The Drug Information Associates (India) has teamed up with US FDA and Pharmexcil to organize a series of workshops on 'Generic Drug Applications' at four locations across the country. The day-long workshop will be held in Mumbai on April 30, in Hyderabad on May 2, in Goa on May 4 and in Chandigarh on May 7, 2012.
The primary focus of this workshop is to brief the small, medium and large scale pharmaceutical firms in India on filing Abbreviated New Drug Applications (ANDAs) with the US FDA. The workshop will address the on-going initiative of Quality by Design (QbD) that can be implemented in the pharmaceutical development of generic drug products. Having this understanding will help both generic applicants and the agency in bringing quality generic products expeditiously to the market, according to the organizers.
In identifying this need for common understanding within Indian pharmaceutical firms, the workshop will be conducted on April 30 at the SciTech Centre, Mumbai. On May 2 it will be held at the Vivanta by Taj, Hyderabad. On May 4 it will be at Vivanta by Taj, Goa and on May 7 at the Lemon Tree, Chandigarh.
There will also be a one-on-one interaction with two senior US FDA staff members from the Office of Generic Drugs (OGD). They will share valuable information with participants on US FDA’s expectations for QbD, and how QbD will impact pharmaceutical development, ANDA submissions and future interaction with the US FDA.
There will be an overview at the start of the workshop followed by three detailed sessions, during which participants will learn the meaning and expectations of terms used, such as “product design” and understanding and process design and understanding. In the afternoon session of the workshop, control strategies will be discussed. At each one-day workshop, US FDA staff from OGD will be available for a Q&A session in order to update applicants on recent issues, as requested.
These workshops are important to the US FDA, DIA and Pharmexcil as they further the mission of disseminating important US FDA regulatory information regarding drug application criteria to the industry, stated the organizers.
The key presenters are Dr Lane Christensen, Science Staff, Office of Generic Drugs (OGD) US FDA and Dr Vilayat A Sayeed, division director, Office of Generic Drugs (OGD), US FDA.
The workshops will cover Quality by Design: Overview and Quality Target, Product Design and Understanding, Process Design and Process Understanding &Control Strategy and Risk Assessment, & Design of Experiments.