SAFETY PLANNING & EXECUTION FOR ICH E2B R3:
With new ICH E2R Requirement around the corner,there is a need for either short term or long term solutions to meet this new challenge. Immediate solution is to upgrade your adverse event reporting system to E2B R3 compliant version or a short term solution to build a transformer tool/Accelerators that will help to convert the E2B R2 TO E2B R3.
Pharma and CRO will need a significant investment in organization change management to ensure adoption and execution to stand in align with this new regulation to make them 100% compliant.
Key Question against the Life science Organization:
Q1: What are the Major Changes in ICH E2B R3 as per my product Portfolio ?
Q2: Is our system able to handle the new regulation changes, if not what is the immediate action needed ?
Q3: Do we have the knowledge and expertise in ICH E2B R3 ?
Q4: Do we know the New Validation as per ICH E2b R3 and if our system adhere to those validation rules ?
Q4: How would the regulatory Audits handled after transition to R3?
Q5: What are the changes validation rules going to change at the receivers end so we do not get rejections from the Partners and Agencies?
With excellent understanding of the new ICH E2B R3 regulation and expert from the Drug Safety Domain,our team help the customer to plan for this new change by assessing the impact on its business processes s due to this new major change in health care arena.
Below are key offering:
- Change Preparation –
We conduct workshops to find out what logistics needed for pharma companies to be prepared with this change . We help to capture the business requirement arises due to this change that will focus on key functionality change. Integration needed if any with existing downstream system. We identify what is the new fields needed as per the product portfolio and as per the local drug safety unit requirements.
2. Alignment of Business Processes.
After the complete change is documented, we develop Accelerators that focuses on alignment of existing business rules with new rules.Create a road map to achieve 100% compliance. Come up with the complete mapping documents. Identify the most optimum solution by understanding the regulatory requirement and deadlines for each regulatory agencies.
3. Technical Solution meeting business requirements:
This step will identify if accelerators or some tool or upgrade will meet the Organization need to meet the compliance against these new set of regulations.
DBA Systems experts also has knowledge of XML with XSD technology that will help to identify and come up with best solution approach.Technical POC can be conducted to finalize the solution.Extension solution of the DTD element can be developed as per the business need and ICH BFC Validation schema files can be updated with the inclusion of these new DTD element.We setup environment and offer the complete testing with FDA/EMA to make sure files with R3 is getting acknowledged with positive acknowledgment.
3. Developing a communication plan.
Develop a plan on how this new solution can be communicated among the business stakeholders including the receivers of new R3 Files. Find out the training needs among the business users including the reporting officers responsible for report transmission.
4. End User Training.
Facilitate and conduct internal and client training to feel comfortable about this new change.
For More Information about the ICH Guidelines, Follow the link below: