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

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:

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

Karen Lim (416) 977-6555 ext 227

Read the full story at

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

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:
(Date:11/25/2015)... Francisco, CA (PRWEB) , ... November 25, 2015 ... ... microbial genomics company uBiome, were featured on AngelList early in their initial angel ... launching an AngelList syndicate for individuals looking to make early stage investments in ...
(Date:11/24/2015)... -- Cepheid (NASDAQ: CPHD ) today announced that ... and invited investors to participate via webcast. ... 1, 2015 at 11.00 a.m. Eastern Time --> ... 1, 2015 at 11.00 a.m. Eastern Time --> ... NY      Tuesday, December 1, 2015 at 11.00 ...
(Date:11/24/2015)... ... November 24, 2015 , ... Copper is ... it is bound to proteins, copper is also toxic to cells. With a ... Polytechnic Institute (WPI) will conduct a systematic study of copper in the bacteria ...
(Date:11/24/2015)... -- Clintrax Global, Inc., a worldwide provider of clinical research services headquartered ... the company has set a new quarterly earnings record in Q3 ... posted for Q3 of 2014 to Q3 of 2015.   ... , with the establishment of an Asia-Pacific ... United Kingdom and Mexico , with ...
Breaking Biology Technology:
(Date:10/29/2015)... October 29, 2015 NXTD ... company focused on the growing mobile commerce market ... that StackCommerce, a leading marketplace to discover and ... Wocket® smart wallet on StackSocial for this holiday ... or the "Company"), a biometric authentication company focused ...
(Date:10/27/2015)... , Oct. 27, 2015 Synaptics Inc. (NASDAQ: ... today announced that Google has adopted the Synaptics ® ... controller solutions to power its newest flagship smartphones, the ... Huawei. --> --> ... Google to provide strategic collaboration in the joint development ...
(Date:10/23/2015)... DUBLIN , Oct. 23, 2015 Research ... of the "Global Voice Recognition Biometrics Market 2015-2019" ... --> --> The global voice recognition ... during 2014-2019. --> ... 2015-2019, has been prepared based on an in-depth market ...
Breaking Biology News(10 mins):