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Submissions and Approvals

John E. Lincoln-600green

Pharmaceutical Process Validation: Best Practices for Success – Webinar Recording/Transcript

$287.00
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Scott R. Burger and William E. Janssen-500aqua

Gene & Cell Therapy Regulation: Comparability and Other New Developments – Webinar Recording/Transcript

$287.00
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EU-MDR’s Growing Pains

Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does – Webinar Recording/Transcript

$287.00
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Richard-Kingston-and-Diane-McEnroe-600red

Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript

$287.00
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Radhika Rajagopalan, Ph.D. - green 600

CDER’s Priorities for 2022: What You Must Know About New Guidance and Program Plans – Webinar Recording/Transcript

$287.00
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Proving Comparability in Cell and Gene Therapy Development

Proving Comparability in Cell and Gene Therapy Development: Untangling FDA Requirements

$397.00
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David L. Chesney Aqua 500

Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections – Webinar Recording/Transcript

$287.00
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Generic Drug Submissions Under GDUFA III: Preparing for FDA’s New Five-Year Plan

Generic Drug Submissions Under GDUFA III: Preparing for FDA’s New Five-Year Plan

$297.00
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Robert Brooks, PhD - 500blue

Supply Chain Solutions: How the Pharmaceutical Industry Can End In-Bound Issue – Webinar Recording/Transcript

$287.00
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Scott R. Burger and William E. Janssen -red600

Gene & Cell Therapy Regulation: Comparability and Other New Developments – Webinar Recording/Transcript

$287.00
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Lance Shea - green600

Statistics and Data for Regulatory Professionals and Attorneys: Product Performance Evidence Made Easy – Webinar Recording/Transcript

$287.00
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The Biden Webinar

The Biden Administration’s FDA: A Remarkable 2021, What to Expect in 2022 – Webinar Recording/Transcript

$337.00
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