Veristat Podcasts
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What's New In Decentralized Clinical Trials
8/2/2023
Listen in as Shaheen Limbada, Executive VP of Innovation and Strategy at Veristat, talks about virtual trial tools and strategies to increase efficiencies and save sponsors time and costs in DCTs.
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Apples To Apples: Playing The Comparability Game In Biotherapeutics Development
2/21/2023
Comparability studies are a significant issue for those working in biotherapeutics development. Consider these factors when playing the comparability game in biotherapeutics development.
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The Influence Of MDR’s Article 117 In The Marketing Of Combination Products
2/21/2023
While improving patient safety measures, learn how MDR’s Article 117 is causing implications for manufacturers, as they must fulfill a significant set of additional requirements.
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Considerations For Developing Rare Disease Treatments
1/17/2023
When developing a new therapy for a rare disease, learn why a thoughtful, strategic approach early in the development process supports a well-designed study and agreement to your approach from regulatory authorities.
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The Importance Of Regulatory Project Management
12/8/2022
Listen as members of Veristat’s regulatory team bring to light the invaluable contributions and responsibilities of the Regulatory Project Manager, known for their problem-solving mindset.
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Regulatory Considerations For Biosimilars Development In The U.S.
12/8/2022
Listen as members of Veristat’s Regulatory team delve into the analytical and clinical science of biosimilars and their regulatory pathway.
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Emergency Use Authorizations
11/11/2022
In this podcast, Kevin Hennegan, Veristat’s Director of North American Regulatory Affairs, takes us through the many nuances key to the success of an Emergency Use Authorization application.
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Marketing Application Best Practices For Publishing
11/11/2022
Hear members of Veristat’s Regulatory team guide listeners through several publishing best practices to consider when planning your marketing application.
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CMC Pitfalls: From Benchtop To IND
11/11/2022
Listen as members of Veristat’s regulatory team outline the fundamentals— and the pitfalls— as you determine your readiness to file an Investigational New Drug (IND) from a manufacturing perspective.
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Orphan Drug Designations And Orphan Subsets
10/21/2022
Listen as members of Veristat’s regulatory team shed light on orphan drug designation classifications and the strategic use of subsets in study design.