Ontario Chapter Webcast: Statistical Concepts for Regulatory Affairs Professionals

1.0
RAC Credits
Chapter Events Chapter Events
Friday, 18 November 2022 (12:00 PM) - Friday, 18 November 2022 (1:00 PM) Eastern Time (US & Canada)

Statistical concepts are fundamental to many regulatory interactions within your organization or regulatory agencies.  This presentation will tackle a few key statistical concepts and help you better understand what it’s all about and its importance.  You will not need to be an expert in mathematics/statistics or memorize formulae for this presentation. This presentation will not make you a statistician (unless you are already one).

A live Q&A portion with the speaker will follow the presentation.

This event is brought to you by the RAPS Ontario Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.

Learning Objective

Sample topics may include: 

1. Why are clinical trials so extensive? (sample size concepts)
2. How can I be confident that my drug/device will be approvable? (confidence intervals and p-values for study results)
3. What is multiplicity, and why should I be concerned?

Registration Fees & Deadlines

Enterprise Member: Free
RAPS Member: Free
Nonmember: $25

Who Should Attend?

Anyone who wants a better appreciation and understanding of statistical concepts.

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.


RAPS Membership

RAPS membership provides vital information for regulatory professionals and a place for networking and invaluable connections. Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. Find out more about RAPS membership today.


Instructors:

Lorinda Simms

Lorinda Simms
Consultant - Regulatory, Biostatistics & Data Management
Partner Therapeutics

Lorinda Simms is an accredited statistical (P.Stat) and regulatory affairs (RAC-US) professional. With over 24 years of experience in health care research, Lorinda has a deep understanding of biostatistics (16 years), regulatory affairs (6+ years), and the regulatory environment.  Lorinda has been an active team member in several Phase 3 studies including go/no-go decisions for regulatory submissions, global regulatory submissions (including regulatory responses and advisory committees), and reimbursement processes.  

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 to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

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

Questions

Contact the RAPS Support Center:

Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org

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