached Biology News:Data acquisition and coordination key to human microbiome project 2Data acquisition and coordination key to human microbiome project 3Data acquisition and coordination key to human microbiome project 4Autism genome project identifies genetic variants that may make people susceptible to disorder 2'Instant acid' method offers new insight into nanoparticle dispersal in the environment and the body 2
BD Falcon 850 cm Smooth-surface TufRol Roller Bottle, tissue-culture treated polystyrene, blow-molded one-piece design, with easy on/off non-vented cap. (2/sp, 20/ca) Packaging: 2 / pack, 20 /...
... This CLS number is ... to easily match Cornings product ... yet, please order under the ... contact customer service for assistance. ...
... a simple and convenient method for the rapid, ... been optimized for use with S. cerevisiae and ... fungus species that is susceptible to yeast lytic ... spheroplasts of yeast cells that are ideal for ...
Four siRNAs targeting your gene of interest, providing gene silencing with 100% satisfaction guaranteed High knockdown potency , High specificity for minimal off-target effects , Flexible siR...
Biology Products: