Sentences with phrase «ema dulakova»

A physician by background, Sophie Olivier has extensive clinical development experience in large and small pharma organizations and has overseen multiple regulatory interactions with both the FDA and the EMA, particularly in regard to pediatric regulation.

Many of these products are reaching late - phase trials with the potential to receive final approval and marketing authorization from regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

GMP Analytical Services Unit certified by the INFARMED (the Portuguese medicines authority, EMA Portuguese branch) and by DGAV (the Portuguese veterinary authority) for quality control and batch release of human and veterinary pharmaceuticals, biopharmaceuticals as well as experimental new drugs.

LYS - GM101 was recently granted Orphan Drug Designation by both the FDA and EMA as well as Rare Pediatric Disease Designation by the FDA.

The process they have followed in order to gather the specific information was to extract from the published literature all pharmacogenomic biomarkers that relate to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved drugs with pharmacogenomic information in their label and make them available in a database that triangulates between drugs, genes and pharmacogenomics biomarkers.

Our definition is similar to the European Medicines Agency (EMA) definition of Advanced Therapy Medicinal Product (ATMP): «Medicinal product for human use that is a gene therapy medicinal product, a somatic cell therapy medicinal product or tissue engineered product» (EMA ATMP Reg.

iBET's infrastructure comprises 16 laboratories fully equipped with state - of - the - art technology (70 m2 each), including a BSL2 laboratory for working with viruses; a GMP Analytical Services Unit certified by the INFARMED (the Portuguese medicines authority, EMA Portuguese branch) and by DGAV (the Portuguese veterinary authority) for quality control and batch release of human and veterinary pharmaceuticals, biopharmaceuticals as well as experimental new drugs; a GMP Mass - Spectroscopy Unit that provides state - of - the - art MS services to the scientific community and Industry; a 2600 m2 bio-pilot plant supporting production and purification of proteins ATMPs and vaccines from bench top to 300 L scale and privileged access to GeniBET Biopharmaceuticals, an iBET spin - off producing ATMPs under cGMP certification for phase I / II / III clinical trials.

Application for approval of this program has also been filed with the EMA.

Barcelona, Spain, officials feel they deserve to host EMA because the city narrowly lost out when London was selected.

An EMA spokesperson says the agency has made a list of things the new location should have.

The United Kingdom hasn't even triggered the negotiations to end its membership of the European Union, but already half a dozen countries are jockeying to host the European Medicines Agency (EMA), currently located in London.

The Dutch government says its central location and excellent connections at Amsterdam's Schiphol airport make it an ideal hub; it also suggests that the Netherlands deserves EMA as «compensation» because the country's economy will be harder hit by Brexit than most.

The decision on where to move EMA will be made by the European Council, comprised of the leaders of the remaining 27 member states, after what is expected to be extensive political negotiations.

Spain's Deputy Prime Minister Soraya Sáenz de Santamaría said the same month that the Spanish government would «fight for Barcelona as the seat of EMA.»

Set up in 1995, EMA employs about 900 people, making it one of the biggest EU agencies; it has a $ 300 million annual budget and draws some 65,000 visitors to more than 500 international meetings every year.

«But assuming the world intends to do something this stupid, then you have to move the EMA.»

German pharmaceutical associations say Bonn is perfect because it's already the home of the Federal Institute of Drugs and Medical Devices, which is larger than EMA.

Protocol assistance will therefore be provided by the EMA to Dr Sylvain Briault at the Centre Hospitalier Régional in Orléans (west - central France) and his team at the Immunologie et Neurogénétique Expérimentales et Moléculaires laboratory — INEM (CNRS / University of Orléans) during the clinical development of the molecule.

The European Medicines Agency (EMA) has granted «orphan designation» to BMS 204352 (1), a molecule developed by the CNRS to treat Fragile X Syndrome, a rare genetic disease for which there exists no treatment.

«We have done over 50 tests on different types of wastewater and all have been certified and authorized by the laboratories of the Mexican Accreditation Agency (EMA).

