ozyTRACK is a tool developed by FMD K&L for the purpose of addressing the challenges faced by medical professionals in the form of a constantly evolving E2B R3 regulations from the EMA. ozyTRACK is an Auto-match, Monitoring and BFC Conversion of MLM literature/R3 for faster compliance with Regulations. The details of this tool is illustrated through the course of this document
The European Medicines Agency (EMA) is responsible for monitoring a number of substances and selected medical literature to identify suspected adverse reactions with medicines authorized in the European Union, and for entering the relevant information into the EudraVigilance database.
In line with the guidance in Good Pharmacovigilance Practices (GVP) Module VI, marketing-authorization holders are required to monitor medical literature and to report individual cases of suspected adverse reactions for medicines for which they hold a marketing authorization in the EEA.
1 Legal background
The legal basis for the EMA’s tasks is Article 27 of Regulation (EC) No 726/2004External link icon, which states that:
- The Agency shall monitor selected medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances. It shall publish a list of active substances being monitored and the medical literature subject to this monitoring;
- The Agency shall enter into the EudraVigilance database relevant information from the selected medical literature;
- The Agency shall, in consultation with the Commission, Member States and interested parties, draw up a detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database.
- MAH shall monitor all other medical literature and report any suspected adverse reactions.
- MAHs shall apply to the recording and reporting of suspected adverse reactions for medicinal products for human use authorised in accordance with this Regulation
- For the purpose of the literature-monitoring service to be provided by the Agency in line with Article 27of Regulation (EC) No 726/2004, the structures and processes as outlined in GVP Module VI apply accordingly.
2. Business Process
2.1 Agency Business Process
In accordance with GVP Module VI, the purpose of the screening, review and assessment process is to identify valid Individual Case Safety Reports (ICSRs), filter duplicates, perform MedDRA coding/assessment and finally, publish the potential ICSRS in Download area.
2.2 MAH Business Process
MAHs access and download the ICSRs from EudraVigilance or a dedicated area of the EudraVigilance website. Documented quality controls should be in place to ensure timeliness, accuracy, and completeness of the processing of confirmed ICSRs. For ICSRs which refer to suspect or interacting medicinal products/substances other than the substance groups subject to the monitoring by the Agency, MAHs should not report those ICSRs separately to the concerned NCA(s) in the EEA or the Agency as applicable to avoid duplication of reports.
2.3 SOP of MAH
To adhere to EMA regulations MAH has to perform the following list of activities;
- Get bulk of R3 ICSR cases from EMA
- Extract the suspect drugs, its active substance, and seriousness of the ICSR cases.
- Verify against company product dictionary.
- Include the relevant for further processing and exclude the ICSRs that are irrelevant.
- Filter out duplicate cases
- Review & verify the inclusion and exclusion list.
- If required, convert R3 to R2
2.4 Process cases to the local safety system, perform assessment and coding and submit back cases as per defined timelines based on the seriousness of the case
- Ensures conformance to specification and identification of process areas for improvement and be audit ready. The audits are to be performed by an independent auditor appointed by the Agency.
3 Proposed Solution for MAH
3.1 Input to System
The system shall accept inputs from various possible means from EMA download area;
- Manual Upload with Drag and Drop interface
- Monitoring Inbound Folder on a scheduled frequency
- Scanning email account on a scheduled frequency
- Reading from EV Web services
3.2 Input Format
The system shall accept various format;
- Importing ICH E2B R3 XML file
- Importing ICH E2B R2 XML file
- Importing of Zip file (with R3 and/or R2)
- Adobe PDF CIOMS
- MS Word
3.3 BFC Transformation
The system shall perform required transformation and generates comparison reports;
- Perform Upgrade, ICH E2B R2 to ICH E2B R3
- Perform Downgrade, ICH E2B R3 to ICH E2B R2
- Detailed comparison report on conversion
- Download various format of comparison reports, Batch or Individual case files
- View attachment
- Zero data loss due to erroneous conversions.
