OshVi Solutions

08/03/2026

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21/02/2026

🌍 Staying compliant in Pharmacovigilance is getting tougher. Are you up to speed?
Here is your weekly roundup of major PV and drug safety updates from around the world, brought to you by OshVi Solutions! 👇
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🌐 Global Milestones
🤝 FDA & EMA Team Up: A new "cluster on PV topics" has been formed for monthly data sharing. They also reinforced their "10 Guiding Principles" for AI integration in PV!
Australia (TGA): Mandatory reporting expanded for device-related adverse events.
South Africa (SAHPRA): Introduced an accelerated reliance pathway.
📚 CIOMS: Updated their PV glossary to officially include AI terminology.

🇪🇺 European Union (EMA & PRAC)
🚨 Market Withdrawal: Levamisole is being withdrawn across the EU due to severe risks of leukoencephalopathy.
📜 New EU PV Regulations in Effect! Key compliance changes you need to know:
Mandatory risk-based audits covering all PV activities.
Stricter subcontractor oversight and contract requirements.
Streamlined PSMF documentation (now only for "major/critical" deviations).
Internal handling of signal detection (no more standalone submissions to EMA).
Updated PSURs (requiring RMM effectiveness data) & mandatory digital PASS registration.

🇮🇳 🇬🇧 🇺🇸 Regional Alerts (India, UK, US)

India: New safety warnings mandated for Doxycycline (CNS side effects) and Carbimazole (blood disorders).
UK (MHRA): Dual-licensed medicines must align with the new EU PV standards. (Also: Precautionary recall for MOVICOL Ease Citrus Powder).
US (FDA): MedWatch issued safety/correction alerts for TRUE METRIX Blood Glucose Systems and Medline Homecare Beds.

🗓️ Mark Your Calendars!
Feb 23–24, 2026: 17th Global PV & Clinical Trials Summit (London).
Apr 28–29, 2026: 5th PV & Drug Safety Conference (Madrid).
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💡 The PV landscape is evolving rapidly — AI integration, stricter audits, global collaboration, and stronger post-marketing surveillance are reshaping compliance expectations worldwide.

Follow OshVi Solutions for weekly PV intelligence, regulatory insights & career-focused training updates.

Which of these regulatory updates will impact your daily PV operations the most? Let's discuss in the comments! 💬

16/02/2026

🚨 Regulatory Shift: The New EU Audit & Safety Mandates are Live (Feb 2026)

The landscape of Global Pharmacovigilance just got tighter. As of this week (Feb 16, 2026), we are seeing the full implementation of the new EU regulatory framework, and the impact on vendor oversight is immediate.

I’ve summarized the critical weekend updates in this video 🎥.

Key Watchouts for PV Leaders:

🔹 EU Audit Rules: It is no longer optional—all third-party vendors must agree to be audited. Sub-sub-contracting now requires your explicit written consent. Time to review those PV Agreements!

🔹 Safety Alerts: Significant restrictions announced for the Chikungunya vaccine (IXCHIQ) and new warnings for GLP-1 Agonists regarding NAION risks.

🔹 Recalls: Global supply chain alerts affecting Canada (packaging errors) and the USA (labeling compliance).

If you haven't updated your PSUR templates to include the new "RMM Effectiveness" data requirements, you are already behind schedule.

Please reach us at connect@oshvi.in

15/02/2026

Best wishes on Maha Sivarathri. మహా శివరాత్రి శుభాకాంక్షలు

13/02/2026

1. EMA Recommends Withdrawal of Levamisole Medicines
• EMA-PRAC recommended withdrawing all medicines containing levamisole from the EU market.
• This follows a safety review showing a serious side effect — leukoencephalopathy, a rare brain condition — can occur even after a single dose and is unpredictable in onset.

2. AI Is Strengthening Pharmacovigilance Processes
• Medical education session in Indore, India, highlighted how Artificial Intelligence (AI) is being used to improve pharmacovigilance outcomes in faster detection and analysis of adverse drug reactions (ADRs) as well as real-time reporting, which may enhance patient safety decision-making.
• This trend mirrors broader global adoption of advanced analytics and automated surveillance in PV activities

3. Upcoming Global Pharmacovigilance & Clinical Trials Summit
• A key Pharmacovigilance & Clinical Trials Summit is scheduled for 23–24 February 2026 in London, UK, focusing on:
o Risk-based monitoring
o Trial optimization
o Technological advancements in drug safety

4. India’s Contribution to Global Pharmacovigilance
• India has risen to 8th place globally in pharmacovigilance contributions to the WHO safety database — a major improvement from historic rankings.
• This reflects stronger adverse event reporting and regulatory vigilance.

contact@oshvi.in

08/02/2026

👉 If you’re looking for a trusted partner to strengthen your compliance framework, please reach us at contact@oshvi.in

03/02/2026

Feb 04 is World Cancer Day. Remember, regular check-ups are key for early detection and better prognosis. OshVi Solutions supports cancer awareness initiatives.