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. Building a content planIncluding vendors in your pro

Planning Your First IND Part 2: FDA Interactions

Mar 5th, 2021 16m 33s

Vanessa Phillips, Head of Operations at WAYS, and Michelle McGuinness, President and Principal at Pharmaceutical Compliance Partners discuss pre-IND interactions with the FDA.How do you prepare for a pre-IND meeting?What's in the Pre-IND p

Planning Your First IND Part 1: Budgeting & Resources

Mar 5th, 2021 18m 22s

Vanessa Phillips, Head of Operations at WAYS and Michelle McGuinness, President and Principal at Pharmaceutical Compliance Partners discuss budget and resourcing considerations. Do you have the internal talent you need? Does your team hav

Data Submissions

Jan 17th, 2021 19m 45s

In this episode, Shannon Heacock, Head of Regulatory Submissions at WAYS Pharmaceutical Services, and Mike Willis, CEO of Tradecraft Clinical Research discuss the planning and production of data submissions.Shannon brings the regulatory perspe

Emergency Use Authorizations During the COVID-19 Pandemic - Part 3

Nov 5th, 2020 29m

In this episode, Dr. Nancy Smerkanich provides an update from the recent Vaccines and Related Biological Products Advisory Committee Meeting. The Advisory Committee Meeting lasted 9 hours and Emergency Use Authorizations continued to be a high

Emergency Use Authorizations During the COVID-19 Pandemic - Part 2

Oct 26th, 2020 22m 46s

In this episode, we continue our conversation with Dr. Nancy Smerkanich, Assistant Professor at the University of Southern California School of Pharmacy. Dr. Smerkanich shares her insights into current Emergency Use Authorizations, how sponsors

Emergency Use Authorizations During the COVID-19 Pandemic

Oct 26th, 2020 20m 1s

In this episode, we talk to Dr. Nancy Smerkanich, Assistant Professor at the University of Southern California School of Pharmacy about Emergency Use Authorizations (EUAs). Nancy describes what EUAs are and how they are being used in the curren

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