San Francisco Bay Area Chapter: Considerations in the Development Lifecycle of Oncology Drugs from a Global Regulatory Perspective

2.0
RAC Credits
Thursday, 10 October 2019 (5:30 PM) - Thursday, 10 October 2019 (8:30 PM)
1500 Seaport Blvd
Redwood City, California, USA, 94063-5540

*Student: $25
Member: $35
Nonmember:  $45

 *Fax/email in a completed registration form to get the student rate.

Oncology therapeutics are typically evaluated based on their ability to control the growth of a tumor or extend life. Considering all available product development and regulatory avenues to increase speed to market across the globe for promising therapies is critical to advancing therapeutics and meeting critical unmet needs for patients.

Join others from your local regulatory community to hear how the regulatory team at AbbVie gets involved very early in product development and provides support for its products from molecule nomination through global regulatory approval and commercialization. Adequately preparing globally for clinical trial design, anticipated core claims, labeling, global label negotiations, launch readiness and global advertising and promotion starts early in the development lifecycle.

The presentations will explore the role of regulatory affairs and cross functional collaboration throughout the product development lifecycle that is applicable to not only large organizations, but small organizations with a single regulatory function pursuing the development of novel oncology drugs. The speakers will share how their regulatory teams balance the need for processes, agility, timely decision making, training, and communication in how they manage projects across the globe and will share key learnings to develop products in a global product development environment.

This program, hosted by AbbVie Inc., is brought to you by the RAPS San Francisco Bay Area chapter and is intended to provide professional development and networking opportunities for those in the local regulatory community.  A light meal will be available for all attendees and RAC holders may claim two RAC recertification credits.

Featured speakers:
Nina Grove, MA, MPH, director, international regulatory advertising and promotion, AbbVie Inc.
Lisa Wax, senior director, global regulatory affairs, oncology early development, AbbVie, Inc.