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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Resources, news and special offers to support you and your professional development during this difficult time.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Download your copy of the new events calendar and see all the online workshops, conferences, RAC exams and European online workshops RAPS has planned for 2021 at a glance.
An invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation
From self-assessments to help you identify your strengths and areas to focus on to reference books and online courses that will help you fill in the gaps in your regulatory knowledge, RAPS has the resources to help you prepare for the RAC exam.
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Members: $10 (USD)Non-members: $25 (USD)
Description
Anyone working in biotech knows the often-immense challenges our industry faces with drug shortages. In 2019, FDA’s inter-agency Drug Shortages Task Force published a report entitled, Drug Shortages: Root Causes and Potential Solutions. The number of drug shortages has been increasing, lasting longer, and been a persistent healthcare problem despite efforts to prevent and mitigate these issues. The impact on patients of these shortages is substantial. Understanding the regulatory leader’s role in managing these crises may help prevent and mitigate the impact of drug shortages. A Global Regulatory Lead from Jazz Pharmaceuticals will share his experiences, challenges faced with drug shortages, and recommendations from a regulatory perspective.
A separate challenge that the biotech industry often faces is manufacturing issues for biologics that traditionally do not arise when manufacturing small molecules. Understanding the CMC regulations for biologics and the regulatory leader’s role in addressing these manufacturing challenges are important aspects of drug development. A Global Regulatory CMC Lead from Jazz Pharmaceuticals will describe her experiences with complying with the CMC Regulations for biotech products compared to those for small molecules.
The webcast will conclude with a Q&A session.
This event is brought to you by the RAPS San Francisco Bay Area chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credits.
How Do Webcasts Work?
For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation.
Featured Speakers:Jonas Wilf, director, global regulatory lead, Global Regulatory Strategy, Jazz Pharmaceuticals, Inc.Vijaya Kuppa, senior manager, Global CMC Regulatory Strategy, Jazz Pharmaceuticals, Inc.
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.
Photo Release: By registering for this program, you acknowledge that your picture may be taken by RAPS agents and consent to the use of your name and likeness by RAPS for any RAPS use as deemed appropriate by the organization.
Cancellation Policy: Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at support@raps.org.