SMi has released an exclusive interview with industry expert Torsten Kneuss, Quality Assurance Manager Combination Products of Bayer, ahead of the upcoming Pre-Filled Syringes and Injectable Drug Devices conference this January.
As Europe’s leading pre-filled syringe conference, the two-day event is an essential diary date for those in the industry.
During the run-up to the 2020 conference, SMi interviewed industry expert and conference speaker Torsten Kneuss, quality assurance manager combination products of Bayer. Here is a snapshot of what was discussed:
What do you see as the greatest challenge for you to overcome personally in the pre-filled syringes field at the moment?
“There is not one big challenge, but the evolving regulatory landscape which partly also impacts the legacy products leads to additional efforts. While there is a lot of unclarity, e.g. related to the Notified Body Opinion, we have to be prepared.”
What current hot topic will you be addressing in your presentation and what would you say makes it relevant to 2019?
“My hot topics are based on two changes which will become relevant now. The first change is the increased oversight by Notified Bodies to Pre-Filled Syringes as these are single integral products for which Article 117 of the European Medical Device Regulation applies. The second change is the upcoming revision of the ISO 14971, the relevant standard for Risk Management for Medical Devices and Combination Products. Both topics impact Pre-filled syringes in development and from a post-market perspective.”
How would you like to see the PFS Europe market developing in the future and where do you think the biggest growth area will be in 2020?
“I think the market will have a growth by around 10% in sales per year over the next 5 years. I don’t see a very specific growth area, as both plastic and glass-based syringes will have similar growth.”
The full version of the interview and event brochure are available to download online at www.pre-filled-syringes.com/PRcom10
Torsten Kneuss will be giving two presentations:
Day 1: “Design control for combination products.”
- Application of Design Controls to Combination Products – A global perspective
- Introduction to Design Controls for Combination Products
- Challenges with Design Controls for Combination Products
Day 2: “Risk management for combination products.”
- Introduction to Risk Management for Combination Products
- Typical pitfalls in the Risk Management for Combination Products
- Upcoming changes with ISO 1497: 2019
Pre-Filled Syringes and Injectable Drug Devices Conference
Main Conference: 15-16 January 2020
Pre-Conference Workshop: 14 January 2020
Location: Copthorne Tara Hotel, London, UK
For all media inquiries contact Jinna Sidhu on Tel: +44 (0)20 7827 6088 / Email: [email protected]
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