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Are you still relying on outdated frameworks for compliance and leadership?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...

Expect these common questions during interviews and audits 👇👇

🎯 Ace your next regulatory interview for the US & EU by demonstrating knowledge

🧾 What is a Marketing Authorisation Application (MAA)?

The MAA is a formal request to the European Medicines Agency (EMA) or national authorities to approve a medicinal product for marketing in the European Economic Area (EEA) — including all 27 EU Member States, Iceland, Liechtenstein, and Norway.

A successful MAA leads to the Marketing Authorisation (MA) — legally allowing the product to be placed on the market.

🔄 Types of EU Approval Procedures for MAA

The route you choose depends on the product type, target countries, and legal eligibility. There are four main routes:

1. ✅ Centralised Procedure (CP)

📌 Mandatory for: Biologics, Advanced Therapies, and Orphan Drugs

New Active Substances for: HIV/AIDS, cancer, diabetes, neurodegenerative, auto-immune, and viral diseases Products made using biotech processes (e.g., recombinant DNA) Medicines for rare diseases (Orphan Designation)

📝 Submit to EMA.

Evaluation done by CHMP (Committee for Medicinal Products for Human Use).

Approval by the European Commission. One single marketing authorisation valid in all EU/EEA countries.

2. 🌍 Decentralised Procedure (DCP)

📌 For products not yet authorised in any EU country

When simultaneous approval in multiple EU countries is desired for generic drugs, well-established use, or products not falling under Centralised

📝Choose a Reference Member State (RMS) and Concerned Member States (CMSs). Submit dossier to all states at once. RMS leads scientific review and shares with CMSs. If consensus is reached, each country grants national MA.

3. 🔁 Mutual Recognition Procedure (MRP)

📌For products already approved in one EU country (RMS)

You want to extend approval to other EU/EEA states (CMS)

📝 Submit the existing MA and data to additional countries.

RMS shares original assessment report. If CMSs accept it, national approvals are granted.

4. EU National Procedure

📌Only when the product will be marketed in one country.

Each country has its own specific rules (e.g., Germany – BfArM, France – ANSM, etc.)

💬Comment: "Free session"

If you want to know more about:

- How to develop and build a global regulatory strategy?

- How to plan and execute global clinical trials efficiently?

✅ Essentials of Safety Data Exchange Agreements (SDEA) / Pharmacovigilance Agreements (PVA)

🔍Many compliance failures in pharmacovigilance stem from poorly written or ambiguous agreements between MAHs/Sponsors, CROs, license partners, Importers/Distributors and affiliates.

📌 Join us for this power-packed online free training session — perfect for interview preparation and real-world implementation.
- What makes a strong, inspection-ready SDEA/PVA
- How to define roles, responsibilities, territories, and timelines
- Aligning with EU & US regulatory expectations
- Common pitfalls that lead to regulatory findings

👥 Who should attend?
- Pharmacovigilance professionals
- SDEA & PV Agreement Managers
- Regulatory Affairs teams
- Quality Assurance (QA) personnel
- Legal/Compliance teams
- Clinical Operations leads
- MAHs, CROs, CDMOs, and License Partners

🗓️ Date: 09 August 2025
🕕 Time: 6PM to 7PM IST
🌍 Region: US | EU | UK | APAC

🎯 Let’s build smarter agreements that stand up to regulatory scrutiny and ensure compliance across global markets.

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

Post 5:📌 ICSR series - Causality Assessment tools 👇👇

✔WHO-UMC Scale: Categorizes cases into - Certain, Probable, Possible, Unlikely, Conditional/Unclassified, and Unassessable

✔Naranjo Algorithm: Quantitative score-based system (Definite, Probable, Possible, Doubtful) using a 10-question criteria

Other methods:

- Case-by-Case Assessment (most used and requiring medical knowledge and clinical judgment skills)

- CIOMS scale (used rarely)

❓Smart question during the interviews :Why do you use the above tools?

Impress the interviewer by saying: "These tools serve only as a reference, but thorough medical and clinical judgment should be applied to make decisions."

📩 GPLACO SOLUTIONS can provide expert guidance to companies on implementing best practices for AI/ML-driven causality assessment models to standardize processes, improve consistency, and reduce subjectivity in decision-making. Let’s talk!

Differences between the US FDA and EU PV guidelines👇👇

📥 Download for reference during interviews.

In the upcoming series of posts, we will dive deeper into specific areas and procedures to better understand the key differences. Stay tuned!

Winning Pharmacovigilance strategies:👇👇
Learn how to effectively deal with the major challenges and implement:
- Robust PV agreements/SDEAs
- Effective Individual Case Safety Reports (ICSR) monitoring
- Literature surveillance & screening process
- High quality aggregate/periodic reporting
- Quality assurance (QA) framework
- Root cause analysis (RCA) and develop corrective and preventive actions (CAPA) to mitigate risks.

PV Interview question: Can you name some GVP modules? 😇😇

Remember to mention - 5, 6, 7 and 9👇👇