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.ashx

Contact:
Karen Lim (416) 977-6555 ext 227
clientservices(at)xtalks(dot)com

Read the full story at http://www.prweb.com/releases/2013/4/prweb10594704.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

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:7/18/2017)... DC (PRWEB) , ... July 18, 2017 , ... ... the Allotrope Framework, and has released the first phase of the Allotrope Framework ... World’s Best Practices Awards were created to “not only elevate the critical role ...
(Date:7/17/2017)... ... July 17, 2017 , ... The Academy of Model Aeronautics (AMA) will ... Aviation Day will take place from 9 a.m. to 2 p.m. at the International ... all ages. , Aviation Adventure Day will be packed with entertaining activities for the ...
(Date:7/17/2017)... ... July 17, 2017 , ... ... a wide range of overlapping clinical features. The advancement of targeted next-generation sequencing ... of NDD research and testing. , However, designing a custom panel for ...
(Date:7/17/2017)... ... July 17, 2017 , ... DuPont Pioneer today announced ... website (openinnovation.pioneer.com) dedicated to connecting third-party innovators with DuPont Pioneer scientists is ... enabling technologies, biologicals and digital solutions. , “DuPont Pioneer is building on its ...
Breaking Biology Technology:
(Date:4/5/2017)... LONDON , April 4, 2017 KEY ... is anticipated to expand at a CAGR of 25.76% ... neurodegenerative diseases is the primary factor for the growth ... full report: https://www.reportbuyer.com/product/4807905/ MARKET INSIGHTS The ... of product, technology, application, and geography. The stem cell ...
(Date:4/3/2017)... , April 3, 2017  Data captured ... engineering platform, detected a statistically significant association ... prior to treatment and objective response of ... potential to predict whether cancer patients will ... treatment, as well as to improve both pre-infusion ...
(Date:3/30/2017)... 2017 The research team of The Hong ... fingerprint identification by adopting ground breaking 3D fingerprint minutiae recovery and ... speed and accuracy for use in identification, crime investigation, immigration control, ... ... A research team led ...
Breaking Biology News(10 mins):