ISI Webinar: Collaborating with Local Operating Companies on Multi-Regional Submissions

Tuesday, July 28, 2009
10:00 am EDT / 3:00 pm BST / 4:00 pm CEST

For multinational pharmaceutical companies operating in today’s formidable business climate, building worldwide brands is the ultimate goal. But navigating the cultural, economic, and regulatory differences from country to country can be daunting when launching new drugs. And the challenge is particularly pronounced during the lengthy regulatory submission phase, with each country or region guided by differing processes, formats, and requirements.

Although global collaboration and coordination between headquarters (HQ) and local operating companies (LOCs) are now critical in building submissions for multiple markets, they’ve been difficult to achieve. LOCs, which could number in the hundreds at just one multinational company, have a certain amount of autonomy and influence in their markets. What’s more, differing technology infrastructures, languages, and business processes are among the factors that have historically hindered the submission publishing solutions that get rolled out from HQ to LOCs.

Webinar Content
As we move toward global regulatory harmonization in developing and launching new drugs, HQ operations are rethinking their relationship with LOCs. To help sort through the models, an ISI regulatory expert and guest presenters from client company GlaxoSmithKline will bring forth the best practices for HQ-LOC multimarket submissions. During this Webinar you will learn both the HQ and the LOC perspectives so as to understand:

• 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
  
• The pros and cons of both a decentralized submission model and a centralized submission model
  
• What LOCs need and want from HQ in terms of tools, platforms, and resources to bring local submission activities in line with national electronic submission requirements.
  

Speakers

Moderator: Cindy van Dijk, President, van Dijk Scientific Communications

ISI Presenter: Kate Wilber, Director of Regulatory Services, ISI Europe
As Director of ISI’s European Regulatory Services, Kate Wilber helps global pharmaceutical and biotechnology companies overcome the complex EU regulatory environment to submit Marketing Authorization Applications through the Centralised, Decentralised, Mutual Recognition and National registration procedures. Kate has an extensive background in both US and EU submission filings in electronic, paper and hybrid formats. As the former Senior Global Regulatory Operations Manager at Shire Pharmaceuticals, Kate leveraged her knowledge of global regulatory affairs, software design and systems integration to direct the submission of Shire’s first EU eCTD to 11 European countries through the Decentralised Procedure. With more than a decade’s experience in electronic document management and global regulatory submissions, Kate has a keen understanding of the problems and pressures facing drug makers as they look to effectively leverage regulatory metadata standards, address training needs, and managed global submission publishing teams.

Guest Presenter: Alastair J. Nixon, Site Director of Publishing, GlaxoSmithKline
Alastair J. Nixon has filled various roles in pharmaceutical product development, including spending several years as projects manager for a transdermal drug delivery company in Oxfordshire, England. Alastair moved into regulatory consultancy in 1999, specializing in chemistry, manufacturing, and controls, and he project managed the installation of an electronic publishing system at a major contract research organization. He then spent five years in international regulatory operations at SmithKline Beecham and GlaxoSmithKline (GSK), eventually heading the international regulatory operations function. He is currently site director of publishing at GSK working with local affiliates to define the company’s eCTD strategies and capabilities across Europe. Alastair is an active member of the eCTD Topic Group at the European Federation of Pharmaceutical Industries and Associations, attends meetings of the Joint Telematics Implementation Group for Electronic Submissions, and is a member of The Organisation for Professionals in Regulatory Affairs.

Guest Presenter: Concepcion Taboas, Regulatory Affairs, GlaxoSmithKline S.A.
Concepcion Taboas is in charge of the Regulatory Systems in the Regulatory Affairs Department at GlaxoSmithKline S.A., where she directs electronic dossier submissions in the NeeS and eCTD formats. With more than a decade of experience in the clinical trial and regulatory affairs industries working with global companies such as Aventis, Abbott Laboratories and AstraZeneca, Concepcion has a keen understanding of the obstacles and opportunities presented by the transition to eCTD and the pressure to expand into a global marketplace. Concepcion was selected GSK’s European Regulatory Professional of the Year in 2007, and is a former scientific translator who speaks five European languages. As leader and coordinator of the eCTD group of the Spanish Pharmaceutical Industry Association, Concepcion is particularly qualified to discuss both the complexities of managing a diverse product portfolio in an international market and the challenges of keeping pace with the evolution of submission formats and regulatory requirements.

White Paper Offer
Following the Webinar, we will provide you with a copy of Around the World in Many Ways: Developing Models to Support Affiliate Regulatory Submissions. The report details best practices for HQ-LOC multimarket submissions, based on feedback from business leaders at large, small, and midsize biopharma companies.

 

Register for our complimentary webinar and also receive the 'Around the World in Many Ways: Developing Models to Support Affiliate Regulatory Submissions' report FREE!