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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
In this webcast, experts will present an analysis of FDA's accelerated approvals program, the development strategies that paved the way for these approvals and their outcomes. Currently a hot topic within the biopharmaceutical industry, there are growing concerns regarding the overall premises of the program and its exhaustiveness.
This session will cover a comprehensive analysis of the program. Join us to take a deep dive into past models and much more.
After this program, participants will be able to:
Sheila is a regulatory affairs professional with 13 years of healthcare industry experience including in regulatory intelligence, database management and quality assurance. She has led operational teams with a focus on developing and implementing regulatory strategies, corporate policies and initiatives to promote and ensure compliance with international regulations. Sheila is a BS graduate in Chemistry from the Autonomous University of Barcelona and holds an MS in Pharmaceutical research, development and control from the University of Barcelona.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing to firstname.lastname@example.org. RAPS is unable to accept cancellations by phone.
To transfer a registration, email email@example.com with the event title, name of the original registrant and the contact information for the new attendee.
For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-helpFor account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email firstname.lastname@example.org.