Navigation Links
Early Opportunities to Set the Course for Successful Global Marketing Authorization, New Life Science Webinar Hosted by Xtalks

Toronto, Canada (PRWEB) September 13, 2013

Early planning of your marketing authorization strategy is crucial to the development of a comprehensive dossier filing and to avoiding potential delays or refusal to file down the line.

While achieving global marketing authorization approval is one of the end goals of the product development process, many companies don’t start considering their marketing application strategy until well into their Phase III program, losing out on opportunities to save time and help ensure accuracy downstream.

Common challenges and pitfalls that companies face as a result of gaps in planning their marketing authorization strategy early on may include a failure to understand global, regional, and local requirements for filing or a suboptimal presentation and analysis of data.

In this webinar, esteemed biostatistics and regulatory affairs professionals will share their insights on how to plan ahead, avoid costly delays and deal with quality issues. More specifically, speakers will cover how to: interpret the best landscape for a particular dossier; assessing the history of the compound; conduct a gap or SWOT analysis of the dossier, in addition to other key considerations

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. Netsmart Clients to Receive Nearly $2 Million in Meaningful Use EHR Incentive Payments
2. Access BridgeGap Ventures to Focus on Early-Stage Therapeutic Opportunities
3. VisionGate Uses $2.6 Million NIH Grant to Achieve Full Automation of Cell-CT™ 3D Imaging System for Early Diagnosis of Cancer
4. Sequenom Announces 2011 Operational Highlights and Early 2012 Outlook
5. CSL Behring Study Confirms Early Treatment with Berinert® Provides Faster Resolution of Acute Hereditary Angioedema Symptoms
6. Corporate Venturing and Early-Stage Financing in the Spotlight at BioTrinity
7. Butamax Early Adopters Group surpasses capacity targets with addition of Big River; Membership represents 11 production facilities and nearly 900 million gallons of ethanol capacity
8. Researchers peek at the early evolution of sex chromosomes
9. Discuss Early Results of the DIAN Trial at CBIs 6th Annual Alzheimers Drug Development Summit
10. Early career distinction: Prestigious award recognizes physicists work in electron dynamics
11. JCI early table of contents for Sept. 4, 2012
Post Your Comments:
(Date:11/26/2015)... , England , November 26, 2015 ... Lightpoint Medical, an innovative medical device company specializing in imaging ... grant from the European Commission as part of the Horizon ... the company to carry out a large-scale clinical trial in ... -->      (Logo: , --> ...
(Date:11/25/2015)... HOLLISTON, Mass. , Nov. 25, 2015 ... a biotechnology company developing bioengineered organ implants for life-threatening ... will present at the LD Micro "Main Event" investor ... PT. The presentation will be webcast live and posted ... also be available at the conference for one-on-one meetings ...
(Date:11/25/2015)... 25, 2015 The Global ... a professional and in-depth study on the current ... (Logo: ) , The ... including definitions, classifications, applications and industry chain structure. ... international markets including development trends, competitive landscape analysis, ...
(Date:11/24/2015)... Therapeutics, Inc. (NASDAQ: HALO ) will be presenting at the ... on Wednesday, December 2 at 9:30 a.m. ET/6:30 a.m. PT . ... a corporate overview. th Annual Oppenheimer Healthcare Conference ... a.m. PT . Jim Mazzola , vice president of ... --> th Annual Oppenheimer Healthcare Conference in ...
Breaking Biology Technology:
(Date:11/12/2015)... , Nov. 12, 2015  Arxspan has ... of MIT and Harvard for use of its ... information management tools. The partnership will support the ... biological and chemical research information internally and with ... be used for managing the Institute,s electronic laboratory ...
(Date:11/9/2015)... ) ... "Global Law Enforcement Biometrics Market 2015-2019" ... ) has announced the addition of ... 2015-2019" report to their offering. ... ) has announced the addition of the ...
(Date:10/29/2015)... 2015  The J. Craig Venter Institute (JCVI) policy ... and Biosecurity: Lessons Learned and Options for the Future," ... Human Services guidance for synthetic biology providers has worked ... --> --> Synthetic biology promises ... to pose unique biosecurity threats. It now is easier ...
Breaking Biology News(10 mins):