The Experience Matters. Let us show you why.
Contact us today.
Tag Archive: EU
Laws, Regulations, Guidances, Guidelines and Best Practices
Bart Cobert attempts to clear up the confusion around Drug Safety and PV requirements in different regions of the world, with a focus on US and EU requirements.
Read More
Brexit, Again
The UK has given official notice that they will withdraw from the EU. With Brexit seemingly moving ahead, Bart Cobert looks at its effects on the world of pharmacovigilance.
Read More
Brexit and Pharmacovigilance
What effect will Brexit have on the world of Pharmacovigilance?
Read More
The French Phase I Trial Disaster
Bart Cobert discusses the lessons learned from the recent Phase I trial disaster in France.
Read More
EudraVigilance Stakeholder Change Management Plan
EMA Changes to EudraVigilance (EV), ICSR reporting and SUSAR reporting
Read More
Bart’s Corner: Danish HA Guide on PV
In June, the Danish Health and Medicines Authority (DHMA), issued its Guide to Individual Case Safety Reporting. This is a 60 plus page “best practice” (their words) document describing the process for submitting individual case safety reports (ICSRs) to them using the E2B standard to “complement current EU legislation and[…]
Read More
Monitoring Medical Literature: EU Changes
The EU and FDA have required Marketing Authorisation Holders (MAHs) to monitor medical literature for adverse drug reactions for many years. The EMA has finally put forth the details of its new system to monitor medical literature for MAHs.
Read More
Bart’s Corner: EU Proposals on Updates for Good PV Practices
On September 15, 2014, the EMA published proposals on changes to the Good Pharmacovigilance (PV) Practices covering revisions of Module VI on the management and reporting of adverse reactions In particular post-authorisation safety studies and on Module III on new Union procedures for pharmacovigilance inspections. There is a request for[…]
Read More
Bart’s Corner: Update on EMA Risk Management Plans (RMPs)
In April of this year the EMA announced the first public summary of an RMP, in this case for the drug Neuraceq [florbetaben (18F)] The EMA also published an update of their webpage on RMPs, which noted that the revision to the Good PV Practice RMP module – Module V[…]
Read More
Bart’s Corner: EU Pharmacovigilance Inspection Update
Several documents were published by the EMA and went into effect in June 2014 regarding EU Pharmacovigilance (PV) inspections. Some of the more important points are summarized here: Inspection Findings Impacting the Benefit-Risk Profile The Pharmacovigilance Risk Assessment Committee (PRAC) adopted a new procedure entitled: “Union procedure on the management[…]
Read MoreThe Experience Matters.
As an industry leader in business process outsourcing, HCL Technologies delivers global, multi-channel engagement solutions. The Experience Matters. Let us show you why.
Contact Us