Three Things You Should Know about Medical Device Regulations in Russia and the Eurasian Union, August 2018

A must read blog if interested in Russia pharma and device development

Medical Device Regulations in Russia and Eurasian Union

Dear Colleagues,

Here is my monthly newsletter with the most important regulatory updates on medical devices in Russia and the Eurasian Union for August 2018.

1. Potential Changes in the Eurasian Medical Device Transition Period for certain group of devices

On 6 August 2018, the Eurasian Commission published a draft regulation (link in Russian) that suggests prolongation of the validity of the medical device registration certificates of Eurasian member states for certain group of devices after the end of the Eurasian transition period.
According to Article 11 of the Agreement on the Uniform Principles and Rules Governing Market Circulation of Medical Devices within the Eurasian Economic Union (signed on 23 December 2014 and enforced on 12 February 2016), registration certificates issued by member states prior to the date of enforcement of the agreement are valid no later than the end of the transition period set as 31…

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I would vote for a Corbyn government

I don’t share all the views of the Corbyn cabinet e.g. on the EU – UK relationship in a political sense but I would still vote for a labour government right now.

We need decent human beings with integrity and vision. Whilst many across all parties possess neither at Westminster, infected by the bacteria of greed of selfish interests; the Corbyn cabinet does show signs of listening and representing the needs of different people, the labour party movement has got a far broader understanding of EU interests and relationships than the other parties.

Corbyn has mentioned dialogue with Russia. The Green party do not have expertise and coherence about developing a sensible strategy for engaging in dialogue with Russia any more than far right parties like the Conservatives do.

A personal example – I talk with different people in the UK about various Russia exhibits, visits, books, articles I have read and upcoming visits too. Green party colleagues (with one exception in Leeds) start the usual ranting about Putin and quoting stuff from the mainstream media.

Labour left colleagues are interested in Russia itself, the history of the areas, the contexts surrounding political movements larger and smaller – and the conversation is not just more interesting but it’s a genuine exploration of different views.

I am not a member of the LP but I do think a government could be formed with the Corbyn cabinet that would be more pragmatic than now. And in spite of their Brexit position I think EU colleagues believe that they could work with a Corbyn government too.

Please support EU citizens initiative

Please sign this important petition

PERMANENT EUROPEAN UNION CITIZENSHIP

EU citizens elect the European Parliament and participate in its work, thus exercising treaty rights, enhancing Union democracy, and reinforcing its citizenship. Noting the ECJ’s view of Union citizenship as a ‘fundamental status’ of nationals of Member States, and that Brexit will strip millions of EU citizens of this status and their vote in European elections, requests the Commission propose means to avoid risk of collective loss of EU citizenship and rights, and assure all EU citizens that, once attained, such status is permanent and their rights acquired

Updates – DICATS, Russia, various

DICATS technology – I’m currently investigating transparent LEDs/LCDs.  I wrote about touch many times on previous blog so not again – better people have written and researched in depth. Considering various options for hive site/s. In the UK, for hire for example, there are transparent LEDs – good overview of LEDS & LCDs and a very simple intro to 3D holographic projection . Some suppliers provide film and other options for quickly modifying existing glass for holographic effect projections, dual image and cave projections and switchable glass. We will have a virtual reality 360 camera (Vuze+) available for testing whilst I’m away so we can work out angles and light reflection and whether its feasible.

At Roehampton one of our buildings is being redesigned (including co-design with students) to include a cinema and studios which will be mainly for use of our Media, Culture, Language students but it won’t be ready before the conference so it’s great to see what Drexel’s ACE Lab is up to.

Beyond DICATS…

As it’s the first attempt at this conference we will know by the end of October when submissions are due – whether we have a conference or not (!) And if we do, it has to all go well enough so that it can run in future years too. It doesn’t end there anyway, the art therapist lecturer I am working with specialises in new media and art therapy for research as well as teaching. When I go to Russia , she has asked me to discuss possibilities of working with Russian students/therapists either on a UK / Russian project and/or global project. As well as Tretyakov VR exhibition, hoping to get to Garage whilst I’m in Moscow as they also run art therapy courses there.

I hope to be exploring collaboration options with Roehampton for a future environmental / ecological / conservation project whilst I’m in Siberia. Even more everyone wants to come to Siberia 🙂

Attempting to follow Understanding Russians: Contexts of Intercultural Communication online course via Coursera (free/£), the lecturer is excellent. Although it’s focused at mostly US business audience, there are lots of UK / Russian examples too.

