FDAnews Announces — Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time Webinar, July 15, 2014

There are several common mistakes in ANDA submissions that can be avoided to ensure speedy approval. Learn what those mistakes are and what to do about them on July 15 at the FDAnews webinar led by 30-year industry expert Dr. Andy Papas, Vice President of Regulatory Affairs at NSF Health Sciences Pharma Biotech.

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FDAnews

FDAnews

Falls Church, VA (PRWEB) June 24, 2014

Expedite Your FDA Generic Drug Approval:
Deliver Flawless ANDAs the First Time
**FDAnews Webinar**
July 15, 2014 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/ExpediteGenDrugApproval

There are several common mistakes in ANDA submissions that can be avoided to ensure speedy approval.

Learn what those mistakes are and what to do about them on July 15 at the FDAnews webinar led by 30-year industry expert Dr. Andy Papas, Vice President of Regulatory Affairs at NSF Health Sciences Pharma Biotech.

He'll discuss the major changes occurring due to GDUFA, share his experiences from working at the FDA, tell attendees what he's learned from hundreds of successful submissions of ANDAs and finally, show attendees how to avoid the 3 most common mistakes made in ANDA submissions — and ensure first pass approvals.

And that's just the beginning. Attendees will also leave this 90-minute webinar with specific information and details regarding:

  •     GDUFA's impact on today’s ANDA applications and how sponsors can best respond
o    How today’s 3-year approval window will become a 10-month period under FDA’s proposed plans
o    Lesser known impacts from GDUFA: facility fees, DMF completeness assessments and more

  •     The best application strategies for a large or small generic drug company, including:
o    Checking for any product-specific FDA guidances
o    Adequately addressing bioequivalence requirements ahead of time
o    Evaluating and documenting the inspection history of API and DP manufacturers (if applicable)
o    Being confident in having ensured the complete, inclusive and full drug quality information in the 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
o    How to meet the FDA's completeness, quality, and bioequivalence requirements
o    Comprehensive list of relevant and recent FDA guidances, resources, presentations, and templates for the ANDA’s administrative, bioequivalence and CMC requirements

This is a chance to take away proven, winning strategies so the generic applications will never again have to be sent through endless FDA approval cycles. Attend Expedite Your FDA Generic Drug Approval: Deliver Flawless ANDAs the First Time on July 15.

Meet the Presenter:
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.

Who Will Benefit:
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 the 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

Webinar Details:
Expedite Your FDA Generic Drug Approval:
Deliver Flawless ANDAs the First Time
**FDAnews Webinar**
July 15, 2014 — 1:30 p.m. – 3:00 p.m. EDT
[http://www.fdanews.com/ExpediteGenDrugApproval

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     [http://www.fdanews.com/ExpediteGenDrugApproval
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.