Distinguished speakers include:

  • Alastair Nixon
    Director, Submission Publishing
    GlaxoSmithKline
  • Mickel Hedemand
    Internal Advisor, Licensing Division
    Danish Medicines Agency
  • Elizabeth Bricard
    Submission Management & Customer Liaison, Global Regulatory Operations
    Sanofi Aventis
  • Pierre Géruzet
    Worldwide Regulatory Affairs
    Regulatory Operations Manager
    GlaxoSmithKline Biologicals
  • Susan Genseberger
    Head of Global Regulatory Affairs Operations
    Abbott Healthcare
  • Anna Harrington
    Director Global Regulatory Affairs APJEM Russia/CIS Country Expert
    GlaxoSmithKline

Ensure Regulatory Compliance and Successful Submissions Through Implementing Effective Data Management Strategies and Solutions

This conference is the only event of its kind to focus solely on the management of information within pharmaceutical companies, to aid regulatory submissions. The event will bring together leading professionals to focus on the regulatory aspects of data and information management.

Global pharmaceutical companies continue to compete in the strategies that they employ for the management and exchange of information, particularly with information which is critical to product development, delivery, quality, customer service, business-to-business relationships and competitive positioning. Although most regulated sectors are facing the same pressures, it is the Pharmaceutical and Biotech sector that is showing the greatest need due to the numerous commercial pressures it faces.

The need for ever evolving knowledge in the area of R&D for increased disease, biology and genetic demands means that pharmaceutical companies on average spend 10-20% of their revenues in R&D. In addition, the length of product market exclusivity, competitive pressure and rigorous regulatory procedures means that companies must carefully examine costs to increase their chances of a good return on investment. Obviously placing a key importance on the on how information is managed internally and how efficiently it is translated to the drug market applications.

In light of this and with significant feedback from the market, Pharma IQ’s has launched its inaugural Regulatory Information Management Conference. This event will enable you to benchmark your company’s strategies in how to:

  • Reduce new drug development times by implementing a centralised data storage system: Discuss which system is right for your business needs
  • Ensure compliance with external submission standards, to ensure successful submissions first time
  • Increase your product revenue by reducing time to market with a streamlined the submissions process
  • Understand the importance of how to roll out a centralised strategy and the key benefits of data centralisation

Who Should Attend:

From Pharmaceutical and Biotech Manufacturers:

  • Regulatory Affairs
  • Regulatory Data Management
  • Regulatory Information Management
  • Regulatory Operations
  • Information Technology

Regulatory Bodies:

  • Chairperson
  • Director General e-Regulatory
  • Regulatory Liaison

Key Topics Include:

  • Changing submission standards and the impact on pharmaceutical companies
  • Regulatory expectations within eCTD and submission standards
  • Practical examples of risk- based validation of submission management
  • Setting up and maintaining a global regulatory data management system
  • Coordinating global submissions: launching into emerging markets
  • Migrating the backlog of paper to an online electronic format
Sponsor Media Partners
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