R&D Advisors, LLC - I am also available to train your exisiting staff; this may be an economical approach for your long-term objectives. Below are examples of my lectures and teaching activity for various professional organizations. Training opportunites are largely remote and utilize various instructional technologies.

R&D Advisors, LLC

Regulatory Affairs Outsourcing Solutions

R&D Advisors, LLC
P.O. BOX 472
Ann Arbor, MI 48105
United States
mitch.seymour@rndadvisors.com

I am also available to train your exisiting staff; this may be an economical approach for your long-term objectives. Below are examples of my lectures and teaching activity for various professional organizations. Training opportunites are largely remote and utilize various instructional technologies.

Recent Training and Teaching Activities

Faculty, eSubmissions University
Instructor for eSubmissions-related training
Faculty, San Diego State University, Regulatory Affairs 696, Electronic Submissions
Train students to compile intial and lifecycle submissions in eCTD using commercial publising software by LORENZ Life Sciences.
Faculty, Regulatory Affairs Professional Society (RAPS) webinar "FDA Hot Topics: Update on Medical Device Guidances"
Teach content on recent changes to eCopy, CDRH Refuse to Accept policy, and IDE Tracking.
Faculty, Regulatory Affairs Professional Society (RAPS) webinar "Electronic Submissions for INDs and IDEs"
Teach content on MS Word best practices for eCTD-compliant PDFs and eCopy
Faculty, Regulatory Affairs Professional Society (RAPS) course "Advanced eCTD"
Instruct on Clinical content of eCTD - Modules 2.5, 2.7, and 5.

Web Hosting by Turbify

R&D Advisors, LLC
P.O. BOX 472
Ann Arbor, MI 48105
United States
mitch.seymour@rndadvisors.com

Faculty, eSubmissions University

Faculty, San Diego State University, Regulatory Affairs 696, Electronic Submissions

Faculty, Regulatory Affairs Professional Society (RAPS)﻿ webinar "FDA Hot Topics: Update on Medical Device Guidances"

Faculty, Regulatory Affairs Professional Society (RAPS) webinar "Electronic Submissions for INDs and IDEs"﻿

Faculty, Regulatory Affairs Professional Society (RAPS)﻿ course "Advanced eCTD"

Faculty, Regulatory Affairs Professional Society (RAPS) webinar "FDA Hot Topics: Update on Medical Device Guidances"

Faculty, Regulatory Affairs Professional Society (RAPS) webinar "Electronic Submissions for INDs and IDEs"

Faculty, Regulatory Affairs Professional Society (RAPS) course "Advanced eCTD"