3.4 Manage Knowledge Repository for Products details
The system shall maintain a repository of Products;
- Synchronize Product dictionary from Safety Database
- Update/manage the Product Knowledge repository
- Flag product for inclusion and exclusion list
3.5 Extract, evaluate and help in the assessment of cases
The system shall extract received ICSR cases, extract fields and helps in Triaging;
- Evaluate weightage & Ranking as per configured algorithm
- Perform Auto-Accept based on weightage
- Perform Auto-Reject based on Knowledge repository (Rejected list)
- Perform Duplicate check based on the configuration
- Deliver duplicate summary report
3.6 Observing & Machine learning skills
The system shall have machine learning capabilities.
- While decision are made that is out of the current repository, the system shall observe decision made and learns and update knowledge repository
- Machine Learning with supported Manual Re-Training
- Any new similar cases received would be evaluated based on earlier evaluations/assessment
3.7 End to End Reconciliation, Tracking, and Monitoring
The system shall provide various reports, the tracking mechanism for Audit and Reconciliation;
- Safety DB Case Number recording and tracking
- Case lifecycle Tracking and reconciliation report with various filters
- Archive feature
- Transactional Progress Status
- Detailed log to analyze performance, failures, duration etc.,
- Advanced & Customized Notification messages on various events like on error, auto process, duplicates etc.,
- Manage entire transaction with Simple workflow
3.8 Customized and fully automated
The system shall be customized and configured to make it fully automated;
- Inputs, evaluations, notification, acceptance/rejection and submitting of the case to Safety System, all these tasks shall be automated
- ozyTRACK is an innovative Auto-match, Triaging, Monitoring & BFC Conversion of MLM literature/R3 to quickly achieve compliance with evolving E2B R3 regulations from EMA. The application provides seamless integration with most of the leading safety systems and meets all the latest regulations.
- ozyTRACK can be integrated with Email Server, EV-Web Services or physical folder for automating system completely.
- Compares cases in MLM/R3 or ICH E2B R2 files against approved company maintained master product dictionary (MPD) and accurately identifies MAH cases by using the latest robust Robotic Process Automation (RPA) mechanisms.
- It applies various Complex Search/Matching Algorithms, Artificial Intelligence (AI) and Machine Learning techniques.
- System has a robust search algorithm that evaluates weightage based on execution.
- ozyTRACK – Seamless, Simple yet powerful tool to helps organizations to meet new regulatory requirements.
- ozyTRACK is a pre-validated tool offered as a cost-effective solution for companies with safety databases that requires cherry-pick cases and also that are unable to import E2B R3 files.
- ozyTRACK also eliminates the immediate need to upgrade the Safety Databases and bring quick compliance with zero changes to their current Safety Systems.
- ozyTRACKis fully compliant with EMA latest regulations and brings an innumerable efficiency and case monitoring, tracking, triaging and audit-related capabilities. Its comparison reports, transformation- mapping flexibility and configurable settings wins hands down over other competing solutions in the market.
- ozyTRACK comes in various offering models to suit every sized customer’s needs. We offer both hosted, on-premise and other workable business models to meet each customer’s requirements.
ozyTRACK remains the clear choice of customers and wins hands down over its competition
|CFR||Code of Federal Regulations|
|GAMP||Good Automated Manufacturing Practice|
|GMP||Good Manufacturing Practice|
|SOP||Standard Operating Procedure|
|URS||User Requirements Specification|
FMD K&L – Company Overview
FMD K&L is a 21-year-old Contract Research Organization (CRO) offering Pharmacovigilance, Medical Writing, Regulatory Affairs, Toxicology, Business Accelerator Development, Clinical Trial Management, Data Management, Biostatistics, Statistical Programming and CDISC-compliant eSubmission services to pharmaceutical, biotechnology, and medical device industries worldwide. FMD K&L presently works with six out of ten leading pharmaceutical companies and several small to midsize companies across the world through our well-established Centers of Excellence. FMD K&L with a total employee strength of more than 1400, has a wide geographical coverage with 19 offices across the the USA, UK, Philippines, India, China, South Korea, Japan, Taiwan and Armenia.