Amgen, MHRA, F.Hoffman-La Roche to present on human factors engineering at Pre-Filled Syringes 2016

SMi Reports (2015.10.21, London): Pre-Filled Syringes 2016: The A-Z Guide to develop a safe, patient-centric and commercially viable drug delivery device.

Online PR News – 21-October-2015 – London – With the demand for biologics drugs continuing to grow, the global pre-filled syringe market is presenting lucrative opportunities for both pharma and device manufacturers. Regulations and safety remain top priorities among pharma and device manufacturers. Regulators are demanding more evidence and data to demonstrate extractable and leachable, as well as a more patient-centric delivery technology (human factor engineering).

SMi’s 8th annual Pre-Filled Syringes Conference and Exhibition, taking place in London, UK, on the 27th and 28th of January 2016, will address human factor engineering through a series of exclusive case-study based presentations delivered by leading experts from MHRA, Amgen, F.Hoffman-La Roche and Medical Device Usability.

Dominique Lavergnat, Senior Device Development Engineer from F.Hoffmann-La Roche Ltd. will review usability challenges of PFS and how human factor study can support the setting of specification and selection of a Rigid Needle Shield (RNS) Design.

Amgen’s Senior Manager, Human Factor Engineering, Valerie Fenster will present a case-study on “Assessing how to reduce risks by design instead of introducing controls”. Valerie will review the challenging concepts in terms of human factor studies and what training should be undertaken to ensure risk management regarding human factors e.g. needle stick injuries.

Vikas Jaitey, Deputy Manager & Pharmaceutical Assessor, Licensing Division, MHRA, will hold an interactive session “Human Factors Engineering Q&A for the Regulator”, where delegates can ask questions to gain a better understanding of regulators' expectations and requirement.
Richard Featherstone, Managing Director of Medical Device Usability Ltd, will speak on “Human Factors (HF) Testing of Pre-Filled Syringes”, discussing what regulators want from HF data and HF validation studies.

Event speakers 2016 include top decision makers from GSK R&D, Sanofi R&D, Novartis Pharma AG, Barts Health Pharmaceuticals, Allergan and many more. A full agenda breakdown and further information on the extensive number of presentations that will take place at PFS 2016 can be accessed at

This global event gathers attendees from leading PFS markets, including Austria, Belgium, Finland, France, Germany, Japan, Switzerland, UK and USA.

As well as an exclusive line up of speakers and presentations, the 2016 event programme also offers two interactive half-day pre-conference workshops where delegates can enhance their knowledge of the PFS market even further. The two workshops offered are: “Pre-Filled Syringes: Development, Packaging and Regulatory Considerations” (led by Horst Koller, CEO, KH Packaging Consulting GmbH) and “Bridging the Gap - From Formulation to PFS Device Engineering” (led by Jean-Rene Authelin, Global Head, Pharmaceutical Engineering, Sanofi R&D).

Pre-Filled Syringes 2016 is proudly sponsored by BD, Medical Device Usability, Mitsubishi Gas Chemical, Nemera, Nipro, Noxilizer, Owen Mumford, Steris, West Pharmaceutical Services. Limited sponsorship opportunities available. For further information contact Alia Malick, Director, SMi, on +44 (0) 207 827 6168 or e-mail

Delegate enquiries: Contact Fateja Begum on +44 (0) 207 827 6184 or e-mail

8th annual Pre-Filled Syringes Conference
27th - 28th January 2016
London, UK
Contact e-mail:
Contact number: Fateja Begum: +44 (0) 20 7827 6184

Contact Information
Julia Rotar
+44 (0) 20 7827 6184