Posts Tagged ‘EMA’

Now that December is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in November – they’re ranked in order of popularity, with number one being the most viewed piece. Top 25 Biotech Companies European […]

Pharmaceutical companies selling their products in the UK need to consider the impact Brexit will have on their operations. Some changes will need to be made before the UK leaves the European Union on March 30, 2019. In a press release, the European Medicines Agency (EMA) said: “The guidance document outlines the practical and simplified […]

The European Medicines Agency (EMA) is will be moving its offices from London to Amsterdam, due to the UK’s decision to withdraw from the European Union. According to a press release issued by the EMA, the relocation effort needs to be completed by the end of March 2019. The EMA currently employs close to 900 […]

We are quickly coming up to the go-live of the MedDRA 20.1 dictionary. The new version; maintained by the MSSO was released in September 2017; per regulatory guidance will go live on the first Monday, two months after its release. This version, 20.1 will be live 06Nov2017. Our clients often have questions about upgrading their […]

Now that June is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in May – they’re ranked in order of popularity, with number one being the most viewed piece. How To Import Data Into Siebel […]

E2B(R3) So, there we have it, the European Medicines Agency (EMA) has finally issued a statement, which confirms the date of release for the bigger, better EudraVigilance: November 22, 2017. Time to go into panic mode? Absolutely not. But, here are some of the things you should be thinking about as the deadline approaches: Training […]

In the European Union, the use of E2B(R3), along with IDMP, is in legislation, so not complying by the deadline could have legal repercussions. Non-compliance with the FDA and MHLW’s requirements could also bring unwanted scrutiny. More importantly, if an organization does not comply by the deadlines, they will not be able to send ICSRs […]

Yes, some validated systems can comply with E2B(R3). With respect to Oracle Argus Safety, the current version, 8.0.1, is able to comply with E2B(R3), Electronic Vaccine Adverse Event Reporting System (eVAERS), and Electronic Medical Device Reporting (eMDR) reporting requirements. If a company is simply looking to meet E2B(R3) requirements, we advise waiting to upgrade until […]

Now that August is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in July – they’re ranked in order of popularity, with number one being the most viewed piece. When Do Companies Have To […]

The issue is not the type of system used to collect adverse event data, but rather how the data is submitted to the FDA, EMA, and MHLW. If an organization is using spreadsheets to collect safety data or is unable to transmit data via E2B, it will have to report the data via a web-based […]

Companies who are currently submitting reports using the E2B(2) format should already be planning the move to E2B(R3). If a robust safety and pharmacovigilance system is already in place, there are likely just a handful of technical changes that need to be made in order to meet the new regulations. For example, system configuration changes […]

In the United States, if a company is transmitting vaccine or device information to the FDA, it should already be reporting in E2B(R3) format. For companies reporting solely to the FDA Adverse Event Reporting System (FAERS), no official deadlines have been published. In Europe, drug companies who report to the EMA will need to comply with […]