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Bootstrapping Your Regulatory Intelligence: Start and Grow a Successful RI Program From Scratch

6.0
RAC Credits
Thursday, 17 September 2020 (9:00 AM) - Friday, 18 September 2020 (2:00 PM) Eastern Time (US & Canada)

The pace of innovation and change in medicinal product development is increasing as are changes in regulatory frameworks and standards. Maintaining awareness of these regulatory changes and providing strategic input to product development teams are critical deliverables of modern regulatory intelligence (RI) programs, yet little information is available on how to set up the processes and tools for a new RI program.

Whether you are a dedicated RI program manager or perform RI activities as part of another role, this hands-on workshop will provide students with the opportunity to leverage the tools and practice the techniques needed to start an RI program from scratch using simple processes and freely available tools and databases, such as Google search, Feedly, Excel, Outlook, ClinicalTrials.gov, Drugs@FDA and others.


Pricing Amounts & Deadlines 

6/23/2020 – 8/14/2020:  Early Bird $400.00 Member | $500.00 Nonmember

8/15/2020 – 9/16/2020:    Regular $500.00 Member  | $600.00 Nonmember


Objectives

Upon completion, students should be able to:

  • Describe the parts of a modern RI program needed for a biopharmaceutical or medical device organization.
  • Setup and manage tools and processes for surveilling the external regulatory environment including: monitoring external news & regulatory changes, screening & triaging relevant news for your organization, and reporting relevant news to your internal stakeholders.
  • Setup and manage tools and process for conducting ad hoc requests for precedent searches including: clarifying & triaging incoming requests, conducting searches of publicly available information, and reporting findings to the requestor and other stakeholders.


Click here to download the agenda


Speakers


RAPS Online Workshop Experience

Join from anywhere to advance your continuing education goals and earn RAC credits. Secure and high-quality live online classroom experience. Interactive tools to foster collaboration. Peer-to-peer engagement and support from instructors.

Cancellation Policy: All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. RAPS will allow substitutions up to the first day of the event.


Program Contact

Stephany Evans
Meeting and Events Specialist
Regulatory Affairs Professionals Society® 
Tel: 301 770 2920, ext. 229
5635 Fishers Lane, Suite 400, Rockville, MD 20852 USA

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