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driving the industry including advancing development for drug delivery devices, regulatory updates including the FDA draft guidance on bridging studies, connectivity and digital health for combination products and compatibility for drug delivery systems.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/phqpr5
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/phqpr5
Sponsored by Almac, BD, Polyplastics-Topas, Weiss-Aug & Zeon
—ENDS—
For all media inquiries contact Jinna Sidhu on Tel: +44 (0)20 7827 6088 / Email: hsidhu@smi-online.co.uk
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk
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