As of 1st November 2017, this agreement, which updates the agreement from 1998, allows for recognition of each other’s inspection outcomes and hence for better use of inspection expertise and resources. In June, the European Commission confirmed that the US Food and Drug Administration (FDA) has...
As of 1st November 2017, this agreement, which updates the agreement from 1998, allows for recognition of each other’s inspection outcomes and hence for better use of inspection expertise and resources. In June, the European Commission confirmed that the US Food and Drug Administration (FDA) has...
Have you been in doubt whether or not your wholesale distributors would require a Pharmacovigilance agreement? There are instances where your company might be not sufficiently clear on which are the main factors that need to be analised to establish or not a Pharmacovigilance agreement. The...
Have you been in doubt whether or not your wholesale distributors would require a Pharmacovigilance agreement? There are instances where your company might be not sufficiently clear on which are the main factors that need to be analised to establish or not a Pharmacovigilance agreement. The...
EMA launches survey to assess whether patients and doctors are aware of the arrangements for reporting of side effects. The deadline for completing the 10 minute questionnaire is approaching! (9 October 2017) and its results will be published in 2018. It will be quite interesting to follow...
EMA launches survey to assess whether patients and doctors are aware of the arrangements for reporting of side effects. The deadline for completing the 10 minute questionnaire is approaching! (9 October 2017) and its results will be published in 2018. It will be quite interesting to follow...
It is coming soon! The new Eudravigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions will become operational on 22 November 2017. The document with Questions & Answers from stakeholders “The launch of the new EudraVigilance System” has been recently updated and it is...
It is coming soon! The new Eudravigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions will become operational on 22 November 2017. The document with Questions & Answers from stakeholders “The launch of the new EudraVigilance System” has been recently updated and it is...