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:2/28/2017)... ... 2017 , ... Surface Plasmon Resonance (SPR) is a widely-used, label-free technique to ... to changes in the dielectric properties of the medium close to a metal surface. ... up to 300 nm above the metal surface (Au) and thus by the material ...
(Date:2/28/2017)... YORK , Feb. 28, 2017  Phosphorus, ... announced today the formation of the Phosphorus Scientific ... science experts chosen to advise the company on ... large-scale, multi-site research initiatives. Please visit http://phosphorus.com/about-us/ ... and initiatives. "We,ve gathered some of ...
(Date:2/28/2017)...  Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company ... autoimmune diseases, asthma and allergic diseases and cancer, ... and full year ended December 31, 2016 and ... and clinical highlights. "During 2016, we ... by starting five clinical trials across our XmAb ...
(Date:2/28/2017)... MA (PRWEB) , ... February 28, 2017 , ... ... clinical trials, yet requires extensive coordination and expertise. Colpitts Clinical Trial Travel ... celebrating 15 years of meeting this unique need within the biotechnology and pharmaceutical ...
Breaking Biology Technology:
(Date:2/7/2017)... -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), ... the LEERINK Partners 6th Annual Global Healthcare Conference at ... 15, 2017 at 10 a.m. Eastern Time. ... accessed at http://wsw.com/webcast/leerink28/zbh .  The webcast will be ... Investor Relations website at http://investor.zimmerbiomet.com . ...
(Date:2/2/2017)... 2, 2017   TapImmune, Inc. (NASDAQ: ... specializing in the development of innovative peptide and ... cancer and metastatic disease, announced today it has ... of a second clinical lot of TPIV 200, ... alpha. The manufactured vaccine product will be used ...
(Date:1/30/2017)... FRANCISCO , Jan. 30, 2017   Invitae ... the fastest growing genetic information companies, today announced that ... financial results and provide 2017 guidance on Monday, February ... conference call that day at 4:45 p.m. Eastern / ... Invitae,s management team will briefly review financial results, guidance, ...
Breaking Biology News(10 mins):