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:3/27/2015)...   SurePure, Inc . (OTCQB: SURP), a ... the Company has completed the verification process and ... ("SURP") securities on OTCQB, an electronic quote and ... stage companies. On March 26, 2014, ... designed to improve marketplace integrity and enhance transparency ...
(Date:3/27/2015)... 27, 2015 WuXi PharmaTech (Cayman) Inc. ... capability and technology platform company serving the global ... that an Investigational New Drug (IND) application for ... arthritis has been accepted for review by the ... In September 2012, MedImmune, the global biologics ...
(Date:3/26/2015)... 26, 2015  Roka Bioscience, Inc. (NASDAQ: ... providing advanced testing solutions for the detection of ... the three months and full year ended December ... Results:Revenue for the quarter ended December 31, 2014 ... fourth quarter of 2013 and $1.5 million for ...
(Date:3/26/2015)... CO (PRWEB) March 26, 2015 The ... has formed a strategic alliance with Designing Gig LLC ... their clients. , “Forging this alliance with ... Now we can extend a comprehensive, end-to-end, digital ... development, strategy, and execution,” said Chuck Miller, president of ...
Breaking Biology Technology:SurePure Completes Verification and Approved for Trading on the OTCQB Marketplace 2Investigational New Drug Application for WuXi MedImmune's Monoclonal Antibody Accepted for Review by CFDA 2Investigational New Drug Application for WuXi MedImmune's Monoclonal Antibody Accepted for Review by CFDA 3Roka Bioscience Reports Fourth Quarter and Full Year 2014 Financial Results 2Roka Bioscience Reports Fourth Quarter and Full Year 2014 Financial Results 3Roka Bioscience Reports Fourth Quarter and Full Year 2014 Financial Results 4Roka Bioscience Reports Fourth Quarter and Full Year 2014 Financial Results 5Roka Bioscience Reports Fourth Quarter and Full Year 2014 Financial Results 6Roka Bioscience Reports Fourth Quarter and Full Year 2014 Financial Results 7The Market Element LLC and Designing Gig LLC Form Strategic Alliance 2
... , , COLUMBIA, Md., Sept. 8 ... that a panel of judges on the United States Court of ... appeal proceedings related to a patent infringement lawsuit between Martek and ... GmbH (collectively "Lonza"). The appeals involve Lonza,s U.S. sale and ...
... , PRINCETON, N.J., Sept. 8 Pharmasset, Inc. ... the Robert W. Baird & Co. Health Care Conference, Morgan ... Sciences Conference in New York, NY and the ThinkEquity G6 ... Schaefer Price, Pharmasset,s President and Chief Executive Officer, will ...
... , FORT LAUDERDALE, Fla., Sept. 8 ... in the region, launched an important joint event with the state,s ... gathered in Fort Lauderdale on August 27, to hear experts from ... of bio science and information technology. , , ...
Cached Biology Technology:Federal Circuit Rules in Martek's Favor in Appeal of Patent Infringement Case 2Federal Circuit Rules in Martek's Favor in Appeal of Patent Infringement Case 3Pharmasset to Present at Four Upcoming Investor Conferences 2Pharmasset to Present at Four Upcoming Investor Conferences 3South Florida Technology Alliance and BioFlorida Joint-Event Draws Big Names and Big Crowd 2South Florida Technology Alliance and BioFlorida Joint-Event Draws Big Names and Big Crowd 3
(Date:3/23/2015)... Inc. (NASDAQ: NXTD ) ("NXT-ID" or the "Company"), a ... announces its biometric payment technology, the Wocket® smart wallet, will ... 30 th . The new 30 ... markets. Gino Pereira , ... ad campaign following the recent initial shipment of Wocket smart ...
(Date:3/20/2015)... 19, 2015 Research and Markets ( http://www.researchandmarkets.com/research/rswjb4/hand_geometry ... - Global Strategic Business Report" report to their offering. ... Geometry in US$ Thousands. The report provides separate comprehensive analytics ... Japan , Europe , ... Rest of World. Annual estimates and forecasts are ...
(Date:3/20/2015)... 19, 2015 Research and Markets ( http://www.researchandmarkets.com/research/vkzvcs/iris_biometrics ... - Global Strategic Business Report" report to their offering. ... Biometrics in US$ Thousands. The report provides separate comprehensive analytics ... Japan , Europe , ... Latin America . Annual estimates ...
Breaking Biology News(10 mins):NXT-ID's Wocket Smart Wallet to Launch New CNBC Regional TV Ad Campaign 2NXT-ID's Wocket Smart Wallet to Launch New CNBC Regional TV Ad Campaign 3Hand Geometry - Global Strategic Business Report 2015: An Essential Security Component for both Government & Enterprise Sector 2Hand Geometry - Global Strategic Business Report 2015: An Essential Security Component for both Government & Enterprise Sector 3Hand Geometry - Global Strategic Business Report 2015: An Essential Security Component for both Government & Enterprise Sector 4Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 2Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 3Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 4Iris Biometrics - Global Strategic Business Report 2015: System & Network Access Control - A Robust Market Opportunity in the Offing 5
... of Pennsylvania School of Medicine have clarified the mechanism ... problems, in multiple animal models. The findings offer the ... bypass this issue, as reported in the April 13 ... Journal of Clinical Investigation. , "Although these results are ...
... at an alarming rate throughout Britain's coast and rivers, ... crab, brought to Britain during the last century in ... populations are not monitored and controlled, say the study's ... upon Tyne carried out the first comprehensive modelling of ...
... from the Max Planck Institite for Biophysical Chemistry ... magnetic resonance spectroscopy (solid-state NMR) with special protein ... toxins combine and change in structure. This work ... high blood pressure and many other diseases connected ...
Cached Biology News:Therapeutic prospects beyond Vioxx 2Therapeutic prospects beyond Vioxx 3Exotic crab poised for widespread UK invasion 2Exotic crab poised for widespread UK invasion 3Unraveling the mysteries of poison 2
... leader in electroporation products and specialty electrodes, ... line for experiment optimization and large volume ... breakthrough in Molecular Delivery. The days of ... typically limited the number of samples and ...
... Endogens Screening Sets contain the ... develop five colorimetric sandwich ELISA plates ... in 100 l/well of cell culture ... and Detection Antibodies, Recombinant Standard (5 ...
... Competitor Assay Kits are ideal for ... binding compounds using fluorescence polarization (FP). ... of glutathione transferase to the ligand ... [PR-LBD(GST)] and a proprietary, fluorescently tagged ...
... The organic acid analysis standard ... six organic salts; molecular weights ... This standard is provided for ... column and the organic acid ...
Biology Products: