World Pharmaceutical Frontiers speaks to Mike Zojaji - product launch manager, Bayer, on how taking a holistic view of your serialisation, anti-counterfeiting and diversion can build a robust supply chain to your patient. We explore how moving beyond compliance to appreciate the greater needs of your supply chain in track and trace of drugs domestically and internationally, and incorporating challenges associated with counterfeiting, theft, diversion, and false returns to manufacturers into serialisation strategy, can lead to easy and compliant serialisation.
Switching from second-day to overnight shipping can generate savings in most pharmaceutical transport processes. We speak to Michael English, associate director of engineering - packaging technical operations at Merck, about this idea and its potential to help companies come in under budget and ahead of time.
- How do you apply an all around data management system that is able to track and trace throughout the whole product supply chain? World Pharmaceutical Frontiers talks to Marcel De Grutter, business technology manager operation, Abbott Laboratories, about how to implement serialisation and traceability across multiple partners and systems.
- We discuss international regulations for UDI to determine your approach for each territory and delve into the regulatory requirements defined by US bodies to ensure compliance with UDI standards. WPF will compare US UDI regulations with those in Europe and globally to determine nuances and efficient strategy, and how looking further afield to determine UDI regulations for emerging regions could make sense to ensure minimal upheaval and maximum compliance when it comes to global distribution.
With an increasing trend towards self-administration and treatment outside of a clinical environment, it is becoming more critical to understand the needs of the patient, and ensure that drug delivery devices are designed and deployed with the patient in mind. We look at ways to improve patient outcomes through consideration of user needs analysis, design for affinity, human factors, training/onboarding and ways to improve patient adherence, and speak to Adalberto Ramirez, vice-president of Quality at Amgen.
- Combination products comprise any combination of a drug and a device but remain subject to the regulatory requirements associated with their constituent parts. Several pharmaceutical companies have successfully launched similar combinations products, with an embedded prefilled syringe, in different regions of the world. We look at these developments and the regulatory strategy that support them with Manfred Maeder, head of device development & commercialization, Novartis.
Chemicals and raw materialsTop
The topic of immunogenicity caused by protein aggregates is a key issue in pharma development. World Pharmaceutical Frontiers explores one aspect; namely, the aggregation caused by silicon oil used as lubricant in syringes and cartridges. Dr John Carpenter, Professor of Pharmaceutical Sciences, School of Pharmacy, University of Colorado, speaks to WPF about in-vitro data and clinical data to show how this field is progressing.
Monitoring and minimising the effect of shock and vibration on pharmaceutical products during transportation is an important way of maintaining a solid and dependable product. World Pharmaceutical Frontiers delves into how to achieve a good supply chain where you can depend on partners and how to go about fixing this often overlooked, but expensive, problem.
How can you work with airlines, airports and suppliers to take advantage of the speed and convenience of airfreight, while remaining compliant with global temperature control requirements? Glyn Hughes, of IATA, speaks to World Pharmaceutical Frontiers about this thorny issue.
Utilising global target labels to improve label development and design, and define global target level to determine needs for the region, is an important step in a product's life. We discuss the benefits of developing a global target level to create appropriate labels worldwide with Roshni Babaria - global labelling compliance and regulatory affairs at Allergan, and highlight how to begin the process and when to start.
WPF looks at striking a balance between what is expected and what the industry/CDMO is willing to support. Tomas Landh, director of Novo Nordisk, discusses how to survive the regulatory Catch-22 of balancing cost reductions with increasing regulatory demands for more measurements and analysis. Which is more important: better medicines vs reduced costs −which do we want more?
Editorial contents are subject to change.