MEDICAL DEVICES


Globally, there are many countries that


are currently developing infrastructure and regulatory pathways for combination products. Overall, it is the dynamic space that has a positive impact on my role, as we all will be at the forefront of developing novel drug-delivery therapies for unmet medical needs.


“The biggest growth area will be in the development of sophisticated customisable product platforms for pre-filled syringes. ”


What current hot topic will you be addressing in your presentation and what would you say makes it relevant to 2020? Life-cycle management and safety aspects of combination products are the current areas of


discussion. USFDA 21 CFR Part 4, Subpart B – post market safety reporting (PMSR) will become effective on 31 July 2020. Companies within the industry will need to build out the appropriate infrastructure to ensure a complete holistic understanding of safety and usability of the combination product.


How would you like to see the PFS USA market developing in the future and where do you think the biggest areas of growth will be in 2020? The biggest growth area will be in the development of sophisticated customisable product platforms for pre-filled syringes. When you look at the unmet medical needs, more sophisticated delivery systems such as next-generation pre-filled syringes will be needed. ●


Outsourcing in Clinical Trials Handbook | 67


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