Kubo makes another donation to Wings for Life UK!

Following on from the ePharma / Pharmacovigilance Day in London this week, Kubo Recruitment would like to thank those of you who took the time to drop by our stand to talk to us and leave us your business card. We have made a donation to our chosen charity, Wings for Life UK for all the business cards we collected. 

 

 

 

 

Kubo to attend 5^th UK ePharma Day 2017! 

 

Kubo Recruitment are excited to be attending the UK ePharma Day 2017 which takes place on Tuesday, June 6th 2017 at the Park Plaza Victoria, 239 Vauxhall Bridge Road in London

This year is the 5^th UK e-Pharma day which examines the implications of the new Clinical Trial Regulation EU 536/2014.  This new regulation marks substantial and important changes in the processes, procedures and documentation necessary for management of clinical trials and relationships between Sponsors, Ethics Committees, Regulatory Agencies and Researchers.  The aim being to streamline bureaucratic aspects through a simple authorisation process by centralising procedures with the consistent involvement of all Member States.

The purpose of this conference is to increase understanding of both fundamental and practical considerations impacting on drug development strategies, management of clinical trials as well as corporate governance related to implementation or the new regulation.

Once again, Omar Ali from the University of Portsmouth and Former Adviser to NICE will be on the scientific board for the event, leading a panel of experts to share best practices, knowledge and experience in this field.  Omar will be joined on the board by, Paul Fardy, VP Data Services at CROS NT and Lorna Griffin, Regulatory Consultant at RApport Strategic Services Ltd.

After the welcome from the scientific board, Lorna Griffin will be the first to speak, providing us with an overview of the major differences between the Clinical Trial Directive and the Clinical Trial Regulation, Lorna will be followed by Leona Fitzgerald who is the Senior Director Regulatory Affairs at PPD.  Leona will be talking about the implementation of the new regulation, its implications for submissions and start-up and the evolution of the sponsor and CRO relationship.

There will also be a number of other speeches including one from Fatma Hindi, Country Project Manager at OPIS France, and Tim Worden who is a Partner at Taylor Wessing LLP

Please drop by our stand to speak to us about career opportunities and/or career advice or your recruitment needs if you are currently looking to hire staff.

We look forward to meeting you!

Kubo donating to World Cancer Research Fund at London Conferences!

Kubo Recruitment are proud to be supporting their chosen charity World Cancer Research Fund, by donating for every card we collect at the ePharma and Pharmacovigilance Days in London on the 17th and 18th October respectively. The conferences will be held at the Park Plaza Victoria hotel in London and we look forward to seeing as many of you there as possible. Please don't forget to leave your business card with us at our stand so that we can raise as much money as possible for this extremely worthy cause. Thank you!

Kubo to attend Pharmacovigilence Day 2016 in London!

Kubo are delighted to be attending this year's Pharmacovigilance Day taking place at the Park Plaza Victoria hotel in London on Tuesday 18th October.

This year's conference focuses on 'Hot Topics in Pharmacovigilance 2016' and there will be expert speakers attending from the industry, regulatory agencies, research bodies, academia and healthcare delivery centres. The topics discussed include the Medical Literature Monitoring (MLM) service of EMA, Social Media screening in Pharmacovigilance, Inspections/Audit Findings, Risk Minimization amongst others.

Kubo will be donating again to their chosen charity WCRF for the amount of business cards we collect at the conference. So please come and visit Kubo to discuss any career opportunities or if you are currently looking to hire, why not see if we can help you with your recruitment needs? Oh, and don't forget to leave us your business card!! We look forward to seeing you there!

The Challenges of Pharmacovigilance: Database and Reporting Solutions

In recent years, regulatory agencies - including the EMA/European Union and the FDA - have taken steps to improve patient safety in clinical trials. The EU estimates that approximately 200,000 patients die each year from Adverse Drug Reactions. Companies are often faced with the challenge of finding solutions that can improve quality and analysis of safety data while managing the increase in data and the need to satisfy regulatory requirements.

In Europe, the latest pharmacovigilance regulations, known as Good Pharmacovigilance Practice (GVP), went into effect in 2012 in order to better analyze and understand data from clinical studies, especially post-market studies, to identify risks to patients. More recently, the EMA has released guidelines for complying with ICH E2B (R3) which regulates electronic transmission of individual case safety reports.

 

Safety Database

 

Companies conducting pharmacovigilance activities will need a safety database that can optimize safety reporting. Many pharmaceutical and biotech companies may opt for Oracle AERS or Argus, while some store safety data in SAS. Oracle AERS is a comprehensive solution for product safety monitoring and compliance. The graphical user interface allows users to visualize the case elements and understand the holistic case picture. Oracle Argus, on the other hand, is a fully integrated platform of end-to-end pharmacovigilance solutions to ensure regulatory compliance from clinical development to post-market surveillance. 

 

Combining statistical analysis, programming and IT support under a commonly used platform like SAS is an ideal solution for automating data collection and analysis from multiple sources. This approach is even appropriate for smaller companies, because automation can be done without a complex or expensive Business Intelligence platform.

 

Customized Reporting Solutions

 

1. Automating signal detection in SAS is one ideal solution for customized reporting. In order to automate the process, a system needs to be in place to pull and analyze data from the safety database. The key aspect is the data integration between safety database, regulatory databases, and patient data from external database resources. The identification of signal criteria and the implementation of standardized programs automates the signal detection process and produces structured data which speeds up the task of finalizing Eudravigilance submissions.

 

2. Integrating an Oracle database with Business Intelligence produces real time data and results. With the support of our technology partner, we can integrate Oracle 9i database with Oracle Business Intelligence Standard One edition to create interactive dashboards for readily accessible data and results.