In 2021 the United Kingdom is moving to its post-Brexit life with new processes, procedures, and laws everywhere, including clinical trials and pharmacovigilance. This piece we dedicate to a simple question – how to move to post-Brexit pharmacovigilance effortlessly and efficiently.
Who: Marketing Authorisation Holders (MAH) of medicines authorised in Great Britain
Where to submit: to the MHRA
What to submit: all pharmacovigilance data, including
UK and non-UK Individual Case Safety Reports (ICSRs)
Periodic Safety Update Reports (PSURs)
Risk Management Plans (RMPs)
Post-Authorisation Safety Studies (PASS) protocols and final study reports
Flex Databases Pharmacovigilance is here to help you with the new MHRA Gateway submissions of ICSRs.
Submitting Individual Case Safety Reports
As the MHRA states, “We will require submission of all UK (including NI) ICSRs (serious and non-serious) and serious ICSRs from other countries via the new MHRA Gateway or/ICSR Submissions portal which have been developed.”
How we proceed:
The MHRA recommends registering for submissions “as early as possible”.
Move to compliant PV system within a month before regulation changes? We say let’s do it!
To start moving to post-Brexit pharmacovigilance, request a quote or learn more request a demo via the button on top of the page, or send us an e-mail to firstname.lastname@example.org!
It helps to optimize and automate the most important aspects of any clinical trial process – monitoring, grants & subjects, and sites
It provides easy capability for financial management, study monitoring, feasibility assessments, and other needs
It is a secure and validated PV system that serves as a single point of entry, assessment, and reporting of safety data
Baseline implementation takes only 5 weeks!
Tranquil clinical research was created to ensure that the entire clinical trial, device, and drug development process is conducted with ethics and the patient in mind first and always. The business model ensures a client’s drug, device or investigational product in the clinical trial is adherent to the highest level of quality and integrity in the services company provides.
We’ve asked Dr. Anton Klingler, CEO Assign DMB and Mag. Sabine Haid, Lead Project Manager, a few questions about the upcoming partnership:
Why Assign DMB decided to pick Flex Databases as a provider for CTMS, TMF, and Pharmacovigilance?
Assign DMB is always in search of innovative new electronic systems to cover clinical trial processes. We want to amend our portfolio of electronic systems to offer more flexibility to our clients.
Assign DMB experiences that Flex Databases is very customizable as the product range is organized in modules which can be selected as needed. We decided to pick Flex Database as the offer, the presentations and the customer support were very tailored to the needs of Assign DMB with short turnaround times, and as you cover applicable regulations like 21 CFR Part 11.
What do you expect to achieve with the implementation of Flex Databases?
Assign DMB expects:
to reduce time in managing essential documents in the TMF, while increasing quality
to have a streamlined and clear process in managing safety cases in the pharmacovigilance database
to ease the documentation process of monitoring visits and site documentation within the CTMS system
to offer its clients a one-stop-shop access to their essential data and documents in order to keep oversight of their clinical trials
to manage all its trials in the module project catalogue which increases the oversight and assists in resource planning
Assign DMB – is an organization in Western Austria with primary focus on clinical research data:
Project Oversight Management
Long-time experience allows Assign DMB to manage your clinical study tailored to your individual needs ensuring highest quality standards.