Impact of GDUFA Performance Metrics on ANDA Approval Times - Webinar CD/Transcript

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Impact of GDUFA Performance Metrics on ANDA Approval Times: Opportunities, Risks and Practical Considerations

Generic drugmakers: You have until OCT. 1 to be GDUFA-ready. Help is at hand. Read this NOW.

For generic drugmakers, Oct. 1 is Crunch Time — the date after which all your ANDA amendment and prior-approval supplement applications must meet new performance goals under the Generic Drug User Fee Amendments (GDUFA) of 2012.

We’ve enlisted the assistance of Lachman Consulting’s Joan Janulis, a Hatch-Waxman pro and all-around expert on FDA regulation in the generic drug industry. She’ll help you read between the lines of the GDUFA performance metrics, associated guidance documents and MAPPs, and provide a roadmap to the post-GDUFA paradigm.

But make no mistake: this session is about much more than theory and abstraction. You’ll discover concrete examples that illustrate what ANDA sponsors can expect — and must prepare for.

In 90 fast-paced minutes, Ms. Janulis takes you from the big picture to nuts-and-bolts implementation. Here’s a point-by-point summary of what she’ll cover:

  • Understanding how overarching GDUFA performance goals relate to ANDA reviews
  • Identifying ANDA applications not subject to statutorily prescribed performance goals and how the FDA will handle these
  • Impact of ANDA amendments (not to be underestimated!)
  • Strategic opportunities and concealed risks associated with GDUFA
  • “Standard industry practices” that could trip you up in the new GDUFA era
  • Show-and-tell based on Lachman Consultants’ experience that steer you to higher application success rates under the new guidances
  • And much more

With time so short before GDUFA full implementation, every second of advance preparation pays off in faster drug approvals and fewer hassles. Don’t mess with the FDA … or your company’s well-being.

  • Executive management
  • R&D
  • Regulatory affairs
  • Manufacturing/operations/supply chain management
  • QA/QC

Joan Janulis is Vice President and Regulatory Affairs Practice Head for Lachman Consultants, a pharmaceutical consultancy known for its expertise in the generic pharmaceutical space. Ms. Janulis is an authority on development, regulatory approval and post-approval lifecycle management of generic drugs, and boasts extensive knowledge of Hatch Waxman legislation and other FD&C Act amendments affecting generics. A 20-year veteran of the pharmaceutical industry, she has experience at Purepac Pharmaceuticals, F.H. Faulding and Co., IVAX Pharmaceuticals and Alpharma Inc. developing strategies to cut ANDA approval times and achieve favorable market entry position for new product launches.