Thought Leadership

User Requirements for AI in GxP: AI/ML Software with Confidence

James Mecksroth — Mon, 23 Feb 2026 12:00:00 GMT

Artificial Intelligence and Machine Learning are rapidly moving from "innovation pilots" to everyday tools in regulated life sciences organizations, supporting everything from deviation trending and complaint analysis to document drafting, image recognition, and clinical insights.

Why Medical Information Is Central to MAH Compliance, Access, and Patient Safety – Identifying Reportable Information

Hannah Hunter — Thu, 19 Feb 2026 12:00:00 GMT

Inquirers rarely contact Medical Information (MI) to report an adverse event (AE), special situation event (SSE), or product quality complaint(PQC). They call because they have a question, but collecting this data is imperative for Marketing Authorization Holders (MAHs). While obvious AEs, such as "I used your medicine and experienced a headache" are straightforward to recognise and capture, other situations are far more nuanced. Special situations, unexpected benefits, and product complaints can be difficult for patients and even healthcare professionals (HCPs) to identify as reportable.

Why Clients Are Centralizing Medical Information Functions

ProPharma Staff — Thu, 12 Feb 2026 12:00:00 GMT

Why Consistency in Medical Information Matters

A doctor in Germany and a doctor in Canada ask the same question about the safety and effectiveness of a medication. They should receive the same high-quality response — clear, comprehensive, and clinically useful — regardless of where they’re based.

AI in PV Surveillance: Aligning Innovation with Regulatory Expectations

James Mecksroth — Mon, 02 Feb 2026 12:00:04 GMT

Artificial Intelligence (AI) is moving quickly from pilot projects into routine pharmacovigilance (PV) operations. The 2025 CIOMS Working Group XIV report on AI in pharmacovigilance provides a timely, practical foundation for firms looking to use AI responsibly, especially across case intake and processing, signal activities, and literature surveillance.

Preparing for eCTD 4.0: What FDA Submitters Need to Know

Jason Cober — Thu, 29 Jan 2026 16:45:52 GMT

Why Early Planning Matters for Regulatory Operations

While it's only been a handful of years since eCTD Version 3.2.2 became the standard submission format for all major components of US regulatory applications, changes are on the horizon for eCTD. In September 2024, FDA announced support for eCTD Version 4.0. While the Agency is currently accepting new regulatory applications in eCTD 4.0 on a voluntary basis and does not yet support forward compatibility for applications submitted in prior versions of the eCTD format, we’re only a few years away from eCTD 4.0 becoming the industry standard. Prior experience with eCTD transitions tells us that the runway ahead of us will pass quickly and eCTD 4.0 will be here before we know it. Now is the time to plan and strategize your organization’s transition and ProPharma has added expertise and resources to help prepare your operations for the implementation of eCTD 4.0.

Elevating Laboratory Compliance in 2026: GLP, Outsourcing, and QA

James Mecksroth — Mon, 26 Jan 2026 12:00:01 GMT

In today's complex life sciences ecosystems, pharmaceutical and biologics companies face unprecedented demands to deliver safe, effective therapies while navigating a global regulatory environment more intricate than ever. At the heart of this challenge is one core fact: Data integrity and compliance in laboratory settings matter.

2025 FDA Promotion Enforcement: What Pharma Must Know for 2026

ProPharma Staff — Wed, 14 Jan 2026 21:03:43 GMT

2025 was a year of significant regulatory disruption. One that will have lasting implications for how pharmaceutical companies approach advertising and promotion in 2026. From an unprecedented surge in FDA enforcement activity to leadership turnover within the Office of Prescription Drug Promotion (OPDP) and growing uncertainty around long-standing draft guidances, the compliance landscape is shifting quickly.

Understanding FDA Requirements for Medical Information Services in the US

Dave Bezick — Mon, 22 Dec 2025 12:00:00 GMT

In the highly regulated industry environment, medical information (MI) services are far more than a support function, providing information to patients, caregivers, and Healthcare Professionals; they’re a cornerstone of compliance. The Food and Drug Administration (FDA) sets clear expectations for how MI should be managed, communicated, and documented (FDA, 2023a).

Annex 11 2011 Version vs. Annex 11 2025 Draft Version

ProPharma Staff — Mon, 15 Dec 2025 12:00:00 GMT

The GMP/GDP Inspectors Working Group and the PIC/S Committee jointly recommended that the current version of Annex 11 on Computerised Systems be revised to reflect changes in regulatory and manufacturing environments. The revised guideline should clarify requirements and expectations from regulatory authorities, and remove ambiguity and inconsistencies

Rescuing a Struggling PV Program: Warning Signs, Root Causes, and What to Do Next

Laura Hopper — Thu, 20 Nov 2025 12:00:00 GMT

Living near the ocean growing up, I have been warned countless times that by the time you realize you are in a riptide, you may already need to be rescued. You'll know things aren't going quite right, that you have to work awfully hard just to stay in the same place, and that no one is responding to your cries for help, but you don't realize how deeply in trouble you are, until it's too late. This same advice may also apply to working with subpar pharmacovigilance (PV) vendors. When clients realize that their PV activities are not running smoothly, that they are doing the heavy-lifting and not making any progress, while their requests are not being responded to, perhaps the situation requires a full-blown rescue.