2022 Regulatory Seminar Exchange Program

Dear Registrant,

Thank you for your interest in attending the 2022 Regulatory Seminar Exchange Program. The spring session held on Tuesday, April 26, 2022, from 12noon to 2pm ET will address medical devices and drugs.

Please note that this workshop will be held both in-person and via Zoom. A Zoom link for remote attendees will be emailed to you after you complete the Remote attendance registration process. A lunch option will be requested if you plan to attend in person.

Should you have any questions or require special accommodations, please email Karen Grabowski at Karen_Grabowski@urmc.rochester.edu

Sincerely,
Program Faculty:

Joan Adamo, PhD, Director, Regulatory Support Services, UR CTSI
Martin Graham, PhD, Chief Executive Officer, Empire Discovery Institute
Carlos Pena, PhD, Chief Regulatory Officer, Chief Quality Officer, Jacobs Institute
Scott Steele, PhD, Director, Regulatory Science Programs, UR CTSI

Sponsored by: University at Buffalo’s Clinical & Translational Science Institute • Jacobs Institute; University of Rochester Medical Center’s Clinical and Translational Science Institute

REGULATORY SEMINAR
EXCHANGE PROGRAM

Overview. The Regulatory Exchange Program is a two-part seminar series that will provide University at Buffalo (UB) and University of Rochester (UR) students, researchers, and clinicians with the opportunity to hear from experts in regulatory science and in the regulatory review process. The program is being organized by the Jacobs Institute (JI), a nonprofit medical device innovation center, UR’s Clinical & Translational Science Institute (UR CTSI) and UB’s Clinical & Translational Science Institute (UB’s CTSI). Seminars will be located in Buffalo at UB’s CTSI and Rochester at UR’s CTSI. The 2021 Fall Session focused on medical devices and the 2022 Spring session will cover medical devices and drugs.

Purpose. To provide details on FDA Regulatory Science, Drug and Medical Device Oversight, and Regulatory Review and Guidance

The spring seminar is in Rochester on

Tuesday, April 26, 2022, 12:00 pm - 2:00 pm ET, School of Nursing, Fiaretti Room 1W-501 (lunch provided)

The Spring 2022 session will include details about FDA initiatives to support drug and biologic development, including case studies as well as Pre-Submission and IDE processes.

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The option to attend in person has closed.

However, you may still choose to attend virtually.

Please select "Virtually (via Zoom)" and we will send you the zoom joining link!

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Virtually (via Zoom)

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As you have chosen to attend the program virtually, we will send the Zoom link to your email after you have completed your registration.

As you have selected to attend in person, please note that lunch and networking will take place at 12:00pm in the Fiaretti Classroom 1W-501. The presentation will begin at 12:15pm.

Will you need a vegetarian lunch box?

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Yes

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2022 Regulatory Seminar Exchange Program

REGULATORY SEMINAREXCHANGE PROGRAM

Registration is required.

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REGULATORY SEMINAR
EXCHANGE PROGRAM