에피소드 7개

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 WAYS Pharmaceutical Services

    • 비즈니스

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!

    Planning Your First IND Part 3: Submission Planning

    Planning Your First IND Part 3: Submission Planning

    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 plan
    Including vendors in your process
    Getting the whole team on the same page

    Vanessa and Michelle share practical tips and important considerations as you embark on your first IND project. 

    • 16분
    Planning Your First IND Part 2: FDA Interactions

    Planning Your First IND Part 2: FDA Interactions

    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 package?
    How do you get the package to the FDA?

    Vanessa and Michelle offer strategic insights and operational details that will ensure successful agency interactions leading up to your first IND submission. 

    • 16분
    Planning Your First IND Part 1: Budgeting & Resources

    Planning Your First IND Part 1: Budgeting & Resources

    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 have the right skill sets?
    What software do you need to get the job done?

    Vanessa and Michelle give you answers to these questions and more!

    • 18분
    Data Submissions

    Data Submissions

    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 perspective to the conversation while Mike looks at it from the data, programming, and stats view. They cover topics like the most common challenges, risks of noncompliance, and the important role of the Study Data Standardization Plan.

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

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

    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 priority topic throughout the discussion. 

    • 29분
    Emergency Use Authorizations During the COVID-19 Pandemic - Part 2

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

    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 and the agency are interacting, and the expected pressures of developing, producing and distributing products during the pandemic. (Part 2)

    • 22분

인기 비즈니스 팟캐스트

슈카월드
슈카친구들
손에 잡히는 경제
MBC
삼프로TV (경제의신과함께)
이브로드캐스팅
직장인의 책읽기, 직책
keenestbooktalk
월급쟁이부자들 [직장인 재테크 학교]
월급쟁이부자들,월부,월부닷컴
출근길 마케팅 트렌드
곽팀장