New Pharmaceutical Safety Regulations - Expedited Reporting & Argus Updates: Webinar Series

Pharmacovigilance Reporting Obligations can be divided into two buckets: Expedited and Periodic Reporting. While Periodic Reporting has been surprisingly stable since the global introduction of the Development Safety Update Report (DSUR) and the Periodic Benefit Risk Evaluation Report (PBRER) in 2011, Expedited Reporting of Individual Case Safety Reports (ICSR) has undergone a continual transformation following the introduction of the E2B XML file in 1995 and the major update to E2B R3 in 2012. Now, we are confronted with the issue of regulators requiring submissions that need different E2BR formats.

This session will examine the current pharmaceutical regulatory landscape and provide guidance on how to stay compliant in this fast-changing environment. Experts will give insights on:

• What new pharmacovigilance regulations you should be keeping an eye on
• The major elements of the product harmonization initiative IDMP and what they mean for compliance
• How the evolution of codelist harmonization impacts Medical Device Reporting
• What is in store for Pharmaceutical Vigilance Obligations

Meet the Speaker

Uwe P. Trinks Ph.D.

Practice Leader, Pharmacovigilance Technologies, IQVIA

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To keep up with the ever-changing pharmaceutical regulatory environment, companies are constantly upgrading their safety systems. Is the latest release of Argus worth an upgrade or can you afford to wait for the next one? This session will examine the various considerations that companies should have when upgrading their pharmaceutical safety system or contemplating switching to a new one. With the release of the most recent version of Argus, it poses the question of what this industry could be improving on and taking advantage of when it comes to drug safety technology. Experts will discuss:

• The current pharmaceutical regulatory landscape and to what degree the latest Argus version supports it
• Whether the out-of-the-box functions of Argus 8.4 and 8.4.1 meet business’ needs or require additional configuration or customization
• What features can be expected in future releases of pharmaceutical safety systems, specifically Argus 8.4.2

Meet the Speaker

Axel Hagel

Practice Leader, PV & RM Services, IQVIA

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