Regulatory submission professionals talking about all things regulatory. -What's the latest on electronic regulatory submissions? -What do I need to know about CDISC compliant data packages? -What are most teams doing to support Ad Promo submissions in eCTD format? We'll talk about trends, best practices, and emerging regulations. We'll also interview leaders from across the industry to share perspectives and lessons learned. Join us!
WAYS of WORKING
Claim This Podcastby WAYS Pharmaceutical Services
5.0(1 reviews)
7 episodes
Updated Daily
Accepts GuestsHas Sponsors
Podcast Overview
Regulatory submission professionals talking about all things regulatory. -What's the latest on electronic regulatory submissions? -What do I need to know about CDISC compliant data packages? -What are most teams doing to support Ad Promo submissions in eCTD format? We'll talk about trends, best practices, and emerging regulations. We'll also interview leaders from across the industry to share perspectives and lessons learned. Join us!
Language
🇺🇲
Publishing Since
10/26/2020
1 verified contact email on file for WAYS of WORKING
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Recent Episodes
March 5, 2021
Planning Your First IND Part 3: Submission Planning
<p>Vanessa Phillips, Head of Operations at WAYS, and Michelle McGuinness, President and Principal at Pharmaceutical Compliance Partners discuss the content and format of the IND submission. </p> <ul> <li>Building a content plan</li> <li>Including vendors in your process</li> <li>Getting the whole team on the same page</li> </ul> <p>Vanessa and Michelle share practical tips and important considerations as you embark on your first IND project. </p>
March 5, 2021
Planning Your First IND Part 2: FDA Interactions
<p>Vanessa Phillips, Head of Operations at WAYS, and Michelle McGuinness, President and Principal at Pharmaceutical Compliance Partners discuss pre-IND interactions with the FDA.</p> <ul> <li>How do you prepare for a pre-IND meeting?</li> <li>What's in the Pre-IND package?</li> <li>How do you get the package to the FDA?</li> </ul> <p>Vanessa and Michelle offer strategic insights and operational details that will ensure successful agency interactions leading up to your first IND submission. </p> <p><br></p>
March 5, 2021
Planning Your First IND Part 1: Budgeting & Resources
<p>Vanessa Phillips, Head of Operations at WAYS and Michelle McGuinness, President and Principal at Pharmaceutical Compliance Partners discuss budget and resourcing considerations. </p> <ul> <li>Do you have the internal talent you need? </li> <li>Does your team have the right skill sets?</li> <li>What software do you need to get the job done?</li> </ul> <p>Vanessa and Michelle give you answers to these questions and more!</p>
7 total episodes available
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Frequently asked questions
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- What is WAYS of WORKING?
- How often does this podcast release new episodes?
This podcast updates daily.
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This podcast is available on 4 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.
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Yes, this podcast regularly features guests.
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