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:8/31/2014)... Texas (PRWEB) August 31, 2014 ... the current state of the Epoxy Hardener ... a basic overview of the industry, including definitions, ... and Chinese domestic market analysis are provided with ... landscape of the market. A comparison between the ...
(Date:8/29/2014)... August 29, 2014 The global ... billion in 2019. It is expected to grow ... 2019, and was valued at $1.8 billion in ... Transparency Market Research. , For more information regarding ... . , The research report, titled “Companion Diagnostics ...
(Date:8/29/2014)... Hills, NY (PRWEB) August 29, 2014 ... Burnt Hills Veterinary Hospital are seeking candidates to participate ... dogs with osteoarthritis. The ultimate goal of this ... donor stem cells into one or two arthritically affected ... treated joints. , Candidates for the current investigational ...
(Date:8/29/2014)... San Antonio, TX (PRWEB) August 29, 2014 ... 9001:2008 and ISO 13485:2003 certified, GAMP® 5 compliant ... been awarded an international Phase II clinical trial ... non-Hodgkin’s lymphoma. , Throughout this trial, Intrinsic Imaging ... but not limited to, protocol and charter development, ...
Breaking Biology Technology:Epoxy Hardener Industry Development Trends in Global & China Regions Now Available at ReportsnReports.com 2Epoxy Hardener Industry Development Trends in Global & China Regions Now Available at ReportsnReports.com 3Companion Diagnostics Market to Hit $5.6 Billion in 2019: Transparency Market Research 2Companion Diagnostics Market to Hit $5.6 Billion in 2019: Transparency Market Research 3Burnt Hills Veterinary Hospital Seeks Candidates for an Investigational Study of Stem Cells for Dogs with Arthritis 2Intrinsic Imaging Awarded Phase II Clinical Trial to Assess New Treatment for Non-Hodgkin’s Lymphoma 2
... HALIFAX, May 23 /PRNewswire/ - ImmunoVaccine Technologies Inc. ... for being,recognized as one of Pennsylvania,s Best 50 ... of Immunotope Inc., received the honors,from Pennsylvania Governor ... in the biotech industry. Her clinical work in,antigen ...
... EXTON, Pa., May 23 BioTrends Research ... Nephrology," providing insight,into the referral patterns and ... from the perspective of Nephrologists,Cardiologists, Endocrinologists, and ... offers a comprehensive view, based on,qualitative interviews ...
... and PHILADELPHIA, Pennsylvania, May 23, Shire Limited ("Shire") (LSE: ... an,application has been made to the UK Listing Authority ... of 5 pence each in the,capital of Shire to ... on the,London Stock Exchange. Dealings will commence today at ...
Cached Biology Technology:ImmunoVaccine Technologies Congratulates Dr. Ramila Philip as One of PA's Best 50 Women in Business 2Nephrologists and Non-Nephrologists Alike Report Increased Attention on Chronic Kidney Disease 2Application for Listing of Shire Limited Ordinary Shares 2Application for Listing of Shire Limited Ordinary Shares 3
(Date:9/2/2014)... researchers at the University of Warwick in the UK ... in the Journal Early Human Development , has ... hospital after birth and the use of mechanical ventilation ... children. , Mathematic abilities are crucial for lifelong academic ... preterm children. Earlier studies of children who are born ...
(Date:9/2/2014)... is considered the most ideal source of nutrition ... critical role in the evolution and civilizations of ... contains a large number of bacterial species, including ... as no surprise to scientists and physicians. , ... to be the result of co-evolutionary and co-adaptive ...
(Date:9/2/2014)... 2, 2014) In the battle between our immune ... ally in bacteria-killing viruses known as phages. In a ... Partners In Health, Haiti,s National Public Health Laboratory, and ... give up their virulence in order to survive. Importantly, ... found that cholera,s mutational escape from phage predation occurs ...
Breaking Biology News(10 mins):Mechanical ventilation a key indicator for pre-term children's math problems 2Are human breast milk microbiome 'neutral'? 2Are human breast milk microbiome 'neutral'? 3War between bacteria and phages benefits humans 2War between bacteria and phages benefits humans 3
... Society has announced the winners of its second ... Society,s 57th Annual Meeting at the Pennsylvania Convention ... Society,s Committee for Professional Opportunities for Women (CPOW), ... number of women biophysicists and encourage their participation ...
... male jaguar and an adult male ocelot have been photographed ... monitoring cameras. The images were collected as part of the ... Arizona. Both animals appear to be in good health. ... from wildlife cameras set up as part of the research ...
... LA JOLLA, CA January 8, 2013 - Chemists at The ... one of the most fundamental tasks in molecular biology. Their new ... that these cells may be easily located and/or selected out from ... in a recent issue of the chemistry journal Angewandte Chemie ...
Cached Biology News:Biophysical Society announces winners of 2013 CPOW travel awards 2Wildlife monitoring cameras click jaguar and ocelot photos 2Wildlife monitoring cameras click jaguar and ocelot photos 3Chemists devise inexpensive, benchtop method for marking and selecting cells 2Chemists devise inexpensive, benchtop method for marking and selecting cells 3