Updated QRD Template – EU Consultation until 17th August 2012. A revised human medicines QRD (Quality Review of Documents) template for Centralised products has been drafted which addresses the requirements outlined in the recently published Pharmacovigilance Legislation. Read more “Draft QRD Template”
News
Guidance on Submissions to MHRA to be Revised
Regulis representatives recently attended an MHRA meeting, held on forthcoming changes to submission requirements. The MHRA advised that Special Mail 5 guidance is to be revised. Changes will be announced via the MHRA website in due course. Read more “Guidance on Submissions to MHRA to be Revised”
EU Consultation on Variation Guideline 2012
The Variations Guideline which came into force in January 2010 is currently under review with respect to the variation categories and their content. Contributions to this review are invited from all stakeholders dealing with medicines for human and/or veterinary use. Read more “EU Consultation on Variation Guideline 2012”
Eight EMA Finalised GVP Modules now Published
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). Read more “Eight EMA Finalised GVP Modules now Published”
Expanding the Regulatory Team and Expertise at Regulis
Following on from its success in winning the ‘TOPRA 2011 Excellence Award for Support’, Regulis continues to expand its regulatory team with new team members who will help ensure the first class service Regulis aims to deliver to all its clients. Read more “Expanding the Regulatory Team and Expertise at Regulis”
Senior Regulatory Affairs Executive/Project Manager (Medical Devices)
This is a fantastic opportunity to take on a multi-faceted role with strategic influence in an established, yet ambitious and growing company. Read more “Senior Regulatory Affairs Executive/Project Manager (Medical Devices)”
Are you ready for the change?
On 01 July 2011 the EMA announced that the EudraVigilance Medicinal Product Dictionary (EVMPD) – will become mandatory on 2 July 2012. It has been rebranded and called XEVMPD- Extended EudraVigilance Medicinal Product Dictionary. Read more “Are you ready for the change?”
Beyond the Call of Duty
One element of Pharmaceutical and Healthcare companies striving to adjust their business model and maintain their competitiveness, is an increasing trend to outsourcing. In such circumstances the quality of the support provided is critically important. Read more “Beyond the Call of Duty”
Regulis to participate in MHRA pilot
From 3rd January 2012, the MHRA will be performing a technical validation of all new MAA eCTD submissions and Regulis is pleased to be one of the first consultancies to be participating in the pilot. Read more “Regulis to participate in MHRA pilot”
TOPRA Awards Ceremony 2011
Photograph of Regulis being presented with the TOPRA 2011 Support Award. Read more “TOPRA Awards Ceremony 2011”