Wearable Injectors and Connected Devices Conference will provide key regulatory updates
SMi Group reports: Gain insights into developments in wearable devices in clinical trials and adapting to decentralised trials during the pandemic
Wearable Injectors and Connected Devices Conference will provide key regulatory updates including guidance on MDR requirements and the impact of Brexit on data collection will be presented by regulatory experts for a comprehensive outlook of this exciting and ever-growing field, and the importance of considering human factors in order to enhance the user experience will be presented by industry experts.
You can view the two-day agenda and speaker programme on the event website:
www.wearable-injectors.co.uk/pjpr3
A Regulatory Outlook including key sessions on:
Impact of Medical Device Regulation on Drug Device Combination Products
- Introduction of MDR requirements
- Impact of MDR requirements on Drug Device Combinations
- Complexity in regulating connected devices
Julia Frese, Director, Medical & Health Services, TÜV SÜD
A regulatory outlook for wearable connected devices
- The use of digital technologies – how are they used in industry and in decision-making
- An overview of the current regulatory framework
- Currently existing recommendations
- Data generation and future considerations
Solange Corriol-Rohou, Senior Director Regulatory Affairs and Policy, Europe, AstraZeneca
MDR Implementation for On-Body Injectors
- Integral drug/device combination products and Article 117
- Non-integral drug/device combination products and aspects to be considered for import, distribution, authorised representative, re-packaging & re-labelling
- Considerations for pharma industry when implementing relevant MDR requirements
- How will the MDR impact the future of the drug/device combination products industry
Andreas Brand, Managing Director, Pro3 Management partnering with Congenius
Regulatory Considerations for On-Body Delivery Systems
- Regulatory analysis of on-body delivery systems as complex delivery devices
- FDA expectations for on-body delivery systems
- Regulatory considerations for on-body delivery systems as a combination product
Priti Baker, Manager Regulatory Affairs Combination Products and Devices, Biogen
Registration is live on the website and a saving of £100 is available for bookings made before 31st August 2021. Register online at www.wearable-injectors.co.uk/pjpr3
Proudly sponsored by: Quantex-arc and Avery Dennison Medical
Contact Information:
For media enquiries contact Jinna Sidhu on Tel: +44 (0)20 7827 6088 / Email:
hsidhu@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