Podcasts

1. Exploring The Interactions Between Validation, Technology Transfer 1/24/2024

   Listen as Gerardo Gomez delves into the intricate relationship between validation and technology transfer, taking into account the perspectives and standards set by regulators.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. Tackling Performance Requirements In The World Of IVDR 4/5/2023

    In this podcast episode focused on navigating the heightened performance requirements of the IVDR, Keely So provides valuable insights and strategies to effectively tackle these regulatory challenges.