Exclusive interview with Julia Frese, TÜV SÜD released ahead of Pre-filled Syringes Europe
SMi Reports: SMi Group are delighted to announce that Julia Frese, Department Manager Centre of Combination Products, TÜV SÜD will be a speaker at the Pre-filled Syringes Europe Conference
By: SMi Group
Secure your attendance today! Pharma and Biotech companies can attend for free, register your place here: www.pre-filled-
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:
Proudly sponsored by BD Medical, Nemera, Owen Mumford & Zeon
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