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.
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..
Pricing Amounts & Deadlines
16 July 2021 - 17 September 2021: Early Bird $480.00 Member | $540.00 Nonmember
18 September 2021 - 6 October 2021: Early Bird $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
Associate Director, Regulatory Policy and Intelligence, Seagen Inc
Sylva Krizan, PhD
Regulatory Affairs, Amazon
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 firstname.lastname@example.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 email@example.com with the event title, name of the original registrant and the contact information for the new attendee.
RAPS will send an electronic letter
or a certificate of attendance at the following the workshop.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email firstname.lastname@example.org