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:

  • Building the business case for assigned budget
  • Risk assessment when implementing data management systems
  • Centralising your data management systems
  • Ensuring compliance with data privacy regulation
  • Enabling and effective submissions process
  • Ensuring compliance to data management standards
  • Adhering to label management regulation
  • Assessing existing systems compatibility with new technologies

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