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: http://www.pre-filled-syringes.com/pr2pj

SMi’s 11th annual 2018 Pre-Filled Syringes & Injectable Drug Devices Europe conference 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 http://www.pre-filled-syringes.com/pr2pj

Contact Information: 

For media enquiries contact Jinna Sidhu on Tel: +44 (0)20 7827 688 / Email:
hsidhu@smi-online.co.uk
 

Sponsors of Pre-Filled Syringes Europe 2019 include:

Fruh, Harro Hoefliger, Mitsubishi Gas Chemical, Nemera, Nelson labs, Owen mumford, PHC Corporation, Schott, Zeon, Zwick Testing Machines.

For details email director Alia Malick at amalick@smi-online.co.uk 

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

 

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