This RAPS Webcast will provide an overview of the emergent Quality by Design (QbD) initiative from US Food and Drug Administration’s Office of Generic Drugs (OGD) with an emphasis on developing and gaining approval for complex drug products. OGD Deputy Director Robert (Bob) West, with more than 15 years’ experience in a variety of OGD management positions, and long-standing generic industry regulatory veteran Vincent Andolina will highlight and explain key points within the QbD initiative, such as the types of development studies that may be expected to support future drug development. These experts will emphasize the most significant points and how to apply them to OGD’s approval requirements for complex drug products with a continuous focus on timely (and therefore revenue-enhancing) reviews and approvals.
This webcast will also address the very real and at times overlooked issue of effectively communicating issues such as this within your organization. Andolina and West will provide strategies and tactics that will enhance your ability to convey the critical nature of QbD and its impact on the approval of your drug product, ultimately benefitting you and your organization.