Podcasts
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Early Access Programs: What They Are And How To Plan For Them
12/5/2023
Explore how early access programs are tailored to individual sufferers of rare, ultra-rare, or life-threatening conditions, as well as cohort programs, which target groups of patients afflicted with the same disease.
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Assessing Gaps And Achieving Compliance With Annex 1
11/28/2023
In this podcast episode on Annex 1 compliance and gap assessment, Patrick Nieuwenhuizen shares his insights and expertise gleaned from extensive experience in pharmaceutical regulation and compliance.
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Navigating The Process Of Technology Transfer
11/14/2023
Olena Chervonenko, Associate Director Quality Management and Compliance at PharmaLex, provides deeper insights into technology transfer and essential factors for achieving success.
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Scaling Patient Safety Through Innovation
9/25/2023
In this podcast episode, Michael Braun-Boghos and Cheryl James share their expertise and perspectives on leveraging innovative approaches to enhance patient safety initiatives.
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Why Early Phase Modeling Is Key To Reimbursement And Patient Access
9/12/2023
In this episode, PharmaLex's Annabelle Fosmark explores the significance of early phase modeling and its evolution as a critical element in securing reimbursement and enhancing patient access.
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The Unique And Complex World Of Combination Products
8/31/2023
Learn how these innovative solutions deliver enhanced therapeutic outcomes and patient convenience, and gain insight into the regulatory strategy governing their approval process.
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Avoiding Pitfalls With Your Product Development Strategy
8/2/2023
With over 15 years of experience in global drug development, Alex Klein brings a wealth of expertise to navigating challenges associated with regulatory affairs, business development, and marketing.
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Navigating Regulatory Environments To Bring Products To Market
7/18/2023
Explore the opportunities and challenges presented by globalization in the pharmaceutical sector as explained by Dr. Jürgen Hönig, Senior Director of Regulatory Business Intelligence.
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Safety Reporting Requirements For Marketing In The EU
7/6/2023
Uncover the complexities of managing European pharmacovigilance legislation and the additional challenge of navigating individual requirements set by each EU Member State, which may implement regulations differently at the national level.
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How The Quality Culture Impacts GMP Activity
2/22/2023
Londa Ritchey shares invaluable insights derived from her extensive experience, shedding light on the pivotal role of fostering a strong quality culture in maintaining GMP compliance.