29: Exploring the interactions between validation and technology transfer
Synopsis: In this podcast, Gerardo Gomez talks about the interactions between validation and technology transfer, considering the views and expectations of the regulators. As Gerardo explains, technol...
24 Jan 202413min
28: Early access programs: What they are and how to plan for them
Synopsis: Early access programs are designed to allow patients suffering from a life-threatening unmet medical need or disease to be given promising treatments that have not yet received marketing app...
5 Dec 202315min
27: Assessing gaps and achieving compliance with Annex 1
Bio Patrick Nieuwenhuizen Quality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked for several global Pharmace...
28 Nov 202315min
26: Navigating the Process of Technology Transfer
Synopsis: Technology transfer involves two main types: scale-up and transfer to a different site. Scale-up technology transfer involves moving a technology or process from a laboratory or pilot-scale ...
14 Nov 202318min
25: Scaling Patient Safety through Innovation
Bio: Michael Braun-Boghos Michael has been working in medicinal product safety for the last three decades. He spent 13 years at the European PV headquarters of Fujisawa, which later became Astellas, ...
25 Sep 202316min
24: Why Early Phase Modeling is Key to Reimbursement and Patient Access
Market access can be a big hurdle for companies to overcome and might require a different approach to the process of gathering evidence to support reimbursement discussions. Early phase modeling can h...
12 Sep 202311min
23: The Unique and Complex World of Combination Products
Combination products offer unique advantages in terms of delivering improved therapeutic outcomes or enhanced patient convenience. Typically, combination products are understood to be a drug-device or...
31 Aug 202310min
22: Avoiding Pitfalls with your Product Development Strategy
Companies often fall into common traps in early-stage product development. These range from interactions with the regulators to their ability to manufacture their product. Forward planning is crucial,...
2 Aug 202312min
