Download the Agenda: 5th Annual Regulatory Writing for Product Approvals Conference

April 27-28, 2016 | Philadelphia, PA | Wyndham Philadelphia Historic District

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Join us for the 5th Annual Regulatory Writing for Product Approvals Conference April 27-28, 2016 in Philadelphia, PA! This conference will feature interactive and collaborative joint presentations with our Regulatory Operations Conference, in addition to valuable discussions of the topics most important to regulatory and medical writers.

This year, experience networking opportunities and synergistic presentations in addition to sessions with regulatory writing professionals from companies like Shire, Johnson & Johnson, and Abbvie. Take a look at what you can expect this year:

  • Valuable information regarding authorship of pediatric study reports
  • Overview and considerations for remaining compliant with EU Policy 0070
  • Data requirements for risk management plans, safety documents through to protocol writing

Check out some of the highlighted sessions:

  • Data Requirements for Pediatric Study Reports
    • Led by Madhavi Gidh-Jain, Senior Director, Global Regulatory Writing Head, Ophthotech
  • Risk Management Plans: Delivering a Balance Between Product Benefit, Safety and Risk
    • Led by Deborah Smith, Manager Medical Writer and RMP Coordinator Oncology, Johnson & Johnson
  • EU Policy 0070: Clinical Trial Data Transparency and Redactions
    • Led by Patrick Cullinan, PhD, Director, Global Clinical Trial Transparency, Takeda

 

www.q1productions.com/regwriting        |          contact: 312.602.9683          |          marketing@q1productions.com