Gplaco Solutions - AI/ML enabled services

🎉 New Year New Learning 🎈 New Opportunities 🎊

GPLACO SOLUTIONS brings you a high-impact, real-world training program on:

How to perform - Signal Detection & Management for the US, UK & EU?

An online training paid session for - MAHs / Sponsors, CROs, and Solution Providers!

What does the Program include?
✔️ End-to-end Signal Detection – step-by-step practical ex*****on
✔️ Signal validation, analysis, and prioritization using real examples
✔️ FDA & EMA signal tracking – how it is actually done in practice
✔️ Action planning, decision-making, and signal closure
✔️ Implementation of SOPs and Work Instructions (WIs)
✔️ Practical training models for signal management teams
✔️ Establishing and operating an effective Safety Data Monitoring Board (SDMB)

Program Details:
📅 Dates: 28 & 29 January
⏰ Time: 7:00 to 8.30 PM IST (90 Minutes)
🕒 Duration: For 2 Days

Last date to Register and complete the payment - 15 Jan 2026!

💥 ATTENTION PV & Regulatory Professionals: 👇👇

Are you still relying on outdated frameworks for compliance and leadership?
The landscape of Pharmacovigilance (PV) and Regulatory Compliance is evolving faster than ever.

To stay audit-ready and advance your career, you need mastery in both technical ex*****on and strategic leadership.

💡 Introducing the 2026 (JAN-MAR) Global Professional Development Series:

Technical Vs Leadership programs 😇

We’ve distilled the most critical, audit-proven knowledge into two specialized tracks — designed to empower professionals across the US, UK, EU, and India. All are online/remote and paid sessions.

1️⃣ TECHNICAL TRACKS: Master the Core (Min 3 to 5yrs exp in ICSRs required)
Develop the skills for flawless compliance ex*****on — from SOPs, SDEAs, DSURs, Signal Management, RMPs to PSMF readiness.

2️⃣ LEADERSHIP TRACKS: Drive Strategic Governance (Managers and above only)
Elevate your leadership edge with QMS implementation, vendor oversight, governance, and GVP audit preparedness.

🌍 Global Schedule
US: Tuesdays & Thursdays, 9:30–11:00 AM EST
EU: Tuesdays & Thursdays, 3:30–5:00 PM CET
India: Tuesdays & Thursdays, 7:00–8:30 PM IST

🚀 Ready to lead your team to audit success?

View the full program outline and register today only by emailing:
📧 [email protected]

The details about the sessions and fees will be shared by email.

✅ SDEA and PVAs: Insights & Practical Takeaways👇👇

Our recent training session on Safety Data Exchange Agreements (SDEA) and Pharmacovigilance Agreements (PVAs) was a great success! 🎯

📌 Missed it?

Watch the video to gain valuable content, interview preparation tips, and real-world ex*****on insights.

💬 Comment below the video on which topic you’d like us to cover next in our upcoming videos!😊

https://youtu.be/xn5viWvGqpY

#SDEA #PVA #Pharmacovigilance for the US & EU Agreements Interview preparation on Safety Data Exchange Agreements (SDEA) & Pharmacovigilance Agreements (PVAs) for the EU & US. Learn about the details of the agreeme...

Post 6: 📌ICSR Case Narrative Writing: Is it an art?

- Initially yes, but after a little bit of practice it is quite easy!!

Interview question - How do you write narrative?
❌ - I just follow the client/customer template
✅ Talk about the chronology, history, event term, product and outcome

What are the best practices, common mistakes & key takeaways 👇👇
✔ Maintain a clear, structured format in case narratives

✔ Ensure clinical accuracy by verifying information against source documents
✔ Avoid copy-pasting to minimize oversight errors
✔ Conduct thorough quality checks to catch inconsistencies or missing details
✔ Ensure MedDRA coding consistency for adverse event descriptions
✔ Train teams to write concise but comprehensive narratives that meet FDA/EMA expectations
✔ Standardize global narrative writing SOPs to align with FDA, EMA, and MHRA requirements