Pharma R&D Today
Ideas and Insight supporting all stages of Drug Discovery & Development
Debates on Pharmacovigilance – What’s new and trending
Posted on March 2nd, 2017 by Xuanyan Xu in Pharmacovigilance
Fleming’s Pharmacovigilance & Risk Management Strategies Forum is always an excellently organized event, attended by industry leaders, policy makers and legislators. It’s a superb opportunity to meet colleagues, make new connections, and discuss the challenges of PV and risk management in day-to-day operations across all departments. Expert discussions on what’s new and trending are the core of the event!
This year’s two-and-half-day event was held in Amsterdam. The agenda covered many interesting and important topics for PV teams, including:
- Patient centricity in pharmacovigilance
- Regulatory harmonization and its impact
- Integrating PV functions during divestment and acquisitions
- Social media monitoring for adverse events
Considerable discussion focused on the recent regulatory update and how industry experts are coping with it in their daily operations. There were also great opportunities to share experiences with PV problem solving and best practices.
In her talk “Getting ready for a PV inspection”, Sabine Jeck-Thole, the EU QPPV and Head of Regional Pharmacovigilance at Boehringer Ingelheim, shared best practices in the all-important preparation for regulatory inspections. For instance, when the announcement arrives, what should be done immediately? What documents should be prepared? And how should we prepare the talk about processes for ICSR handling, literature screening and communication with vendors and partners?
Compliance regulation is becoming stricter, so the PV experts in the audience found it one of the most important talks. Many agreed that their teams should spend more time assessing the effectiveness of their risk minimization measurement, signal management and post-authorization safety and efficacy studies in preparation for the coming regulatory inspections.
Does that mean that literature screening is no longer that important during an inspection? This notion was challenged by Dr. Joyce de Langen, Senior Product Solution Manager at Elsevier and PV expert with over a decade’s experience in the field. In her talk “Challenges and solutions in medical literature monitoring”, she shared her view on the role of scientific literature in pharmacovigilance, making it clear that:
- Scientific and medical literature is a relevant and high-quality source of safety information
- Systematic reviews of that literature is essential for aggregated reporting, signal detection and assessment of validated signals
Her talk inspired a lively debate around the role of literature and the daily challenges in screening for pharmacovigilance. Many agreed that when it comes to literature apart from dealing with the various regulatory requirements, building a balanced search strategy and having an oversight about vendor and partner activities are two of the biggest challenges in their day-to-day operations.
It was a valuable two-and-a-half days, full of fascinating discussions. We’re certainly all looking forward to next year’s event!
What are your biggest challenges with literature screening? How are you dealing with them? In our next webinar, PV expert Dr. Joyce de Langen will focus on literature management in pharmacovigilance and share her thoughts on the benefits and risks of outsourcing literature management.
Register for the webinar here!
All opinions shared in this post are the author’s own.
R&D Solutions for Pharma & Life SciencesWe're happy to discuss your needs and show you how Elsevier's Solution can help.
Solution Marketing Manager at Elsevier
- Why a reliable FAERS searching capability is essential for pharma companies
- Big Data and Proactive Pharmacovigilance
- The Challenges of Signal Detection in Spontaneous Reporting
- Taking a Balanced Approach to Monitoring Literature
- FDA Speeds Up Generic Approval Process