Podcasts

1. Navigating The Digital Era And Beyond For Engaging Key Decision Makers In Specialty Pharmacy 1/17/2025

   Tune in as experts discuss how biopharma companies can effectively engage healthcare decision-makers in the evolving digital landscape.

2. An Overview Of Contamination Control Strategy (CCS) 5/22/2024

   Join experts Londa Ritchey and Patrick Nieuwenhuizen as they explore the key role of a contamination control strategy in Annex 1 for ensuring patient safety and continuous manufacturing improvement.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.