Last year, the European Medicines Agency (EMA) in London changed its rules to make public the massive amounts of clinical trial data that it receives as part of marketing applications.

The move will allow anyone to see the evidence underpinning EMA's decisions to allow (or reject) medicinal products on the European market.

«Drug agencies like the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) don't actually look at whether people live longer.»

The regulation authorities responsible, such as the European Medicines Agency EMA, now have to decide whether this more conclusive yet more complex test should be required in the future,» says Blanckenhorn.

The European Commission will make the final decision within three months — however, it usually follows the EMA's advice.

The European Commission will have the final say within three months — however, it usually follows the EMA's advice.

These results support the recent announcement on 14 September 2017 that the European Medicines Agency (EMA) has issued a positive opinion for a 1.8 mg naloxone nasal spray formulation (equivalent to 2 mg naloxone hydrochloride), under the brand name Nyxoid.

At the time, it had just been through a mirror version of what it's experiencing now: A nonprofit called the Cochrane Collaboration had requested documents about certain drugs, and EMA had refused.

With few trees to obstruct views, it is one of the best places in the country to watch tapir (Tapirus terrestris), giant anteater (Myrmecophaga tridactyla), maned wolf (Chrysocyon brachyurus), and, of course, the greater rhea (Rhea americana), the large flightless bird related to the ostrich which is locally known as «ema» in Portuguese.

The EMA explicitly rejected phentermine / topiramate twice — first in 2012 and again in 2013.

In contrast to Ciclopirox, approved for topical use, Deferiprone is FDA - and EMA - approved for systemic use (in certain thalassemia patients with iron overload).

However the fact that Ciclopirox is already approved for treatment of patients by the FDA and by its European counterpart, the EMA, and therefore considered safe for human use, may eliminate much of the time and expense ordinarily involved in the drug development process.

«If the EMA makes this knowledge freely available to other companies (in particular to InterMune's competitors) at no cost this could facilitate their development programs and enable them to reach the market and compete with InterMune faster than they would otherwise to be able to do,» writes Jim Goff, InterMune's spokesperson, in an e-mail to ScienceInsider, explaining his company's concerns.

The European Ombudsman, a sort of conduct guard for E.U. institutions, «spent quite a lot of time investigating this, and in the end ruled that we had to release the data,» says Martin Harvey - Allchurch, EMA's head of communications.

The companies filed independent complaints earlier this year, charging that EMA's policy to release information about therapies it has either approved or rejected would put their commercial interests at risk.

Because the ruling applies to only these two cases, EMA plans to keep on releasing other data as individuals and companies request it.

EMA's Harvey - Allchurch explained that one of the requests in question was by a company and another was by an academic.

As a result of the ombudsman's decision, EMA overhauled its policies and has since honored 613 requests for documents and released 1.9 million pages.

But what's clear is that the challenge is the first time EMA's push for transparency has been successfully torpedoed.

EMA's goal is not to make it easier for competitors to manufacture drugs by accessing this information, Harvey - Allchurch stresses.

EMA is discussing how to shape the new policy with academics, patient organizations, and drug companies; their final advice is due by the end of next month.

The European Medicines Agency (EMA) is making good on a promise to become more transparent in an unprecedented way.

Its policy, the EMA said in response to questions, is to make public «all review procedures where the benefit - risk balance of a medicine is under scrutiny.»

However, that still means EMA will lose up to 200 people, Rasi cautioned.

EMA will have to continue paying rent for its London offices because the contract runs until 2039, an estimated total of $ 400 million.

The move of EMA has raised concerns that it could slow down the approval of new drugs, especially if a lot of staff decide not to move with the agency.

Nineteen countries vied to be EMA's new home, though three later dropped out.

Among the European Union's most important scientific agencies, EMA was seen as one of the biggest spoils up for grabs after the United Kingdom's decision to leave the European Union made its more - than -2-decade-old London location untenable.

Amsterdam offers great connections, housing, hotels, and infrastructure, he pointed out, and 81 % of EMA staff had indicated they would move to the Dutch capital, more than for any other city.

Woodcock dismissed comparisons to the EMA.