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Tag Archive: regulations
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.
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Pharma’s Practical Next Steps for Social Media
What’s Next: Practical Steps for Pharma's Increased Social Media Participation
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Bart’s Corner: Proposed MedWatch Changes
On December 11, 2014 FDA published in the Federal Register a notice about proposed changes in the MedWatch forms (3500A and B) for post-marketing SAE/AE reporting. The changes are largely cosmetic, though there is some increased collection of ethnic subgroup information. The proposed changes are detailed below. First, however, FDA[…]
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Bart’s Corner: REMS Update
In September 2014 FDA issued a paper on Standardizing & Evaluating Risk Evaluation and Mitigation Strategy (REMS). A REMS is put in place for those products to ensure that benefits outweigh the risks. REMS may require additional measures above and beyond the usual post-marketing safety surveillance by the sponsor. This[…]
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Bart’s Corner: PV Crises
This is a follow up to the previous posting on PV Stress Tests. During every PV person’s career, a “PV crisis” will arise. PV “crises” can occur in clinical trials or during marketing and may be of varying degree and type; so let’s define them first. Although the following are[…]
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5 Keys to Choosing the Right Healthcare IT Partner
As I mentioned in my last post, choosing an IT solutions provider is a critical decision for all healthcare leaders in their quest to stay competitive and offer cutting-edge technology. Here are 5 factors to consider when choosing the right healthcare IT partner: Cloud-Based Aptitude The future of the healthcare[…]
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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[…]
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Bart’s Corner: Escalating Signals and Safety Issues
In modern day pharmacovigilance (PV) and Drug Safety (DS), whether it is done in companies or health authorities, it is absolutely necessary to have in place a mechanism both to identify safety issues and then to act on them. There has been much discussion about the identification of safety issues[…]
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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[…]
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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[…]
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