RAC (US) Instructor-Led Online Course

During this instructor-led, planned course of study, you will participate in 16 weekly live regulatory webinars as you prepare to take the RAC (US) exam. Using the Fundamentals of US Regulatory Affairs book, with real-world examples and practical applications provided by regulatory experts, this course provides opportunities to work in small, virtual study groups, and three review sessions. All live webinars are recorded for post-presentation review, and a practice exam is included with the course. This is a high-engagement program with interactive activities and practical applications woven into the course using several learning and study formats. You will have use of all the following:

  • 16 weeks of structured, instructor-led lessons in a virtual classroom setting
  • All 16 sessions recorded for your convenience and easy access
  • Fundamentals of US Regulatory Affairs book (hardcover)
  • US Regulatory Acronyms & Definitions book (hardcover)
  • Expert facilitators with RAC (US) designation
  • Virtual study groups
  • Review sessions
  • RAC (US) practice exam
  • Study checklist
  • US exam content outline

Important Notices:

  • RAPS does not state or imply that RAC preparation materials provided by RAPS is the best or only means for preparing adequately for the RAC exam.
  • No advantage is given to candidates who participate in preparation studies provided by RAPS over candidates who choose to prepare using any other material or method.
  • The use and purchase of preparation courses and materials is optional.
  • RAPS and the RAC (US) Instructor-Led Online Course does not state or imply that this education or training program is the only or preferred route to certification.
  • Passing the RAC (US) exam is a requirement to receive the RAC (US) designation. Attending and participating in this study course does not guarantee a passing grade on the RAC (US) exam.




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Faculty
  • Registration Info
  • Cancellation

At a Glance

Date:

Weekly, Tuesdays, 4 January–13 April 2017 (3:30-5:00 pm EST)
Review Session Dates: 16 February, 9 March and 6 April

Meeting Location:

Virtual classroom with online access

Registration Closes:

22 December 2016

Refund Deadline:

13 January 2017

RAC Credits:

None

Will the webcasts be recorded?

Yes

Proof of Attendance:

An electronic letter of attendance will be sent upon request.

Registration Fees:

RAPS Members: $1,450
Nonmembers: $1,550

Copyright:

Copyright © 2016 by the Regulatory Affairs Professionals Society (RAPS)

RAC preparatory materials are protected under United States Copyright laws, 17 U.S.C.A. §101, et seq., international treaties, and corresponding laws of other jurisdictions. No part of the RAC preparatory materials may be reproduced, distributed, shared, or disseminated in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without prior written permission from RAPS. 

 

Objectives

At the conclusion of this workshop, participants:

  • Will have a firm understanding of the regulatory profession
  • Will have completed a structured study program to prepare for the RAC (US) exam
  • Will distinguish between application, analytical and recall test questions
  • Will develop insights from other course attendees by participating in small study groups
  • Will use critical thinking skills to apply fundamental regulatory information
  • Will have attended 16 live, or recorded, webinars taught by 20 regulatory experts
  • Will apply regulatory concepts to real-world scenarios
  • Will understand common test-taking tips used in preparing to take the RAC (US) exam
  • Will complete a to-do checklist in order to meet RAC guidelines

Who Should Attend

The course is intended for regulatory professionals who:

  • Have three or more years of regulatory experience
  • Have a strong interest in obtaining the RAC designation
  • Want to build a strong knowledge base in regulatory

Content is intended for those who are interested in learning about concepts associated with each topic. Class discussions and print materials provide supplemental information and aide in the understanding and development of regulatory knowledge. Case studies, scenarios and study groups will be employed during the course. Student engagement is highly encouraged.

Agenda

Check out the program overview (PDF).

Faculty


Anjali Atal-Gupta, RAC (US), regulatory affairs manager, Stryker
Lisbert Avila-Yu, RAC (US), regulatory affairs associate director, BSI Group
Nikit Bhatt, BS, MS, RAC (US), senior scientist, CMC Preformulation Group, Ferring Pharmaceuticals
Sandra Binns, RAC (US), director of regulatory affairs, Glaxo Smith Kline
David Brindley, DPhil, MEng, FRSA, professor, the University of Oxford
Meredith Brown-Tuttle, RAC (US), FRAPS, vice president, regulatory and quality, Lyric Pharmaceuticals Inc.; CEO, Regulatorium
MaryEllen Dronitsky, director, regulatory affairs, advertising and promotions, Sanofi Genzyme
Selina Feng, MBS, RAC (US), regulatory affairs specialist, Athenex Inc.
Joy Frestedt, PhD, RAC (US), CPI, FRAPS, president and CEO, Frestedt Incorporated
Treena Jackson, RAC (US), quality assurance supervisor, RTI Health Solutions
Kurt Karst, JD, attorney, Hymen, Phelps & McNamara, P.C.
Julia Kim, RAC (US), director of regulatory affairs, Glaxo Smith Kline
Nicole Landreville, PEng, RAC (US), FRAPS, program manager, DGS women’s health and lunar regulatory affairs, GE Healthcare
Nisha Pandya, RAC (US), associate director, Johnson & Johnson
Mitchell Parrish, JD, RAC (US), vice president of legal affairs, Kinetiq
Anthony Schiavone, JD, legal counsel, Philips Healthcare
James Smith, DPhil candidate, the University of Oxford
Dipali Varia, MS, RAC (US), regulatory affairs associate, Heritage Pharmaceuticals Inc.
Melissa Walker, RAC (US), president and CTO, Graematter
Martha Wells, MPH, RAC (US), vice president of regulatory affairs for tissue and biologics, Dohmen Life Science Services
Andrew Zeltwanger, MS, director of regulatory and quality, Rinovum Women's Health LLC

 

Registration Info


RAPS Members:  $1,450
Nonmembers:  $1,550

NOTE: Advance registration is required for this program. Participants are encouraged to register early.

» Registration Online
» Registration Form (PDF) - for registration by mail or fax

Registration Deadline: Advance registration (online, mail and fax) will be accepted until 22 December 2016.

Refund Deadline: 13 January 2017

Proof of Attendance


For those of wishing to have confirmation of course completion, a choice to receive a certificate of completion or a letter of completion will be provided upon request. No RAC or CE credits will be awarded for this course.

Program Contact

John Brown
jbrown@raps.org
+1 301 770 2920, Ext 215

Cancellation

RAPS is not able to accept cancellations by phone. All requests for cancellation must be received in writing. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified.

Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email, to raps@raps.org.

Substitutions may be accepted with written approval from RAPS before 20 January.

NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds for the course. Refunds will be made solely at the discretion of RAPS.