Regulatory Issues for PF Syringes & Injectable Drug Devices

More so than ever injectable drugs are administered using devices like pre-filled syringes, auto-injectors, and pen-injectors. Patient-centricity is driving the future of the injectable drug delivery market whether it’s through more self-administration, connectivity, or even wearable devices. Yet with so many developments and innovations, regulation remains at the forefront of the industry and all those involved must comply.

In January at the Pre-Filled Syringes & Injectable Drug Devices Europe Conference, industry experts will convene in London to discuss these issues, including:

Regulatory Expectations on Emerging Technologies

  • Updates on combination product regulation and the view of auto-injectors
  • The difference between injectors and pre-filled syringes – the line between a drug product and a device
  • Where new technologies fall within the regulatory scope of device development

Speaker: Suraj Ramachandran, Director from MSD

Regulatory Updates in the Pre-Filled Syringes and Injectable Drug Devices Market

  • Safety legislation and revisions to current guidelines
  • Change in device regulations and what that means for the pharmaceutical side of the industry
  • The added layer of safety assurance through physical, preadministrative checks

Speaker: Vikas Jaitely, Senior Manager Pharmaceutical Sciences & CMC Regulatory Intelligence, Merck Group

Harnessing the Digital Exhaust: Incorporating Wellness into the Pharma Model

  • The industry is undergoing a pivotal transformation as traditional drugs are supplanted by next generation product systems
  • Entry point for non-traditional competitors and start-ups to access this market and potentially re-define the value model associated with drug pricing
  • A dynamic patient interface which leads to extraordinary patient engagement

Speaker: Justin Wright, Global Head of Innovation, Novartis

View the full programme here:

SMi’s 11th annual 2018 Pre-Filled Syringes & Injectable Drug Devices Europeconference and exhibition will take place on 16th & 17th January 2019 at the Copthorne Tara Hotel, Kensington, London UK.

Further information including a detailed agenda and full speaker line-up is available at

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