Navigation Links
Challenges With Planning and Generation of Development Safety Update Reports (DSURs) and How to Overcome Them, New Life Science Webinar Hosted by Xtalks
Date:10/25/2013

Toronto, Canada (PRWEB) October 25, 2013

The Development Safety Update Report (DSUR) is an aggregate safety report covering drugs, biologics, vaccines or combo products, whose format is harmonized by ICH E2F guideline The DSUR is accepted in most countries worldwide. It replaces the EU Annual Safety Report and the IND Annual Report. These former reports were not as complex as the DSUR. Because of that complexity an intensive training of staff responsible for generation of DSURs is highly recommended. In the training special attention is to be paid to the definition of the Development International Birthdate (DIBD) and the reporting period, the programming of line listings and summary tabulations, correct categorization of ongoing and completed clinical trials as well as on risk analysis and risk-benefit considerations.

In this webinar attendees will learn about the importance of early and careful planning of all activities related to the generation and submission of DSURs, which includes resource planning. The DSUR contains some unblinded data, which is an additional challenge for smaller companies as personnel involved in the conduct of ongoing studies may not be involved in the DSUR preparation or review. Finally the speaker will share guidance for the review of the draft report ensuring that the final DSUR not only meets regulatory requirements, but is also a useful tool to understand the benefit-risk profile of your compound and a valuable data source for its further development.

For more information about this event or to register, visit: http://xtalks.com/Challenges-with-Development-Safety-Update-Reports.ashx

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry
'/>"/>

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

Page: 1 2

Related biology technology :

