Two Professors
Two Mad Professors
He's a rather unpleasant Crawley resident,so you probably have more abuse coming.I had my vasectomy 35 years ago-shame the operation hadn't reached Crawley by then!
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[Politics] Brexit
- Thread starter KingstonSeagull
- Start date
He's a rather unpleasant Crawley resident,so you probably have more abuse coming.I had my vasectomy 35 years ago-shame the operation hadn't reached Crawley by then!
That doesn't make any sense.
Hmmmmm. I can't be bothered with this anymore. I'm out.
Pfft. How do you manage to get so much, so wrong, so much of the time?
pastafarian
Well-known member
Can you answer my question before you chuck in the towel on this subject, if you dont know fine, im not expecting you to be an expert, but i would like to know just in case you have any knowledge on the subject
JC Footy Genius
Bringer of TRUTH
- Jun 9, 2015
- 10,568
I would certainly agree you have some insight and a better understanding of the main issues and difficulties in coming to a new post Brexit arrangement in this sector.
Those EU laws and rules are currently our laws and rules with no change likely until we have come to a new agreement, 2019 at the earliest. Possibly even longer depending on a transition period being agreed (to 2021). It would seem to be a sensible, mutually beneficial option for the new agreement having reciprocal arrangements recognising standards. In the unlikely eventuality that the no deal scenario is looking a certain outcome then MHRA would need to be funded and expanded to the appropriate level. Easier said than done in the time frame obviously. On the plus side between 33% and 90% of EMA staff say they wouldn't want to relocate depending on the destination city choice. So a pool of talent with the relevant expertise would probably be available.
You also said you would get back to beorhthelm (#38506) for more sensible discussion.
Two Professors
Two Mad Professors
Don't understand the concept of subtle hints,do you?
Two Professors
Two Mad Professors
Ach so,Herr Doktor Professor Klampenfart.Perhaps you would explain to us,in your expert opinion,why the EMA is superior to the WHO,without waiting for the Krautophile or his echo to return.
Brighton Mod
Its All Too Beautiful
So 16 months ago you were telling everyone how important our borders were and now you want no borders.
I really can't be arsed with this level of stupidity this time of night
Never spoken about borders on here in my life, especially 16 months ago. What would the Irish people say if they actually had any input, its not even in the hands of those they have elected. A hard border would be to the detriment on Eire not ourselves and if tarriffs were imposed it would bring untold hardships to their people. They are being used as a pawn in somehting that has nothing to do with decisions and their Jonny come lately Prime Minister, Varadkar has been clearly told to tow the line by his new puppet masters in Brussels. I genuinely fear for Eire in this process they will be left exposed, in receipt of less money from the EU because of the drop in funds from the UK being paid in, an economy being bullied and harrassed by Brussels for more taxes whilst Luxembourg opens its arms to those business who seek to leave Eire because of the tax implications. Big business, money and banks is about al the EU cares about, its not for us much further down the food chain.
Brighton Mod
Its All Too Beautiful
Thought the correlation of Germany being reliant on Russian energy places them in a conflict of interest situation with regards to EU foreign policy, what ever that may be. In activity over Syria by the EU, headed by Germany, allowing the Russain influence to grow, reticence in placing sanctions on Russian over the downing of the RH17 kiling all civilians on board and the tacitness over the annexation of Crimea are l indications of how manipulated Germany can be by the Russians. Its an extremely concerning situation especially as Germany is so behind with its NATO payments and commitments, are they as wealthy as we're led to believe, their eceonomic growth is nothing special.
Yes. Your post still makes no sense.
Sorry we seem to be going around in circles. I'm afraid I don't really understand your question. I am not aware that EMA has bilateral agreements with non EU bodies. EMA regulates medicine in the UK. It used to follow European guidance as it saved the money doing the due diligence ourslves. After that, we harmonized. Arguably it would be better to harminize, after Brexit, with the US since their laws on drug approvals are more stringent than ours (which is why they never had thalidomide - they required proof it would be better than existing drugs not just equal with), albeit after drugs are approved in th US the way they are prescribed is very different, but that is irrelevant.
As far as data access to disease data bases, this is entirely a matter of negiociation. Any agreements we have via the EU will need to be renegociated. It is a bit like utilities, I used to do phone, gas, leccy and t'internet with one company. When I decided to Fexit (i.e., say '**** you and your blanket arrangements with me') I had to make new deals with different companies one by one.
I'm afraid that if this does not address your question then we will have to accept we are two chaps divided by a common language.
ps why do you have a picture of Danny Baker as your personal wallpaper?
Eh? That is like asking why the Champion's League is superior to the World Cup.
