Speaker interview with Krystin Meidell from Biogen ahead of Pre-filled Syringes East Coast 2020
In light of COVID-19, SMi Group’s 7th annual Pre-filled Syringes East Coast has been rescheduled to 26th – 27th October 2020 in Boston. The event is guaranteed to bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry and more.
For interested parties, more information is available online. Registration is also open at: http://www.pfsamericas.com/pharmipr9
Krystin Meidell works with the Regulatory CMC Medical Devices and Combination Products group at Biogen where she has supported combination product regulatory strategy for the past two years, including digital health. Prior to joining Biogen, Krystin’s experience includes global regulatory and analytical roles in active medical devices and software, drug delivery, and diagnostics. She holds a Bachelor of Science degree in Chemical Engineering from Carnegie Mellon University.
Ahead of the conference, SMi Group has caught up with Krystin to examine her views and expectations for the upcoming conference. She discusses topics such the overview of recent changes in regulation and guidance.
Excerpt of Krystin’s Interview:
The Pre-Filled Syringes market has matured greatly over recent years, what key differences have you noticed in the last year regarding significant developments?
“From a regulatory perspective, the most significant updates have been in Europe and our understanding of the impact of Article 117 on medicinal products with integral medical devices”.
What do you see as the greatest challenge for you to overcome personally in the pre-filled syringes field at the moment?
“Uncertainty in the regulatory space. A new regulatory paradigm is taking effect in May 2020 in Europe for pre-filled syringes, and simultaneously there are many questions in the US and globally surrounding digital health and how it will integrate with PFS presentations and what the regulatory implications of those are”.
The brochure with the full interview, agenda and speaker line up is available online at http://www.pfsamericas.com/pharmipr9
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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