1. Day Two of AdvaMed 2013 to Feature Government and Industry Leaders on MedTech Challenges and Opportunities
2. Top 3 Business Development Challenges in Chemicals Addressed in SpecialChem White Paper
3. Women in Science Grant Challenges Status Quo Animal Research
4. 6th BSMA Annual Executive Summit to Address the Supply Chain Challenges and Solutions of Biopharma
5. Addressing Scientific and Regulatory Challenges for Abuse Liability Studies, New Life Science Webinar Hosted by Xtalks
6. Universal Stem Cell Product Could Overcome Key Challenges in Donor Organ Transplants
7. Clinverse, Inc. Introduces ClinSpend to Meet Challenges of Sunshine Act Reporting Requirements
8. New York Blood Centers Research Institute Receives Grand Challenges Explorations Grant For Groundbreaking Research in Global Health and Development
9. Challenges and Solutions in Conducting Biosimilar Trials, New Life Science Webinar Hosted by Xtalks
10. MBC Helps Internal Medicine Specialists in Florida Tackle Medicare & Medicaid Fee Parity Initiative Challenges
11. Slone Partners CEO & President Speak about Hiring Challenges in Molecular Diagnostics at Executive War College 2013
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... 2013 was a banner year of continued innovation ... continued independent research led by the team at Wake ... million grant from the Susanne Marcus Collins Foundation, had ... reviewed journal, Amy Grant highlighted Brainwave Optimization® in First ...
(Date:1/14/2014)... Washington, DC (PRWEB) January 14, 2014 ... session for Thursday, January 23, 2014 at 2pm EST ... Actionable Knowledge.” The topic focuses on how technology can ... mission critical decisions for government agencies. The online webinar ...
(Date:1/14/2014)... The largest international professional organization of scientists ... derivatives thereof has endorsed an educational program that ... challenges of adulterated herb and botanical products. ... The Society for Medicinal Plant and Natural Product ...
(Date:1/14/2014)... Global Record Systems, LLC, (GRS), ... solutions for patients, physicians, the biopharmaceutical industry, regulators, ... the signing of a three-year Research Collaboration Agreement ... (FDA). This initiative is designed to generate ...
Breaking Biology Technology:Dynamic Innovative Technology Showcased at Scottsdale Company’s Open House 2Dynamic Innovative Technology Showcased at Scottsdale Company’s Open House 3Webcast - Natural Language Processing: Converting Raw Data into Actionable Knowledge – Hosted by Carahsoft and CDS Federal Services 2World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 2World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 3World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 4World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 5World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 6World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 7World's Largest Group of Medicinal Plant Researchers Endorses ABC-AHP-NCNPR Botanical Adulterants Program 8Global Record Systems Announces Research Collaboration Agreement with FDA to Create a Novel “Big Data” Paradigm for Collection of Patient Safety and Outcomes Information 2
... North ... America, DEERFIELD, Ill., ... Cartago, Costa Rica has been,recognized with the 2008 Shingo Prize for Operational ... North America,-- is being honored for its achievements in driving higher quality ...
... announced today it,submitted to the U.S. Food & ... Application (BLA) for motavizumab, an investigational,monoclonal antibody (MAb) ... supported by clinical trial data from more than ... of serious disease,caused by respiratory syncytial virus (RSV) ...
... Unique and Innovative Formulation Available Without a ... Prescription ... today announced the,launch of PSORENT, a clinically proven, steroid-free, ... which has,proven efficacy against psoriasis symptoms, in a novel, ...
Cached Biology Technology:Baxter's Costa Rica Facility Recognized With Shingo Prize for Excellence in Manufacturing 2MedImmune Submits Biologics License Application to FDA for Motavizumab 2MedImmune Submits Biologics License Application to FDA for Motavizumab 3NeoStrata(R) Announces the Launch of PSORENT(TM) Psoriasis Topical Treatment 2
(Date:4/22/2014)... Winsor Lowe, interim director of the University of Montana,s ... in the Proceedings of the National Academy of Sciences ... network. , ... the U.S. Geological Survey, the University of Washington, the Cary ... U.S. Forest Service Northern Research Station examined 664 water samples ...
(Date:4/22/2014)... Scientists at the University of Massachusetts Amherst and the ... week report that they have discovered a new genus ... the Negro River in the Amazonia State of Brazil. ... Adlia Nogueira and Jos Antnio Alves-Gomes of INPA, describe ... the journal Proceedings of the Natural Sciences of ...
(Date:4/22/2014)... Mass. Analyzing thousands of breeding bird surveys sent ... and Canada over 35 years, wildlife researchers report that ... either northward or toward higher elevation in response to ... This means that most previous studies of potential climate ... factor or the other have likely underestimated the effects ...
Breaking Biology News(10 mins):New research focuses on streamwater chemistry, landscape variation 2New electric fish genus and species discovered in Brazil's Rio Negro 2Wildlife response to climate change is likely underestimated, experts warn 2
... 2011 Reportlinker.com announces that a new ... catalogue: Global Biometrics Industry ... This report analyzes the worldwide markets ... the following Technologies: AFIS (Automated Fingerprint Identification ...
... CA ---- Researchers at the Salk Institute for Biological Studies ... potentially cure sickle cell disease and many other disorders caused ... The technique uses cells from a patient,s skin to ... developing into various types of mature tissues -- including blood. ...
... the endowments of genes in other animals and plants are like ... a genetic sense introduces an element of variety and surprise that ... in a review of more than 100 studies on the topic ... and colleagues focus on cytosine, one of the four chemical "bases" ...
Cached Biology News:Global Biometrics Industry 2Global Biometrics Industry 3Global Biometrics Industry 4Global Biometrics Industry 5Global Biometrics Industry 6Global Biometrics Industry 7Global Biometrics Industry 8Global Biometrics Industry 9Global Biometrics Industry 10Global Biometrics Industry 11Global Biometrics Industry 12Global Biometrics Industry 13Global Biometrics Industry 14Global Biometrics Industry 15Global Biometrics Industry 16Global Biometrics Industry 17Global Biometrics Industry 18Global Biometrics Industry 19Global Biometrics Industry 20Global Biometrics Industry 21Global Biometrics Industry 22Global Biometrics Industry 23Global Biometrics Industry 24Salk researchers develop safe way to repair sickle cell disease genes 2Salk researchers develop safe way to repair sickle cell disease genes 3Salk researchers develop safe way to repair sickle cell disease genes 4
Rabbit Anti-melatonin (different linkage) Polyclonal Antibody...
... FbxL7 The F box, named ... was originally observed, is an approximately ... F-box proteins are components of modular ... (SKP1, cullin, F-box proteins), which function ...
Rabbit polyclonal to SERHL ( Abpromise for all tested applications). entrezGeneID: 94009 SwissProtID: Q9H4I8...
Sheep polyclonal to Staphylococcus DNase ( Abpromise for all tested applications). Antigen: Full length native protein (purified)....
Biology Products: