Exclusive New Interview Released with Allergan Global Regulatory Affairs Director Ahead of Pre-Filled Syringes San Diego Summit
SMi Reports: Allergan discuss human factors, smart devices and new technologies in the run-up to Pre-Filled Syringes West Coast 2017
San Diego, CA, April 14, 2017 --(PR.com)-- SMi Group have released an interview with John Smith, Director of Global Regulatory Affairs from Allergan, ahead of his keynote address at the upcoming San Diego industry summit on Pre-Filled Syringes this June.
With over 25 years of experience in medical device, pharmaceutical regulatory affairs and quality assurance, John Smith is currently responsible for Allergan’s medical device and combination product regulatory strategies, including aligning drug and drug-delivery system development approaches and guiding development teams on combination product requirements.
His keynote address at Pre-Filled Syringes West Coast 2017 will navigate the global regulatory ecosystem taking into account regulatory requirements for USA, Europe and ROW, to ensure product success in a global market. Highlights will include an update on key points from different regulatory bodies and guidance on what to consider when seeking approval. He will also explore issues surrounding safety assessments and human factors considerations.
In the build-up to his presentation, SMi Group caught up with John to discuss current industry challenges, developments and his upcoming talk. From the answers given, it is apparent patient centricity is a key factor in the success of medical devices.
“Improving the patient’s ability to remember to use the product correctly is more complicated than drug delivery system design. Smart devices, mobile medical apps, and wearable/ingestible sensors show some promise in this area, although much work remains to be done to get these to a performance level where regulators will accept their use.
“… smart devices and connected health technologies have considerable potential to improve patient adherence and the patient experience with medical devices, drug delivery systems and pharmaceuticals. However, these are still in their infancy and many technologies have yet to be proven. Additionally, regulators are quite conservative in this area and are likely to demand high levels of scientific evidence showing that these technologies are appropriate for their intended use before they approve them for use by the general public. Most drug development companies are not experts in this area, so I believe that in the next 5 to 10 years we will see many more partnerships between pharmaceutical and technology companies to develop these technologies.”
The full interview can be read online at http://www.smi-online.co.uk/goto/2017pfs-west-coast.asp#tab_downloads
Further information on Pre-Filled Syringes West Coast 2017 is available at http://www.prefilled-syringes-westcoast.com/pr.com
Pre-Filled Syringes West Coast
June 5th and 6th
Hyatt Regency, San Diego, CA
www.prefilled-syringes-westcoast.com
Contact Information:
For all media inquiries contact Teri Arri on Tel: +44 (0)20 7827 6162 / Email: tarri@smi-online.co.uk
For all other inquiries contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email: amalick@smi-online.co.uk
Pre-Filled Syringes West Coast event sponsors: Mitsubishi Gas Chemical Co, Nemera, Nipro Pharma Packaging, Overlook Industries, Steri-Tek, Terumo Europe, Worrell, Zeon Chemicals
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
With over 25 years of experience in medical device, pharmaceutical regulatory affairs and quality assurance, John Smith is currently responsible for Allergan’s medical device and combination product regulatory strategies, including aligning drug and drug-delivery system development approaches and guiding development teams on combination product requirements.
His keynote address at Pre-Filled Syringes West Coast 2017 will navigate the global regulatory ecosystem taking into account regulatory requirements for USA, Europe and ROW, to ensure product success in a global market. Highlights will include an update on key points from different regulatory bodies and guidance on what to consider when seeking approval. He will also explore issues surrounding safety assessments and human factors considerations.
In the build-up to his presentation, SMi Group caught up with John to discuss current industry challenges, developments and his upcoming talk. From the answers given, it is apparent patient centricity is a key factor in the success of medical devices.
“Improving the patient’s ability to remember to use the product correctly is more complicated than drug delivery system design. Smart devices, mobile medical apps, and wearable/ingestible sensors show some promise in this area, although much work remains to be done to get these to a performance level where regulators will accept their use.
“… smart devices and connected health technologies have considerable potential to improve patient adherence and the patient experience with medical devices, drug delivery systems and pharmaceuticals. However, these are still in their infancy and many technologies have yet to be proven. Additionally, regulators are quite conservative in this area and are likely to demand high levels of scientific evidence showing that these technologies are appropriate for their intended use before they approve them for use by the general public. Most drug development companies are not experts in this area, so I believe that in the next 5 to 10 years we will see many more partnerships between pharmaceutical and technology companies to develop these technologies.”
The full interview can be read online at http://www.smi-online.co.uk/goto/2017pfs-west-coast.asp#tab_downloads
Further information on Pre-Filled Syringes West Coast 2017 is available at http://www.prefilled-syringes-westcoast.com/pr.com
Pre-Filled Syringes West Coast
June 5th and 6th
Hyatt Regency, San Diego, CA
www.prefilled-syringes-westcoast.com
Contact Information:
For all media inquiries contact Teri Arri on Tel: +44 (0)20 7827 6162 / Email: tarri@smi-online.co.uk
For all other inquiries contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email: amalick@smi-online.co.uk
Pre-Filled Syringes West Coast event sponsors: Mitsubishi Gas Chemical Co, Nemera, Nipro Pharma Packaging, Overlook Industries, Steri-Tek, Terumo Europe, Worrell, Zeon Chemicals
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
Contact
SMi Group
Teri Arri
+44 (0) 207 827 6162
http://www.prefilled-syringes-westcoast.com/prcom
Teri Arri
+44 (0) 207 827 6162
http://www.prefilled-syringes-westcoast.com/prcom
Contact
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