Taekwondo

Still doing patterns but not really much else for now. Have a brick and will once again start in autumn and break it one way or another (perhaps bite into it). Ran the last training session this morning and I got nicely kicked and with power and control so definitely progress. Haven’t made it back to old club but will sort all things membership, insurance in September so that I can advertise properly for the autumn for staff again. I may possibly be involved with looking after any of our young fighters at the Kyorugi Nationals in October.

4 years ago today, I started chanting into the wrong end of a megaphone in Harrogate

Anyone who read my previous blog, please ignore as I blogged the whole march on it.  Like the Darlo Mums – the men are quiet too 😉

Darlington Viking campaigning for the NHS

After months of planning with Leeds Keep Our NHS Public, we had pre-walked routes, liaised with the police, councils and many others. We arrived in Harrogate night of 21st and listened to some amazing speakers in a church in Harrogate.

end of Ripon to Harrogate People's March for NHS leg - sitting in a church eating supper and listening to speakers

The next morning it was my turn – to lead the march from Harrogate to Leeds which was a long stretch – 18+ miles because we had to go through sections of countryside. I think the original Jarrow marchers could probably have walked down the A61 but not in the 21st century due to traffic. We assembled on Harrogate Common also known as The Stray, where people used to graze animals. After being asked a hundred times about whether they could use the toilet before we started, we finally managed to gather everyone in one place and we were ready to move off. I was so busy sorting things and answering questions and talking on phones and walkie talkies that I picked up the megaphone and it wasn’t until Craig told me that I had it the wrong way round that we finally got moving…

Still being asked about toilet stops after about a mile of setting off. socialist worker stall outside the pub in Kirkby OverblowAlso had to keep slowing down as my idea of getting to Leeds on time in the evening and the marching abilities of others did not exactly synchronise. Great views of the Yorkshire dales and even a moor in the distance. Morning break as we arrived in small village – Kirkby Overblow – which Leeds KONP had decorated with bunting and banners. One of the residents said it was the most exciting thing to happen to the village since the coronation !

When I had pre-walked some of the fields I was advised that there might be a bull in one of the fields. But not a bull in sight. We could see a group of bullocks in the field next to us and carried on…to where the fence ended and we were suddenly in the bullock field with them and our stile on the other side of the field. Most of us made it over the fence in time but a few got a bit close and personal – although it was all curiosity, playfulness and friendliness from the bullocks and some mild panic from a few marchers.

bullocks kettling NHS marchers in a field

As one of the marchers put it – didn’t expect to be kettled by bullocks! This is when it hits home that there’s so much going on beside tiring marches to raise awareness and encourage others to add their voices in support of reinstating the NHS. Some people hadn’t walked in the countryside for years, scared of larger animals but were up for doing it again. We had a similar experience later on when walking through a pitch black old railway tunnel, en route to Northampton I think. We held the hands of people who were scared of the dark and got them involved with lots of chanting and whistling. Everyone came through in one piece all the better for it hopefully.

But onwards and next an artistic surprise for the marchers. There’s a sculptor who works in a barn in one of the fields. I had met him on a previous test walk and mentioned that I might be walking past with lots of marchers soon. And fortunately for us he was there and we had a pitstop which was a nice change for the marchers who had started from Jarrow.

We had to change the next bit of routes due to lost time – so no diverting to the Emmerdale set at lunchtime. Still being asked about toilets.

The march section from Leeds outer ring road into the centre of Leeds is about 6 / 7 miles and at this point a few people starting to tire but we had fantastic support from Leeds residents all the way in. It took forever but we finally made it into Leeds about 2 hours later than planned and roared into Victoria gardens by the Town Hall. And a bonus from Bradford – one campaigner had brought flapjack for all of us. Yorkshire friendliness throughout every step !

marching into HeadingleyBardford campaigner with flapjack ! Dr Jacky Davis speaking at the Leeds evening rally

DICATS REVOLive – Digital International Creative Arts Therapies Symposium – February 2019

We are working with a great team at Drexel in the US and others will be handling the core management of the mixed reality 360 streaming including networked social media, virtual reality and other interactive technologies throughout the 24 hours of the symposium. The conference will not be hosted via the website, still in draft but mostly available: https://www.dicats.org

Call for proposals – including from non-professionals who have an interest in this area:

English

Russian

We will be passing a virtual baton around the world with each hive site live 360 streaming in mixed reality for 4 hours. We would love other countries would like to host a hive site  and will amend the timings accordingly. Attendees can take part in person, and/or augmented reality, virtual reality, via social media and via the conference online. As this is a creative group of professionals, the streaming will allow for live interactive digital arts making throughout to

