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 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/2013/10/prweb11257924.htm.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... 27, 2016 /PRNewswire/ - BIOREM Inc. (TSX-V: BRM) ("Biorem" or ... its major shareholders, Clean Technology Fund I, LP and ... based venture capital funds which together hold ... a fully diluted, as converted basis), that they have ... entire equity holdings in Biorem to TUS Holdings Co. ...
(Date:6/27/2016)... , ... June 27, 2016 , ... Parallel 6 ... trials, announced today the Clinical Reach Virtual Patient Encounter CONSULT module which ... with the physician and clinical trial team. , Using the CONSULT module, patients and ...
(Date:6/27/2016)... , June 27, 2016  Liquid Biotech ... the funding of a Sponsored Research Agreement with ... tumor cells (CTCs) from cancer patients.  The funding ... CTC levels correlate with clinical outcomes in cancer ... data will then be employed to support the ...
(Date:6/24/2016)... DIEGO , June 24, 2016 ... more sensitively detects cancers susceptible to PARP inhibitors ... circulating tumor cells (CTCs). The new test has ... HRD-targeted therapeutics in multiple cancer types. ... targeting DNA damage response pathways, including PARP, ATM, ...
Breaking Biology Technology:
(Date:5/12/2016)... WearablesResearch.com , a brand of Troubadour Research & ... Q1 wave of its quarterly wearables survey. A particular ... a program where they would receive discounts for sharing ... "We were surprised to see that so many ... CEO of Troubadour Research, "primarily because there are segments ...
(Date:5/3/2016)... , May 3, 2016  Neurotechnology, a provider ... MegaMatcher Automated Biometric Identification System (ABIS) , ... multi-biometric projects. MegaMatcher ABIS can process multiple complex ... any combination of fingerprint, face or iris biometrics. ... SDK and MegaMatcher Accelerator , which ...
(Date:4/28/2016)... , April 28, 2016 First quarter ... (139.9), up 966% compared with the first quarter of 2015 ... totaled SEK 589.1 M (loss: 18.8) and the operating margin was ... (loss: 0.32) Cash flow from operations was SEK 249.9 ... 2016 revenue guidance is unchanged, SEK 7,000-8,500 M. The ...
Breaking Biology News(10 mins):