Interview released with West Pharmaceutical Services
SMi Group are delighted to have Dr. Bettine Boltres, Technical Account Manager from West Pharmaceuticals Services, Co-Chair the 10th annual conference and exhibition on Pre-Filled Syringes when it returns to Central London on 17th and 18th January 2018.
Dr. Bettine Boltres is actively involved in regulatory committees such as USP, Ph Eur and ISO. In her current role as Technical Account Manager, she is in close contact with the pharmaceutical industry and has first-hand experience in understanding the challenges it faces.
“To bring the pharmaceutical industry together to discuss these challenges and to exchange with the regulatory bodies is an important part in driving the future of the pharma industry. That is why I support the Pre-Filled Syringes Europe conference.” – Dr. Bettine Boltres
In the run-up to the event, we caught up her to discuss current industry hurdles and the upcoming conference. From the answers provided it is apparent that compliance and new guidelines will be a major area of focus to determine future regulatory pathways for the PFS market.
When asked to comment on the expected updates to USP <660> and USP <381>/<382> and their impact on the industry, she said:
“The chapter <660> dealing with glass primary packaging has not been updated in many years. So the revision will come in two steps: First, some general minor changes as well as alignments with Ph Eur are implemented. In the second step the bigger, more thought-requiring topics are addressed, such as Extractables & Leachables, elemental impurities, light transmission and new glass formulations. The chapter <381> has just undergone such a big revision. It was split into two chapters separating the quality assessment of the components and the closure functionality plus adding the according informational chapters above 1000. In this development you can see the clear trend towards an individual assessment of the primary packaging quality depending on a scientifically sound risk assessment and specific drug product requirements. The regulatory bodies do not want the pharmaceutical companies to just follow the instructions anymore.“
As well as Co-Chairing Pre-Filled Syringes Europe alongside Alphons Fakler, Group Head Risk Management, Biologics Technical Development and Manufacturing , Novartis Pharma AG; Dr Boltres will also be leading an industry-led panel discussion with Novartis, GSK and Merck. The event spotlight on regulation will also include an exclusive opening keynote address from the MHRA.
SMi’s 10th annual 2018 Pre-Filled Syringes Europe conference and exhibition will take place on 17th & 18th Jan at the Copthorne Tara Hotel, Kensington, London UK.
Further information including a detailed agenda and full speaker line-up is available at http://www.pre-filled-syringes.com/
The full interview is available to read at http://www.smi-online.co.uk/goto/2018pfs.asp#tab_downloads
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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