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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
Upon completion, students should be able to:
Click here to download the agenda
Chris Whalley brings 20 years experience in biotechnology & healthcare operations and is currently Sr. Manager of Regulatory Policy & Intelligence at Seattle Genetics, a biopharmaceutical company focused on oncology therapies. Prior to joining Seattle Genetics, Chris established & led the global healthcare & life sciences regulatory program at Amazon Web Services, and he previously built regulatory & quality programs at Fred Hutchinson Cancer Research Center, Amgen, and a number of pre-commercial biotech companies in the Seattle area. Chris also founded and sold a publishing company catering to life science organizations, and he holds a patent on supplying regulatory compliance evidence for cloud service provider environments. When not at work, Chris enjoys spending time with his family and tending to his fruit and vegetable garden.
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: All cancellation requests must be submitted
in writing to firstname.lastname@example.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 email@example.com. RAPS will allow substitutions up
to the first day of the event.
Meeting and Events Specialist
Regulatory Affairs Professionals Society®
Tel: 301 770 2920, ext. 229
5635 Fishers Lane, Suite 400, Rockville,
MD 20852 USA