GENERIC
DRUG REGISTRATION
Preparing for Successful Submissions in the
New Millenium
December 13 - 14, 1999
The Ritz Carlton, Pentagon City Arlington, VA
Since the FDA anticipates a dramatic increase of ANDA submissions over the next decade, it is critical for the application process to proceed as expeditiously as possible in order to remain competitive in the market. Each year, an average of 10 pioneer drugs loses their patent protection. This virtually elimiates their market exclusivity and thereby opens the door for generic alternatives. Attention to this area is expected to rise based on the number of important patent expirations along with the increased focus on health-care cost containment.
The FDA has increased its effort in ensuring that the generic products are indeed meeting the reqeuired standards. Any insufficient or inaccurate data ultimately delays the approval process. Timing therefore, becomes a critical factor. Electronic generic drug submissions are gaining precedence in resolving this issue. When properly executed, this process can expedite the evaluation and review process. If not, it can greatly hinder the review causing delays to market. Lastly, bioavailability and bioequivalence continue to be one onf the most important issues for approval. Proper study execution and documentation are key to the successful approval of the application.
This program has been specifically designed to address the challenges and concerns facing generic drug submissions and avoiding pitfalls. We provide hands-on examples of how to execute successful ANDA submissions for generic products.
Day One comprises a practival course covering all aspects of FDA filing.
Day Two includes a variety of current topics affecting generic products.
Our seminar leaders bring years of expertise to the table. Together they provide you with information on the guidelines and processes used to file generic drug submissions.
- Understanding FDA guidelines and requirements
- Determining what data is needed to support the ANDA
- Exploring electronic submission documentation for bioequivalence studies
- Reviewing the latest developments of SUPAC and IVIVC
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