The pandemic has only heightened the focus on patient safety as companies across the world accelerate their timelines in the race to develop preventive and therapeutic agents against COVID-19.
By Sanjay Vyas
Ensuring patient safety is paramount in the development of new drugs, and pharmacovigilance (PVG) plays an indispensable role in this critical endeavor. The pandemic has only heightened the focus on patient safety as companies across the world accelerate their timelines in the race to develop preventive and therapeutic agents against COVID-19. The vast scale of vaccination programs that are likely to result from these efforts will necessitate a highly orchestrated approach to monitoring and reporting all adverse events quickly, efficiently and in real time to
inform clinical practice. Moreover, the rapid shift to decentralized clinical trials has necessitated a much greater reliance on technologies to enable telemedicine, wearable devices, patient- reported outcomes and more, with a corresponding shift in how patient safety information is collected, managed and reported.
To keep the pace with pandemic challenges as well as rapidly evolving global regulatory guidelines, pharmacovigilance training courses are increasingly seen as an essential tool in maintaining a strong, well-trained cadre of PVG professionals and equipping organizations with the knowledge and expertise needed to design and execute robust PVG systems. PVG training curricula should include both theoretical and practical learning about the real-world applications of PVG and the optimal use of technology to enable seamless collaboration across
different geographic locations.
In American and European institutions, PVG training programs have well-defined course modules, including eTMF for clinical trial management, project management and literature Reviews, coupled with practical internships at biopharmaceutical and clinical research organizations that offer flexible schedules to meet the needs of working professionals.
In India, pharmacovigilance courses are increasingly being offered to strengthen the country’s PVG oversight and ensure that patient safety remains at the heart of the Indian pharmaceutical environment. While India continues to be a preferred outsourcing hub for PV activities, many of India’s clinical research courses do not offer the option to specialize in PVG, and their internship trainings provide little to no hands-on work experience.
Parexel Academy Trains the Workforce of the Future
At Parexel Academy, our courses include academic and theoretical learnings combined with practical training in the tactical aspects of clinical research with a strong focus on PVG—exposure that can only be acquired through a global company with deep and broad PVG experience navigating real-world challenges. All Parexel Academy courses are taught by renowned experts with global experience and deep therapeutic expertise. Courses are interactive, engaging and provide direct interaction with experienced professionals who act as trainers in parallel to their respective positions in the industry.
Parexel Academy offers training in EMEA, Americas and APAC, with postgraduate programs for clinical research professionals and individuals who are transitioning to a career in a clinical research. The Academy has well established partnerships with universities in Germany, Singapore, Japan and the U.S. for both undergraduate and postgraduate trainings.
In India, Parexel Academy’s collaboration with Chitkara University provides a comprehensive master’s program that combines theoretical education in clinical research with contextualized learnings through practice labs, with a specialty PVG focus. Student internships across various clinical research related functions will further enhance their exposure to clinical research and PVG skills while introducing students to a strong network of contacts across the clinical research industry to enhance career placement opportunities.
Parexel Academy programs include country-specific certification and trainings for clinical site staff and investigators as well as qualification and training for pharmaceutical companies and clinical research providers. Because Parexel’s experts not only oversee their respective regions but manage global clinical trials and related projects, they are able to provide a comprehensive view of PVG and demonstrate its real-world applications in the marketplace.
Furthermore, the pandemic has provided a prime opportunity to introduce students to decentralized clinical trial approaches. Parexel’s experience in seamlessly transitioning to decentralized, patient-centric techniques such as telemedicine, wearable devices, remote monitoring and patient-reported outcomes makes Parexel Academy uniquely positioned to train professional on how to adopt these techniques in today’s environment.
(The author is Senior Vice President, India Country Head & Head CTS&L, Parexel International. Views expressed are personal.)