Preparing to Take the RAC Drugs Exam

12.0
RAC Credits
Thursday, 04 March 2021 (9:00 AM) - Friday, 05 March 2021 (2:00 PM) Eastern Time (US & Canada)


Are you planning to take the Spring 2021 Global RAC Drugs Exam?

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 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 2021 RAC Window closes on February 25, 2021. The Spring testing window runs from 22 March to 30 April 2021

Pricing Amounts & Deadlines

5 February – 25 February 2021: Regular $900 Member | $1000 Nonmember

Who Should Attend?

This workshop is recommended for regulatory affairs professional 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.

    Speakers

    LindaBowen

    Linda Bowen

    Linda Bowen, MSc., RAC, FRAPS, has 38 years-experience in the Biopharma Industry, 28 of which were in regulatory affairs, the last 15 focusing on regulatory intelligence, strategy, and policy. She is head of regulatory policy and intelligence at Seagen and for the last 20 years has been an assistant professor in the Temple University RAQA graduate program. She is a past two-term member of the RAPS Board of Directors and former Chair of the NJ/NY RAPS Chapter. She chairs the DIA Regulatory Affairs Community and is founder of the DIA Regulatory Intelligence Working Group. She sat on the planning committee for multiple DIA and RAPS Conferences and was Program Chair for the 2018 and 2019 RAPS Annual Convergence.





    https://www.raps.org/RAPS/media/Events-Training/Headshots/image004.jpg

    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.


    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 at the following the workshop.

    Questions

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