May 14-15, 2012 | Baltimore, MD

ABOUT THE CONFERENCE

In today’s industry, with the demand for getting new submissions quickly approved by regulatory agencies to ensure an expedited time to market for new products, pharmaceutical and biotechnology executives are continually evaluating the efficiency and quality of their medical writing and regulatory operations. The amount of clinical data and supporting evidence that is required to complete a regulatory submission is quite staggering and it is the responsibility of the medical writers and submission specialists to ensure that the data is properly translated, formatted, and compiled for regulatory reviewers. Also, the use of e-CTD, the only accepted form of submission by the FDA as of 2008, has placed greater scrutiny upon the quality level of technical writing for all supporting documents and the margin of error in compiling these documents has become far narrower with the use of e-submissions.

With regulatory agencies increasing their level of scrutiny on product approvals and company executives are pushing for early product launches, it is imperative for medical writers and regulatory operations to have a thorough understanding of key FDA requirements and deadlines ensuring approval for all new products. This program will highlight industry leaders in regulatory writing and submissions management, who as presenters will share their experiences and knowledge which will be of great benefit to all attending delegates. This comprehensive two-day conference program is focused on bring key industry leaders and executives together to network, knowledge share, and openly discuss the challenges that they face on a day to day basis when preparing regulatory submission documents and to share new ideas on how to best optimize the regulatory writing and submissions process.

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TOPICS TO INCLUDE:

• Utilizing Effective Planning Practices to Create a Clear Organization Framework for Submission Processes
• Writing and Formatting Best Practices for NDAS, INDS, and BLAS
• Analyzing the Importance of Open Communication between Regulatory Writers and Medical Teams
• Overview of Current ICH Submission Standards and Their Impact on the Industry
• Balancing the Workflow and Tracking of Simultaneous Product Approval Submissions
• Leading Strategies for Managing Multiple Authors to Ensure Dossier Cohesiveness
• Developing International Regulatory Approval Submissions Dossiers Through the Use of Bridging Reports
• Successes, Pitfalls, and Lessons Learned When Adopting and Transitioning To E-CTD Submissions
• Creating Compliant Submission Templates to Ensure Proper Document Formatting
• Planning Process of Simultaneous Global Submissions
• Establishing and Maintain Thorough Document Management Practices
• Best Practices In Communication and Collaboration between Regulatory Writers and Submission Specialists
• Employing Effective E-CTD and E-Submission Validation Practices
• Defending Product Submissions to Regulatory Agencies

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KEY PRESENTERS TO INCLUDE:

Justina A. Molzon
Associate Director for International Programs
CDER, FDA

Cynthia Gates
Regulatory Medical Writer
Biogen Idec

Kelley Hill
Associate Director, Medical Writing
Shire

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