FDAnews Announces — First Cycle Approval of ANDAs: The Journey from Conception to Reality Webinar, March 23, 2016

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Are drugmakers looking forward to a one cycle approval of an ANDA, now that GDUFA II is on its way? This webinar, presented by Dr. Aloka Srinivasan, former FDA Team Leader from Office of Generic Drugs, gives an overview of how drugmakers may want to organize their ANDA to make first cycle approval a reality

First Cycle Approval of ANDAs:
The Journey from Conception to Reality
March 23, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/firstcycleapprovalandas

Are drugmakers looking forward to a one cycle approval of an ANDA, now that GDUFA II is on its way? It is a lot harder than it sounds.

This webinar, presented by Dr. Aloka Srinivasan, former FDA Team Leader from Office of Generic Drugs, gives an overview of how drugmakers may want to organize their ANDA to make first cycle approval a reality.

Dr. Srinivasan will discuss the current challenges with first cycle approval of ANDAs and how to overcome those challenges by submitting quality applications in the first place.

Attendees will get first-hand, practical information about the current standards for generic drugs based on the Generic Drug User Fee Act (GDUFA), the guidance documents published during GDUFA I, and these critical issues:

  •     Changes in requirements for Type II DMFs, promulgated by FDA, based on GDUFA
  •     Changes in requirements for ANDAs, promulgated by FDA, based on GDUFA
  •     What the generic industry would like to be the focus of GDUFA II

And then there’s the topic of complex generics. When talking complex generics, well, the key word is indeed “complex”. This webinar will include discussion on interaction with FDA in the area of complex generics, including:

  •     Complex generics and the challenges facing the industry
  •     The best ways to move forward
  •     The best ways to communicate with OGD
  •     The best ways to prepare for meetings with FDA, if granted

The bottom line: drugmakers need expert advice and guidance related to first cycle ANDA approvals and information regarding how to advance complex generics, and that’s what attendees will get from this webinar.

Meet the Presenter:
Aloka Srinivasan, Ph.D., Principal Consultant, PAREXEL

Aloka Srinivasan, Ph.D., is currently a Principal Consultant at PAREXEL International. Aloka has over 10 years of experience in FDA and other government agencies, performing scientific research and evaluating the chemistry, manufacturing, and control (CMC) sections of applications. Prior to joining PAREXEL, Aloka was a Team Leader in Office of Generic Drugs, FDA and instrumental in laying the foundation for a DMF (Type II) Review Division at CDER.

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

Webinar Details:
First Cycle Approval of ANDAs:
The Journey from Conception to Reality
March 23, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/firstcycleapprovalandas

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/firstcycleapprovalandas
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.

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Michelle Butler
FDANEWS
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