  • Share digital/new media innovations and practices that have the potential to impact creative arts therapists and interrelated professions.
  • Showcase and test digital media community building possibilities through pre-recorded, live in-person and VR interactive activities.
  • Generate dialogue between arts therapists and those in adjacent research, educational and creative communities.
  • Generate content from which to develop an evidence-base for therapeutic digital media inclusion and further funding.
  • Generate networks and ideas to develop collaborations for research and reflective practices.
  • Showcase new digital media and arts technologies (technology companies with interest in this area welcome)

I am also exploring possibilities for collaboration with some great Russians or even a possible Russian speaking hive site at the moment. Hoping to visit the VR spaces at the Tretyakov if time permits at the end of August. It’s a lot of technologies at once and we haven’t streamed in 360 or VR before from Roehampton, but why not 🙂

I found this article useful for pointers on mixed realities, also BBC mixed reality R&D

Many NGO workers on the ground don’t speak the local language – new research from Universities of Reading and Portsmouth

Have also informally written about this concept in reference to water sanitation work. This research was conducted in Kyrgyzstan, Malawi and Peru. Full report – English, Russian

Some key problems they found were:

Languages generally have a low priority in development. DFID officials generally assume that NGOs have sufficient language capacity to communicate with aid recipients. But few NGOs have language policies and language needs tend to be underfunded, even though aid workers are keenly aware of the importance of languages in their work. Many NGOs rely on multilingual staff members on the ground to come up with ad hoc solutions. The problem is that staff are not always fluent in the languages and dialects of the communities that they work with, and so interpretations can be sub par. Communities can become confused about the objectives of aid projects, or even misunderstand them entirely.

Many development concepts that are essential to NGO work are not directly translatable into other languages. Examples include accountability, resilience and sustainability. Aid workers often have to invent their own interpretations of these concepts with minimal guidance from management. The interpretations can vary widely, which exacerbates the confusion of the communities about the purpose of aid projects.

These language problems have negative effects on community participation, and the trust that communities have in NGOs. Certain groups, especially those speaking an indigenous language that does not have official status, end up being effectively excluded from participating in project design, and providing feedback on the performance of the NGO. This is an impediment to establishing relationships of mutual respect.1


1.Footitt H, Crack A, Tesseur W (2018) Respecting communities in International Development: languages and cultural understanding, EN version available at: https://www.reading.ac.uk/modern-languages-and-european-studies/Research/mles-listening-zones-of-ngos.aspx

Info and donation site – Portugal wildfires

https://algarvefire.info/

A relative who lives out there said over 180 people lost their homes in the fires so far.

Learning Russian – cycling information (homework)

Last one of these, my tutor away at the moment.

My town is part of the ‘Ride London’ bike race even though it’s outside London.

Мой город в ‘Ride London’ велогонке хотя это не Лондоне.

It goes up Box Hill, into the town centre then back to London.

Велогонка едеть наверх ‘Вox Hill’ холме влиз в центре и потомна лондоне.

I saw some of the riders. It was raining but several people were near the station to cheer the riders.

Я увидел некоторы велосепедисти идёт дождь но люди смотрели и бодрившей около воксал.

One man was using a megaphone. The cyclists were not together – in small groups so you kept hearing him shouting the same thing.

Мужуина кричал с мегафоном. Велосепедисти не вместе – на маленкий групме. Каждий раз он кричал одно и то же.

He worked at the station. One of his colleagues said he sounded like a cow moo’ing.

Он работает в вокзале. Коллега сказал он как корова мычат!

He was great and he got a free coffee in the pub.

Он очень здорово и потом он пил весплатно кофе в пивнаяе.

I saw the Olympic cycle race a few years ago which uses the same route (but they go up Box Hill 8 times).

Я увидел велогонка олимпиский некоторые лет назад. Это тоже самое но ‘Box Hill’ холмом восемь раз.

We saw a group of riders with same colour as British team and everyone cheered very loudly. I think the US team were surprised to get such a big welcome but they were around the corner before we understood and everyone went quiet.

Мы смотрели групма со то же цвети как великобританьски групма. Все кричали очень громкий. Я думаю этот суприз для сша грука слушали вольшой приветствовать. Но групка исчезла за углом раньше мы понимали и все тихий.

The loudest cheer was for the last rider.

Громкие аплодисменты для последнй велосепедист.

There are now many cyclists every weekend but there are more hills for walking.

И сейчас много велосипедисти каждие выходние но есть много холмые для прогулок.