Hi Ric,
I'm not going to be able to make the meeting, but all of my smaller clients are hiring companies to do this for them. I am working on a BLA eCTD now and for this one, I don't have to worry about anything, which is nice, because they have one of their consultants transferring everything that I write (I do the nonclinical sections) into their template. Normally, I would have access to and write everything in the template. I am using eCTD formatting, but I don't have o worry about links! :-)
Enjoy the meeting everyone!
Robin
Robin Guy, MS, DABT, RQAP-GLP
Robin Guy Consulting, LLC
Toxicology and GLP Consulting
847.295.9250
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Robin Guy MS
Toxicology and GLP Consultant
Robin Guy Consulting, LLC
Lake Forest IL
United States
robinguy@robinguy.com------------------------------
Original Message:
Sent: 22-Mar-2017 11:39
From: Richard Newman
Subject: Worried about upcoming regulatory changes? Join us tomorrow to learn how to cope!
Carol,
I would really like to understand how Regulatory folks are dealing with small start up companies and the impending switch next year to INDs needing to be submitted electronically. Most start-ups that I have dealt with put zero dollars against this type of thing and investors are not tuned into the changes. So any discussion along these lines would be of interest.
See folks tonight.
Ric
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Richard Newman PhD
Principal
RND Services, LLC
Deerfield IL
United States
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Original Message:
Sent: 21-Mar-2017 18:04
From: Carol Cooper
Subject: Worried about upcoming regulatory changes? Join us tomorrow to learn how to cope!
Join us tomorrow for the RAPS Chicago Chapter event "Tips for Coping with Change". With all the changes in the regulatory field staring us in the face, there isn't a better time to brush up on your skills! Specific topics to be covered include:
- Principals of change
- Change, adaptation and behaviors
- Leadership in the change cycle
- Methodology and communication
On top of improving your always-valuable soft skills, spend some time networking with your local chapter over dinner, included with your registration.
"Tips for Coping with Change" will be held on the AbbVie campus in North Chicago on Wednesday March 22 from 5:30 - 8:30 pm CDT. Click here for more information.
For those of you already signed up, are there any specific upcoming changes you're hoping to discuss?
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Carol Cooper RAC
Associate Director
CM Cooper & Associates
Libertyville IL
United States
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