EMA Recommends Suspension Of Medicines Over Flawed Studies At Semler Research Center
The European Medicines Agency (EMA) has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Center Private Ltd, Bangalore, India.
The Agency has also recommended that medicines currently being evaluated for authorisation and which rely only on bioequivalence studies from this site should not be authorised until bioequivalence is demonstrated using alternative data. Bioequivalence studies usually form the basis for approval of generic medicines.
EMA’s review followed an inspection conducted by the Food and Drug Administration (FDA) that identified several issues at Semler’s bioanalytical site, including the substitution and manipulation of subjects’ clinical samples. The World Health Organization (WHO) also raised serious concerns regarding data integrity and manipulation of study samples following its own inspections of Semler’s bioanalytical and clinical sites. (Romania Libera)
87% Of Doctors Refuse To Work Extra Shifts Unless They Get All Their Rights
Most doctors in Romania (87%) working shifts have refused or they are going to refuse to sign the individual labor contracts for additional work shifts unless they are granted all their rights, as they have publicly demanded, according to a survey ordered by the “Sanitary Solidarity” Federation.
The survey also shows that nearly 73% of doctors who have already been asked to sign the individual labor contracts, refused to do so, even in the context of pressures by hospitals’ managers. Moreover, nearly 10% of doctors said they were asked to sign these labor contracts for the additional work shifts, and 6.2% of respondents spoke about being pressured by hospital managers into signing the new contracts.
The survey was conducted on a sample of 1,000 doctors working shifts. (Puterea)
Nearly 30% Of German-Held Romanian Firms Think Economy Is Doing Well
Nearly 30% of German-held Romanian companies think the economy is doing better currently than in the previous year, according to a survey conducted by the German Chambers of Commerce in Central and Eastern Europe.
Romania places above the average of countries in Central and Eastern Europe regarding the economic evolution, according to the survey.
However, 56% of respondents think the situation of the Romanian economy remained unchanged. (Adevarul)
Liberal Party Leaders Likely To Resign After Fall Elections – Sources
Sources within the National Liberal Party (PNL) said the party leaders, Alina Gorghiu and Vasile Blaga, are going to resign from their positions after the parliamentary elections due in fall.
The same sources said the party will elect, at the congress to be held in the spring of 2017, its new head who will also be the new prime minister. However, it all depends on the party’s results at the elections in fall. (Evenimentul Zilei)
Political Parties Ready Lists Of Candidates For Fall Elections
Political parties in Romania are readying the lists of candidates for the parliamentary elections due in fall.
Sources within the National Liberal Party (PNL), quoted by Mediafax, present the criteria considered when completing these lists and they even give names and surnames of lawmakers who will no longer enjoy eligible positions.
Other sources say the head of PNL’s Bucharest branch, the controversial Cristian Busoi, has initiated all rumors, for the purpose of strengthening his position and controlling who gets to be put on the list and who does not.
Liberal lawmakers Ludovic Orban, Razvan Mironescu and Diana Tusa do not stand much chance of enjoying eligible positions on the lists of PNL’s Bucharest branch for the parliamentary elections. (Puterea)