Preparing to Take the RAC Drugs Exam

Are you planning to take the RAC-Drugs exam in 2022?

Join others from the regulatory community for a workshop/study group crafted to sharpen your critical, analytical and strategic test-taking skills. The sessions will be facilitated by a panel of certified (RAC) regulatory professionals that are subject matter experts in their field.

During the workshop, faculty will review challenge questions similar to the style and content of the RAC Exam. This style of teaching has been used in other preparatory workshops and has been determined to be most useful for those taking the RAC Exam.

Participation in this workshop should not be your only method of exam preparation. RAPS provides many exam preparation materials which can help you develop a comprehensive study plan.

NOTE: Registration for the Spring 2022 RAC Window closes on February 24, 2022. The Spring testing window runs from 21 March to 29 April 2022.

Pricing Amounts & Deadlines

23 February 2022 – 23 August 2022: Early Bird $825 Member | $970 Nonmember

24 August 2022 – 4 October 2022: Regular $970 Member | $1,150 Nonmember

Learning Objectives

Attendees will learn how to analyze around 200 RAC Drug questions and how to pick answers that look to have two correct answers.

Who Should Attend?

This workshop is recommended for regulatory affairs professionals with:

• A minimum of two to three years of regulatory experience.
• Knowledge of the full product development and lifecycle for pharmaceutical and medicinal and related products, APIs, biologics and biotechnology products.
• Knowledge of US FDA requirements.
• Understanding of European regulations and guidance from the European Commission, EMA, and competent authorities.
• Understanding of globally applicable regulatory practices (ICH, IGDRP (Generics) and WHO guidelines and standards).

Agenda

The two-day program will break down questions from RAC Drugs Practice Exams, focusing first on the US, moving on to EU and ending with Global. The course will be open discussion with questions and the amount of time on the topics will be dictated by the attendees. There will be a study group on RAPS regulatory exchange where you will be able to further discuss questions and study strategies with the presenters and fellow attendees.

The program will run from Tuesday, 4 October 2022 11:00 AM- 4:00 PM ET through Wednesday, 5 October 2022 from 11:00 - 4:00PM EST  11:00 AM- 4:00 PM ET.

Speakers

Tyler Vandivort

Tyler Vandivort, PhD, RAC is a toxicologist by training whose graduate/postdoctoral work as an NIH Training Grant recipient at the University of Washington and Cedars-Sinai Medical Center focused on the role of extracellular matrix proteins in the acute and chronic immune response to sterile and non-sterile injury. During his more than 5 years of contract research organization (CRO) experience, first as an Immunotoxicology Research Scientist at Charles River Laboratories, and then as a consultant in the Regulatory Affairs and Scientific & Strategic Development group at Medpace, Tyler has cultivated an understanding of the key procedural and strategic components of nonclinical and early phase clinical development that drive program success. He received a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) in 2019.

Dr. Darin S. Oppenheimer

Senior Director, US Regulatory Diabetes Group 

Medtronic 

Darin joined Medtronic with 19 years of experience in many facets of the product development lifecycle, including regulatory submissions and due diligence. He has actively participated with industry trade organizations and on standards committees. His time as a research and development scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. 

Darin’s educational background includes an undergraduate degree in Molecular Biology from the University of Tampa, two Masters Degrees from Johns Hopkins University (JHU) in Biotechnology and Regulatory Science, and a graduate Certificate in Biotechnology Enterprise also from JHU. Darin completed his Doctorate degree in Regulatory Science from the University of Southern California in 2016. Darin is also a 2017 Regulatory Affairs Professional Society Fellow. 

Darin has contributed to more than two dozen journal articles in the areas of medical devices, drug discovery, and regulatory affairs. He’s lectured at more than three dozen symposia and participated in panel discussions and poster presentations at industry conferences. 

Sanje Goonasekera, PhD, PharmD, RPh, RAC (US, Drugs)

Associate Director

Regulatory Affairs at Magenta Therapeutics

Dr. Sanje Goonasekera is an Associate Director of Regulatory Affairs at Magenta Therapeutics, a company developing medicines to bring the curative power of immune system reset through stem cell transplant to more patients with blood cancers, genetic diseases and autoimmune diseases. He also serves as an adjunct professor at the James L. Winkle College of Pharmacy at the University of Cincinnati. He has more than 10 years of experience in pre-clinical and clinical research. Prior to Magenta, Dr. Goonasekera was at Medpace, a clinical research organization conducting global clinical research for the development of drugs and medical devices. He holds both the RAC Drugs and RAC US certifications. 

Cancellation Policy

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 via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and the event title. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. 

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance following the workshop.

Questions

Call RAPS Support Center at +1 301.770.2920, Ext 200 or email workshops@raps.org.