Skip navigation
Skip navigation
You are using an outdated browser. Please upgrade your browser.

a timely webinar on the subject of multi-region submissions management, to be broadcast on July 28th

- To be broadcast later this month, the session will explore the options available to multinational pharmaceutical companies to overcome the cultural, economic and regulatory differences when launching new drugs in multiple countries -

Eschborn, Germany – July 20th, 2009 – Image Solutions Inc. (ISI), a leading provider of electronic submissions management and publishing solutions for the life sciences community, has announced a timely webinar on the subject of multi-region submissions management, to be broadcast on July 28th.

The session, Collaborating with Local Operating Companies on Multi-Region Submissions, will acknowledge and address the cultural, economic and regulatory differences between countries, which can prove so daunting when launching new drugs. Recognising that the challenge is particularly pronounced in the lengthy regulatory submissions phase, with each country or region guided by differing processes, formats and requirements, the webinar will outline optimum strategies and solutions for overcoming these complexities. Suggested approaches include developing a centralised strategy which harnesses the unique local knowledge of local operating companies (LOCs), while overcoming local technology differences.
Webinar details

Title: Collaborating with Local Operating Companies on Multi-Regional Submissions
When: Tuesday, July 28, 2009|10:00 am EDT / 3:00 pm BST / 4:00 pm CEST

Webinar content
As the market moves towards global regulatory harmonisation in developing and launching new drugs, HQ operations are rethinking their relationship with LOCs. To help sort through the models, a regulatory expert from ISI, and guest presenters from customer GlaxoSmithKline (GSK), will outline the best practices in HQ-LOC multi-market submissions.

The webinar will provide both the HQ and LOC perspectives, to provide a deeper understanding of:
• How the relationship between HQ and LOCs has changed in the current business climate, and why LOCs are more important than ever in global regulatory filings
• What LOCs need and want from HQ in terms of tools, platforms and resources to bring local submissions activities in line with national electronic submission requirements

Speakers

• Facilitator: Cindy van Dijk, President, van Dijk Scientific Communications
• ISI Presenter: Kate Wilber, Director Regulatory Services, ISI Europe
• Guest Speaker: Alastair J. Nixon, Site Director of Publishing, GlaxoSmithKline
• Guest Speaker: Concepcion Taboas, Regulatory Affairs, GlaxoSmithKline S.A.

Registration
Click here to learn more and registration for the webinar

About Image Solutions, Inc.

Founded in 1992, Image Solutions, Inc (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organisations as well as the top companies in other regulated industries.

ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognised charitable organisations. For more information, visit the company website at www.imagesolutions.com.

PR Contact:

Carina Birt, Sarum
PR for ISI
carina@sarumconsultancy.co.uk
+44 1722 411150

This press release was distributed by ResponseSource Press Release Wire on behalf of Sarum Consultancy in the following categories: Business & Finance, Medical & Pharmaceutical, Computing & Telecoms, for more information visit https://pressreleasewire.responsesource.com/about.