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

6.0
RAC Credits
Virtual Programs
Thursday, 07 October 2021 (12:00 PM) - Friday, 08 October 2021 (5:00 PM) Eastern Time (US & Canada)

Developing and commercializing new medicines and medical devices for patients is a rewarding but complex undertaking, particularly in the context of rapidly changing tools, techniques, and global regulatory requirements. Maintaining awareness of these regulatory changes and providing strategic input into product development teams are critical deliverables of modern regulatory intelligence (RI) programs, yet little information is available on how to setup 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.


Learning Objectives

    At the conclusion of the workshop, participants 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 and regulatory changes, screening and triaging relevant news for your organization, and reporting relevant news to internal stakeholders.
  • Setup and manage tools and processes for conducting ad hoc requests for precedent/predicate searches, including clarifying and triaging incoming requests, conducting searches of publicly available information, and reporting findings to the requestor and other stakeholders..

Registration Fee & Deadlines 

16 July 2021 - 17 September 2021: Early Bird $480.00 Member | $540.00 Nonmember

18 September 2021 - 6 October 2021: $540.00 Member | $600.00 Nonmember

Who Should Attend? 

  • Regulatory professionals building or overseeing new RI programs
  • Regulatory professionals in roles where RI activity is an expectation within their wider role

Speaker(s):

Chris Whalley

Chris Whalley has over 20 years of experience in biotechnology & healthcare operations and is presently the Associate Director of Regulatory Policy & Intelligence at Seagen Inc., a biopharmaceutical company focused on oncology therapies. Prior to joining Seattle Genetics, Chris established and led the global healthcare & life sciences regulatory program at Amazon Web Services and built regulatory and quality programs at Fred Hutchinson Cancer Research Center, Amgen, and several pre-commercial biotech companies in the Seattle area. He founded and then sold a publishing company catering to life science organizations and holds a patent on supplying regulatory compliance evidence for cloud service provider environments.


Sylva Krizan

Sylva Krizan has experience in government, academia and industry with a particular focus on biotechnology. She holds PhD and Master’s degrees in Biomedical Engineering from the University of Michigan, and a B. Chemical Engineering & Society from McMaster University. She was a Commissioner’s Fellow at the US Food and Drug Administration focused on regenerative medicine and combination products with a cross-appointment in CBER and CDRH, as well as a medical device reviewer in CDRH. She built and led a regulatory affairs team at a cancer diagnostics company (NanoString Technology – now licensed to Veracyte) and most recently has led global security and compliance for healthcare and life sciences in security assurance at AWS. Her expertise spans medical devices, diagnostics, biopharma, regulatory affairs, clinical development and cloud computing.


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 support@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 support@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 workshop.


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