Exclusive interview released with conference chair Susan Neadle, Amgen ahead of Pre-Filled Syringes East Coast 2021
SMi Reports: SMi Group is proud to introduce some insightful content from our chair and expert speaker of the Pre-filled Syringes East Coast virtual conference 2021
The upcoming conference will cover key topics driving the industry including advancing development for drug delivery devices, regulatory updates including the FDA draft guidance on bridging studies, connectivity and digital health for combination products and compatibility for drug delivery systems.
Our conference chair and expert speaker of the Pre-filled Syringes East Coast virtual conference 2021 – Susan Neadle, Executive Director, Combination Products & Medical Devices Regulatory Affairs, Amgen
You can download the full interview, as well as other free exclusive content – post conference report, the latest conference agenda, and list of speakers: www.pfsamericas.com/pjpr5
Here is a snapshot of what was discussed – the full version of the interview is available on the Download Centre.
The Pre-Filled Syringes market has matured greatly over recent years, what key differences have you noticed in the last year regarding significant developments?
“In light of the pandemic, there is increased prevalence of self-administration parenteral devices, particularly as people look for the ease and convenience of treatments in their own homes, rather than in treatment facilities. Couple this with the fact that biological drugs are increasingly being used to target diseases that have historically had no or very limited treatment options available. The rise in biologics for the treatment of chronic diseases has led drug and packaging manufacturers to seek more sophisticated container closures and drug-delivery systems. Pre-filled syringes and other technologically advanced delivery methods for self-injection of drugs are playing a pivotal role in supporting this growing need.”
What do you see as the greatest challenge for you to overcome personally in the pre-filled syringes field at the moment?
“The dynamic global regulatory environment with respect to combination products is a challenge. Professionals in this space need to be adept at staying on top of the evolving regulatory expectations and differing interpretations, from pre-market through post-market lifecycle management in the combination products space.”
What current topic will you be addressing in your presentation and what would you say makes it relevant to 2020?
“I’ll be presenting on Combination Products Risk Management. The key to ensuring quality, safety, efficacy, reliability and usability across the lifecycle of a combination product is effective risk management. The combination products risk management framework and process applied are critical to identify and address the gamut of considerations for development, supplier quality, through post market safety and change management, for each constituent part and the combination product system as a whole. AAMI (Association for the Advancement of Medical Instrumentation) published TIR 105:2020 late last year, and it is a helpful foundation to apply in the absence of other guidance and standards. An effective strategy for risk management will support the effectiveness and efficiency with which combination products are developed, reviewed, marketed and regulated.”
Virtual conference: Online access only $399 applies to pharmaceutical and biotechnology companies only www.pfsamericas.com/pjpr5
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