Expedite Your FDA Generic Drug Approval

Expedite Your FDA Generic Drug Approval - Webinar CD/Transcript

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Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time

There are several common mistakes in ANDA submissions that you can avoid to ensure speedy approval.

Learn what those mistakes are and what to do about them with the webinar CD and transcript set led by 30-year industry expert Dr. Andy Papas, Vice President of Regulatory Affairs at NSF Health Sciences Pharma Biotech. 

He discusses the major changes occurring due to GDUFA … shares his experiences from working at the FDA … tells you what he's learned from hundreds of successful submissions of ANDAs … and finally, shows you how to avoid the 3 most common mistakes made in ANDA submissions — and ensure first pass approvals.

And that's just the beginning. You'll also get specific information and details regarding:

  • GDUFA's impact on today’s ANDA applications and how sponsors can best respond
    • How today’s 3-year approval window will become a 10-month period under FDA’s proposed plans
    • Lesser known impacts from GDUFA: facility fees, DMF completeness assessments and more
  • The best application strategies within your control — whether you're a large or small generic drug company, including:
    • Making sure you’ve checked for any product-specific FDA guidances
    • Assuring you’ve adequately addressed bioequivalence requirements ahead of time
    • Evaluating and documenting the inspection history of API and DP manufacturers (if applicable)
    • Being confident you have ensured the complete, inclusive and full drug quality information in your ANDA application — including a thorough review of Module 2 against FDA’s QbR guidance
  • Best practices to ensure the best quality, most comprehensive ANDA submission
    • How to meet the FDA's completeness, quality, and bioequivalence requirements
    • Comprehensive list of relevant and recent FDA guidances, resources,  presentations, and templates for the ANDA’s administrative, bioequivalence and CMC requirements

This is your chance to take away proven, winning strategies so your generic applications will never again have to be sent through endless FDA approval cycles. 

Pharmaceutical companies and professionals looking to understand today’s increased US regulatory requirements for generic drug approvals in the US, the impact of the recent approval of GDUFA, and how to avoid deficiencies in your pivotal ANDA submission, particularly regarding the Quality and Bioavailability/Bioequivalence requirements. Including:

  • Submission and applications specialists
  • Strategic planning and lifecycle management specialists
  • Executive management
  • General/corporate counsel
  • Personnel new to the industry
  • Regulatory professionals
  • Consultants/service providers

Dr. Andy Papas, PhD, MBA, RAC serves as the Vice President of Regulatory Affairs at NSF Health Sciences Pharma Biotech.  He has over 30 years of experience, including eleven years of regulatory experience at the FDA, nine years in the pharmaceuticals and biologics regulatory industry, and ten years as a research scientist. His areas of expertise include Regulatory Affairs, CMC, and marketing applications (NDA, BLA, ANDA, PMA, etc.) for a wide variety of pharmaceuticals, biologics and combination products. 

NSF Health Sciences Pharma Biotech is at the leading edge of regulatory and compliance issues for the pharmaceutical, biologics and biotech industries. Its unique team of ex-FDA regulatory and inspectional professionals provides consulting that is authoritative and respected by major pharma companies and regulatory agencies around the globe. With subject matter experts in a broad range of pharmaceutical product types, including US ANDA submissions, NSF can provide expert advice across the product lifecycle, from development through registration and to technical transfer, manufacture and eventual discontinuation.