London, United Kingdom, November 23, 2020 --(PR.com
)-- SMi Group is holding the 13th annual Pre-filled Syringes and Injectable Drug Devices virtual conference, taking place on the 13th and 14th January 20211, have confirmed Julia Frese, Department Manager Centre of Combination Products, TÜV SÜD as the round table leader and will be discussing “A regulatory perspective on lifecycle management for injectable devices requires a notified body opinion.”
Secure your attendance today! Pharma and Biotech companies can attend for free, register your place here: www.pre-filled-syringes.com/prcom6
On the run up to the conference, Julia Frese, TÜV SÜD is interviewed by SMi Group to discuss her thoughts on the biggest growth area of the pre-filled syringes market.
Snapshot of Julia 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?
“The biggest impact on combined medicinal products and as such on pre-filled syringes are introduced by the EU medical device regulation as it is amending the medicinal product directive by introducing article 117. Marketing authorization applicant are required to involve notified bodies to confirm the device constituent of the combination to applicable general safety and performance requirements. This does apply to the medical device regulation particularly in terms of general safety and performance requirements. The so-called self-declaration by the marketing authorization applicants will become obsolete from May 2021.”
What current hot topic will you be addressing in your session and what would you say makes it relevant to 2021?
“I will focus more on the lessons learned and on the experience we as a notified body have gained over the last year. Some manufacturers have already obtained notified body opinions, and this is where I would report on. Additionally, as a Team-NB chair member we are working on several guidance documents so I would give an update on the status of those guidance documents. Maybe in this time we may have more clarification from the EMA stakeholder meeting between industry partners, notified bodies, competent authorities and European Medicines Agency.”
The brochure with the full interview, agenda and speaker line-up is available online: www.pre-filled-syringes.com/prcom6
Proudly sponsored by BD Medical, Nemera, Owen Mumford & Zeon
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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