Two Professors
Two Mad Professors
Eh? That is like asking why the Champion's League is superior to the World Cup.
They were spreading a bit of doom and gloom about us having no access to the EMA after Brexit,and basically saying the FDA and WHO were irrelevant to the UK's future.I hope we harmonise with the FDA,if possible,as it seems safer and better organised.
Baldseagull
Well-known member
On the grounds that the gene pool would benefit.
Mental Lental
Well-known member
Trust me, you'll feel better for it.
...Will of the people...?
GT49er
Well-known member
Bar chart from a GCSE maths project? Very colourful.....................
pastafarian
Well-known member
Sorry we seem to be going around in circles. I'm afraid I don't really understand your question. I am not aware that EMA has bilateral agreements with non EU bodies. EMA regulates medicine in the UK. It used to follow European guidance as it saved the money doing the due diligence ourslves. After that, we harmonized. Arguably it would be better to harminize, after Brexit, with the US since their laws on drug approvals are more stringent than ours (which is why they never had thalidomide - they required proof it would be better than existing drugs not just equal with), albeit after drugs are approved in th US the way they are prescribed is very different, but that is irrelevant.
As far as data access to disease data bases, this is entirely a matter of negiociation. Any agreements we have via the EU will need to be renegociated. It is a bit like utilities, I used to do phone, gas, leccy and t'internet with one company. When I decided to Fexit (i.e., say '**** you and your blanket arrangements with me') I had to make new deals with different companies one by one.
I'm afraid that if this does not address your question then we will have to accept we are two chaps divided by a common language.
ps why do you have a picture of Danny Baker as your personal wallpaper?
copy and paste job from the EMA website
Bilateral interactions with non-EU regulators
The European Medicines Agency cooperates with many of the world’s largest regulatory bodies outside the European Union (EU) in areas such as inspections, safety of medicines and exchange of information on issues of mutual concern.
In an increasingly globalised pharmaceutical market and a world in which public health issues go beyond national borders, cooperation among medicine regulators has become key to supervising complex supply chains and avoiding duplication of regulatory work and make best use of resources.
International agreements are the basis for current model of collaboration, allowing not only sharing of information but also sharing of work.
In cooperating with non-EU regulators, EMA focuses on mutual reliance and work-sharing and training and capacity-building in countries with less-developed regulatory systems.
Bilateral interactions with non-EU regulators
The Agency has agreements in place with regulators including:
United States of America
Canada
Japan
Switzerland
Australia
New Zealand
Israel
The Agency supports the European Commission's collaboration on pharmaceuticals with:
China
India
Russia
http://www.ema.europa.eu/ema/index....ral_content_000214.jsp&mid=WC0b01ac058003176d
International agreements
EMA has formalised its working relations with a number of third-country regulators through bilateral confidentiality arrangements.
These arrangements enable the parties to exchange confidential information and provide a framework for regulatory cooperation. Their scope focusses on centrally authorised products, including marketing authorisation applications and referrals for human and veterinary medicines.
Switzerland and the World Health Organization (WHO) signed the most recent confidentiality arrangements with EMA in 2015.
The emphasis is on exchange of information concerning regulatory guidance, legislation and non-public information on products, as well as safety information including adverse reactions, good manufacturing practice (GMP) and good clinical practice (GCP) inspection findings.
The Agency has confidentiality arrangements with:
Australia (Therapeutic Goods Administration )
Canada (Health Canada)
Japan (Ministry of Health, Labour and Welfare and Pharmaceuticals and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) )
Switzerland (Swiss Agency for Therapeutic Products and the Swiss Federal Department of Home Affairs )
United States (Food and Drug Administration )
WHO
Mutual recognition
The EU has signed a number of mutual recognition agreements with third-country authorities concerning the conformity assessment of regulated products, which cover the mutual recognition of GMP compliance for human and veterinary medicines.
These agreements aim to facilitate market access while protecting consumer safety and encourage greater international harmonisation of compliance standards.
The EU has mutual recognition agreements with:
http://www.ema.europa.eu/ema/index....ral_content_001842.jsp&mid=WC0b01ac0580c4d3ff
I don’t pretend to understand what these agreements with non EU countries and regulators mean in the context of data sharing and access to disease databases which is why I posed the question to Herr T as this is his job and he brought up the subject of access to disease databases as something he has an above average insight into.
It could be he only deals with intra EU data sharing and doesn’t know either with regard to non EU data sharing/access according to these agreements as this is not something he has knowledge of, I don’t know though, he hasn’t come back with a reply.
GT49er
Well-known member
Yes, but I bet it doesn't happen in.....cough....Germany......