u/Pharma-1987

Hey everyone,

I recently built a tool that converts CIOMS I forms to E2B R3 (ICH E2B(R3)) XML format for ICSR submissions, and it's performing better than expected. The conversion logic is solid, but now I need to make sure the generated XML is truly valid before trusting it for real submissions.

I tested the output against the FDA FAERS gateway and it passes — which is encouraging. But I want to validate it across other major portals and systems before considering this production-ready.

Looking for advice on:

1. VigiBase / WHO UMC — Is there a test environment or official validator where I can submit E2B R3 XMLs and check acceptance?

2. EudraVigilance / EMA EVWEB — Does EMA have a sandbox or test account for validating ICSRs? Any offline schema/business-rule validators specific to EMA requirements?

3. ICH E2B R3 schema — Is validating against the official ICH XSD enough, or do regional portals layer additional business rules on top that the schema alone won't catch?

4. Other tools or libraries — Any open-source validators, Python/Java libraries, or third-party tools that go beyond XSD and check ICSR business rules?

The tool handles the structural conversion well — FDA validation confirms that. But I want to make sure it holds up against WHO and EMA requirements too before calling it done.

Any workflows, tools, or sandbox access tips would be really appreciated!

I work in pharmacovigilance outsourcing and we interview PV candidates regularly for our process. Here's what I see:

Oversold by training programs:

- "ICH E2E knowledge" listed as a skill (it's a guideline, not a skill)

- MedDRA coding theory (just as only in CVs) with zero practical coding experience

- SUSAR writing listed without understanding of expedited reporting criteria

Actually in demand:

- Practical E2B(R3) XML submission experience

- Literature screening with gap analysis documentation

- Case narrative writing for complex/serious cases

- Signal detection using real tools (Empirica, EVDAS, or even R)

- Understanding of company-level aggregate report timelines (DSUR, PBRER)

The gap between PV education and industry needs is wide. If you're studying PV, focus on hands-on tools over theoretical knowledge.

What skills do you wish someone had told you to develop earlier?

Hello Drug Safety experts,

I have a quick question regarding a drug safety database I’m developing for my own workflow/process, similar in concept to Argus/ARISg. I have a few areas where I’m uncertain and would appreciate your insights.

1. WHO Drug dictionary – I understand WHO Drug requires a subscription. I’ve been testing with alternative dictionaries for product coding. Is WHO Drug considered essential for product coding in practice, or can other drug dictionaries/custom dictionaries be implemented effectively?
2. E2B implementation (R2/R3) – I’m currently implementing E2B import/export functionality. Is there any precise or recommended documentation for the XML structure used in E2B R2 and R3 formats?
3. Regulatory submissions / gateways – I understand many regulators still allow manual submission, but there are also Electronic Submission Gateways (ESG) for direct ICSR transmission. Are there any good references, implementation guides, APIs, or documentation for integrating regulatory transmission functionality?

I’d really appreciate advice from anyone who has worked on pharmacovigilance systems, ICSR processing, or E2B implementations.

Thanks in advance!

Hi everyone,

I’m currently developing two tools based on the same concept: a literature search and review tool. One is a CLI-based tool, and the other is a GUI/web application.

• The GUI version is in pre-launch/testing and is available at: www.lixplore.com
• The CLI version is open-source and available here: https://github.com/pryndor/Lixplore_cli

Both tools essentially provide the same functionality and outputs, aligned with end-user expectations. At the moment, the CLI tool is evolving and emerging, particularly around download.

I’m considering focusing only on the CLI tool—keeping it free, maintaining it consistently, and discontinuing the GUI version (Lixplore).

From your experience and perspective:

• Is this a reasonable decision?
• What potential impacts (positive or negative) should I consider before making this move?

Appreciate any insights or suggestions.