THOUGHT LEADERSHIP

Drug Safety & Pharmacovigilance professionals have long awaited consistency in the manner in which the US Food and Drug Administration (FDA) accepts Individual Case Safety Report (ICSR) submissions. For years, the industry has navigated different submission procedures for FDA compared with other regions, as well as differences between Investigational New Drug (IND) reporting and post-marketing pharmacovigilance reporting. The FDA has been working towards harmonization of ICSR submissions and the final guidance is here! FDA will require that both premarket and post-market safety reports be submitted electronically in the ICH E2B(R3) format, the format that is currently the standard in the EU. Let us explore the current FDA practices, the need for updated processes, timelines for implementation, and what pharmacovigilance professionals need to do to prepare for the change.

Current European law prohibits businesses from sending personal information about European citizens to companies in the United States (US) without specific contractual obligations to protect the privacy of the information.  However, the current Data Privacy Framework (DPF) allows US companies that are “Certified” under the Framework to import and process personal data of European citizens without these contractual requirements.

Pharmacovigilance is one of the most essential functions in the drug development process as it is vital for the continued safety evaluation of a product from the first time it is administered to a person through the post-marketing setting. A Pharmacovigilance program must be set up to detect, assess, understand and prevent adverse effects or other possible drug-related problems, and these activities require extensive documentation and monitoring. The global safety database is the primary tool to support Pharmacovigilance activities as it allows us to review safety cases across an entire investigational program rather than study-by-study. It is the Pharmacovigilance provider’s responsibility to ensure that the database is updated and maintained by inputting individual case safety reports (ICSRs) in a consistent, standardized, and timely manner.

Medidata NEXT is hosted each year by PROMETRIKA’s technology partner Medidata to help sponsors stay informed on products and solutions for managing clinical trial data. I had the privilege of attending this year’s event in New York City as a PROMETRIKA representative. This was my first-ever industry conference, and Medidata NEXT set the bar high. The venue was in Times Square, and, upon entering the hotel, we were greeted with warm hospitality and a HUGE Medidata NEXT banner. The first event was the introductory keynote, which started with an impactful story of a diabetic mom and her daughter. This introduction served to remind attendees why we do what we do - help people living with medical challenges. The session continued for 2 hours and described the future direction of the Medidata platform.

On the surface, a medical writer has a simple calling: communicate medical information and research results clearly to the intended audience. How one achieves this goal is what sets apart a great medical writer. Arriving at a high-quality final document requires planning, clear communication, coordination between team members, and building consensus among stakeholders. These are not directly related to writing per se but are central to the success of our projects, so how does a medical writer learn and hone such skills?