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PDUFA/UFA Audiosynchronized Presentations


Purchase Both Conferences for Only $499!

In Fall 2012 DIA, along with FDA and the Food & Drug law Institute (FDLI), hosted Unwrapping FDA’s 2012 UFA Package: What’s Inside the Statute, What’s Next? and DIA/FDA Industry PDUFA V Conference in Washington, DC. If you missed these two conferences, you can now purchase synchronized audio recordings and PowerPoint slides. Individual sessions are also available.

From the comfort of your home or office, you can:

  • Gain a better understanding of the specific provisions of PDUFA V, MDUFA III, GDUFA, and BsUFA
  • Receive critical information on how the newly enacted UFAs will affect the industry's ability to develop new medical products
  • Hear FDA, industry, patient, consumer, and healthcare professional groups and technology vendors discuss the key PDUFA V commitments, current plans for their implementation, and potential impact  

 
Unwrapping FDA’s 2012 UFA Package: What’s Inside the Statute, What’s Next? Presented by DIA and FDLI Unwrapping FDA’s 2012 UFA Package: What’s Inside the Statute, What’s Next?
In collaboration with FDLI

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Multiple Sessions!
Session, Keynote/Closing Plenary (Free with each purchase)
Session: $99 | Complete Package: $249

Hear FDA discuss the goals and commitments for their Centers, the changes of emphasis, and the potential impact on future programs. Reactor panels provide the exchange of views on what the UFA provisions will mean for innovation, how they will improve patient access to needed medical products over the next five years, and next steps in preparing for 2017.
 

    PDUFA, GDUFA, and BsUFA Highlights
 

    MDUFA Highlights
 

    Beyond Review Management: Regulatory Science, Enhanced Communications and Transparency
 

    Enhanced Drug Development: Accelerated Approval, Greater Access to Experts, Pediatrics, Breakthrough Therapies, GAIN/Antibacterials

    FDASIA Provisions to Enhance Drug Development: Drug Shortage and Supply Chain
 

    Other Device Reforms
 


 
DIA/FDA Industry PDUFA V Conference

DIA/FDA Industry PDUFA V Conference

In collaboration with FDA

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Multiple Sessions! Session and Keynote (Free with each purchase): $99 | Complete Package: $349

FDA, industry, patient, consumer, and healthcare professional group representatives, discuss the key PDUFA V commitments, current plans for their implementation, and potential impact on all stakeholders.

Keynote Address included with purchase of session(s)!
 

    New Review Program for NME NDAs/Original BLAs and Enhanced Communication between FDA and Sponsors during Drug Development 

    Enhancement and Modernization of the FDA Drug Safety System in PDUFA V
 

    Structured Benefit-Risk Assessment in Regulatory Decision Making, Patient-Focused Drug Development, and Advancing the Use of Patient Reported Outcome (PRO) Measures

    Efficiency of Human Drug Review through Required Electronic Submissions
 

    Regulatory Science Enhancements: Meta-analysis, Pharmacogenomics and Biomarkers, and Rare Diseases
 

    Standardization of Electronic Drug Application Data: A Critical Factor in Improving the Effectiveness and Efficiency of the Regulatory Review Process

    Ensuring the Success of PDUFA V: FDA, Industry, and Stakeholder Perspectives