Regulatory Round up - Plus new Q&A from our latest webinar on VaiNet Technology
This week we offer several items for your blog-reading pleasure:
- A link to our recent VaiNet Wireless monitoring webinar, recording, and slides
- Q&A from that webinar and we will continue to publish the answers to your questions as they continue to come in by email. Thank you for all this wonderful engagement!
- Links to upcoming regulatory changes from the FDA, EMA, Health Canada, China, and Japan...
- A link to a new webinar on CO2 measurement
First, the recorded version of our VaiNet Wireless Monitoring webinar is available. You can access the VaiNet recorded webinar and slides.
Part 1 of our Q&A from the VaiNet webinar
Can the data points be fed up to a larger system via BACnet?
The data points cannot be fed directly to BACnet. To import the data into a BACnet system, you would need to query the viewLinc database. This is not a usual feature, but we could work with you to develop it for your application. Contact our applications engineers.
How does VaiNet compare with fiber?
If I understand your question correctly, you are asking to compare the wireless VaiNet system against a fiber optic cable system. The two are quite different. Fiber optic cable is a fixed physical connection that has a lot more in common with Ethernet cabling.
VaiNet is a wireless solution that requires minimal infrastructure and offers flexibility and easy install. If comparing data rates, fiber optic cable will have a much higher data rate, as VaiNet by design only handles the small packets associated with encrypted monitoring data.
How big are the VaiNet transmitters?
The RFL100 data loggers are compact - about twice the size of a pack of cigarettes.
How much time between sensor measurement reporting?
Such as in minutes, seconds or milliseconds...The sensors will take measurements every minute. The sensors will transmit their measurements to the viewLinc Server, via the AP-10, every 4 minutes. The average time between the time of the measurement and its appearance in the database is about 2 minutes.
The AP10 can be used outdoor on tropical environments?
The AP10 Access Point is designed for indoor use.
When will the VaiNet RFL, AP10, viewLinc 5.0 become available for purchase and implementation?
The release is planned for late 2017.
Can we do an on-site study to see if we can replace WiFi routers?
Sure. Let’s get together and install some devices at your site. Best to connect with one of our engineers.
Do data loggers imply also sensors/transducers?
Yes. The sensors are housed in a probe installed in the RFL-Series Data Loggers.
Global Regulatory Round-up: Anticipated Changes for 2017
First - the MHRA has published new Orange and Green guides, available at Gov.UK
And the EMA is implementing new Clinical Trials Regulation. - See more at European Commission Web site.
Recently in March, the EMA and the FDA announced they would initiate the new Mutual Reliance Initiative - where both regions will recognize each other's GMP inspections of pharmaceutical manufacturing facilities. The hope is that this cooperation between regulators will reduce duplicated inspections, helping reduce inspection costs, allowing both regulators to allocate more resources to areas underserved by their inspectorates.
- Also from the FDA, both the CDER and CBER have published their plans for guidance updates for 2017: CBER and CDER
- For China, CFDA Offers Technical Guidance on Clinical Trials (24 January 2017) - See more at RAPs.org
- In Japan, the PMDA is joining an initiative to share information on GMP inspections The Programme to rationalize international GMP inspections of active pharmaceutical ingredients/active substances manufacturers: EMA document Library
- And late breaking news from Health Canada, it was announced that they will allow eCTD-only for Drug Applications by January 2018 - See more at Health Canada's Website
As always - don't hesitate to contact us by email!