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LATEST US REGULATORY MOVES TOWARDS FOSTERING INNOVATION: UPDATE ON MAIN NEW AND REVISED REGULATIONS AND GUIDANCE
Session Chair(s)
Jill Hartzler Warner
Associate Commissioner for Special Medical Programs, OC
FDA, United States
The FDA has been working to enhance the transparency, consistency, and efficiency of procedures applicable to combination products. This session looks at how it is helping to ensure that regulatory needs are met while lessening the burden to industry. How will the changes affect incentives for companies to market in the US versus the EU, which is tightening its requirements?
Speaker(s)
Latest US Regulatory and Policy Developments for Combination Products
Jill Hartzler Warner
FDA, United States
Associate Commissioner for Special Medical Programs, OC
Will the Regulatory Shifts in the US and the EU Make the US Market More Attractive to Innovators and the EU Less So? How Far Has the Balance Swung?
Rita M Peeters, PharmD
Johnson & Johnson, Belgium
Executive Director, Regulatory Affairs EMEA MD&D
US and Global Moves towards the Regulation of Companion Diagnostics
Peter Martin
Roche Diagnostics, Germany
Senior Director Global Regulatory Affairs RPD
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