The RegIntelHub Weekly Global PV updates, distilled - powered by our community Two countries rewrote their PV rules this week. One has a 30-day deadline attached. Read the Algeria item before anything else. Thank you to everyone who shared links, documents, and local insights by email or in Slack - this newsletter exists because of you ๐ ๐ Start with the 10-Second Summary, then dive deeper if something touches your portfolio. โฑ๏ธ 10-Second Summary (Read This First) If you read nothing else...
2 months agoย โขย 2 min read
The RegIntelHub Weekly Global PV updates, distilled - powered by our community This week the FDA quietly made FAERS obsolete. If your signal detection workflows still point to legacy databases, now is the time to look up. Thank you to everyone who shared links, documents, and local insights by email or in Slack - this newsletter exists because of you ๐ ๐ Start with the 10-Second Summary, then dive deeper if something touches your portfolio. โฑ๏ธ 10-Second Summary (Read This First) If you read...
3 months agoย โขย 2 min read
The RegIntelHub Weekly Global PV updates, distilled - powered by our community This week is centred around ICH E2D(R1) โ the long-awaited update on post-approval safety data management. The revision clarifies how modern safety data sources (social media, patient support programs, market research, etc.) should be handled in pharmacovigilance systems. It will soon start affecting operational PV processes in the EU. As always, thank you to everyone who shared links, documents, and local insights...
3 months agoย โขย 2 min read
The RegIntelHub Weekly Global PV updates, distilled - powered by our community This week leans technical. Electronic reporting, DSUR expectations, RMP obligations, terminology standards, and MedDRA updates. If you work in operations, safety systems, or global oversight โ read carefully. As always, thank you to everyone who shared links, documents, and local insights by email or in Slack - this newsletter exists because of you ๐ ๐ Start with the 10-Second Summary, then dive deeper if something...
3 months agoย โขย 2 min read
The RegIntelHub Weekly Global PV updates, distilled - powered by our community A lighter week โ mostly clarifications and alignment updates. Nothing dramatic. But each item affects how you justify your setup during inspections. As always, thank you to everyone who shared links, documents, and local insights by email or in Slack - this newsletter exists because of you ๐ ๐ Start with the 10-Second Summary, then dive deeper if something touches your portfolio. โฑ๏ธ 10-Second Summary (Read This...
3 months agoย โขย 2 min read
The RegIntelHub Weekly Global PV updates, distilled - powered by our community A quieter week on the surface - but not insignificant. The EU PV landscape is as vibrant as ever, so make sure you read this issue to stay aligned with changes unfolding over the next few years. As always, thank you to everyone who shared links, documents, and local insights by email or in Slack - this newsletter exists because of you ๐ ๐ Start with the 10-Second Summary, then dive deeper if something touches your...
3 months agoย โขย 2 min read
The RegIntelHub Weekly Global PV updates, distilled - powered by our community This weekโs updates are a good reminder that regulatory change isnโt always loud โ sometimes itโs subtle alignment shifts, scope clarifications, or โnothing new, but now written downโ. Several of these updates wonโt require immediate SOP rewrites, but they absolutely affect how you justify your current setup during audits, inspections, and internal reviews. As always, thank you to everyone who shared links,...
4 months agoย โขย 3 min read
The RegIntelHub Weekly Global PV updates, distilled - powered by our community Hi, Quick catch-up on what moved this week โ and, more importantly, what it means for you in practice. As always, thank you to everyone who shared links, documents, and local insights by email or in Slack . This newsletter exists because you surface whatโs changing before it becomes a surprise. ๐ Start with the 10-Second Summary below, then dive deeper into the details if something affects your work. โฑ๏ธ 10-Second...
4 months agoย โขย 3 min read
The RegIntelHub Weekly Global PV updates, distilled - powered by our community Weโre back from the winter break, and this issue is packed with regulatory updates covering the period from mid-December to now. Many of these changes replace older rules, update reporting timelines, or introduce new frameworks โ so this one is worth bookmarking. A big thank you to everyone who contributed by email or in Slack ๐This newsletter exists because you share what you see on the ground. ๐ Start with the...
4 months agoย โขย 3 min read