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The Current Landscape of Drug Safety and Pharmacovigilance Certifications

November 2021

The Current Landscape of Drug Safety and Pharmacovigilance Certifications

On January 29, 1849, a young woman in the north of England named Hannah died two minutes into a surgical procedure to remove an infected toenail.1 Hannah had received chloroform, which at the time was a new and powerful anesthetic and was thought to be safe.1 In the years that followed, other cases of death due to chloroform use prompted The Lancet to publish a report on these happenings, which became the first published case of an adverse event.1 In the 170 years that followed, pharmacovigilance evolved from the retroactive practice documenting adverse events to a proactive system which stratifies risk and now sits at the crossroads of regulatory affairs, information technology, clinical medicine, and drug development. Now, after the COVID-19 pandemic saw the rapid commercialization and deployment of first-in-class mRNA vaccines, there is a larger spotlight on the utility of drug safety and the people that make it happen more than ever before.

Training for pharmacovigilance professionals has changed dramatically over the past 20 years. Traditional curricula in medical, public health, and pharmacy schools do not emphasize drug safety and pharmacovigilance.2 Prior to the 2000’s, drug safety physicians predominantly received on the job training, with a minority of professionals being educated in quality assurance or regulatory affairs.3 However, over the course of the past 6 years, university programs, online classes, and certification programs have grown considerably.3 The Uppsala Monitoring Centre, the Drug Information Association, the European Consortium on Pharmacovigilance, American Society of Pharmacovigilance, the Certified Clinical Research Professional Society, and many more have created accredited certification programs encompassing everything from Argus database use to medical monitoring.3 Additionally, the heterogeneity of curriculum topics, content accuracy, and up-to-date content piqued the interest of the International Society of Pharmacovigilance (ISoP), in 2015.4 ISoP subsequently created a scientific advisory board to unify pharmacovigilance education and add measurable legitimacy to professional certifications.4 In 2021, the Institute of Pharmacovigilance, led by ISoP board members, created the Global Professional Pharmacovigilance Certification (GPPC), a three-stage examination sequence which has different exams for entry-level, mid-career, and senior pharmacovigilance professionals, which will be open to applicants in December 2021.4 What makes the GPPC different is that it not only creates an internationally recognized standard for the knowledge and skills required to work in drug safety, but it also incorporates peer-reviewed periodic updates to provide professionals with current information and guidelines.

While no certification program can compare to years of industry experience, the willingness and ability of professionals to engage in learning can have a transformative organizational impact. Human capital requires investment in learning and development to appreciate at scale. Knowledge becomes outdated, details can be forgotten, and new industry best practices may be overlooked. While it is impossible to quantitatively assess the ability of any one individual employee to make a meaningful organizational impact, the critical thinking, problem solving, and soft skills required to complete challenging post-graduate certifications undoubtedly foster the skills needed to do just that.

Nowhere is the importance of continued education and certification more important than in the changing landscape of pharmacovigilance. Gene therapy medicines, which are currently under investigation for autoimmune conditions, heart disease, cancer, and HIV, have the novel capacity to permanently alter downstream signaling pathways from DNA to RNA and ultimately proteins, but may take up to 15 years for adverse events to manifest.2 Similarly, chimeric antigen receptor T-cell therapies, first approved for the treatment of B-cell lymphomas in 2017 with Axicabtagene, require special risk evaluation and mitigation strategies for drug safety to detect long-term adverse events.2 Combination medical devices which incorporate investigational agents into an implanted device are also being developed and require a keen understanding of safety and safety regulations for both medical devices and drugs. Recent integration of artificial intelligence within pharmacovigilance operations for many companies adds to the complexity of these changes (See "The Emergence of Artificial Intelligence/Machine Learning Tools to Enhance Risk Management in Clinical Trials"). With the rapid pace of these regulatory developments and new technologies, it is quickly becoming a requirement that pharmacovigilance professionals actively engage in ongoing professional development and training.

Most pharmacovigilance practices are guided by local and regional healthcare systems and regulations. Few organizations venture to stretch their scope of impact beyond that, as operational tasks of timely collection, assessment, monitoring, and reporting of safety data tend to saturate the capacity of safety teams. At TRI, our drug safety and pharmacovigilance specialists have either recent industry experience, university degrees, or professional certifications specific to up-to-date drug safety knowledge and skills. In addition, TRI provides robust on the job training and apprenticeship to sustain and develop a nimble workforce ready for the changing drug safety landscape of tomorrow.


About the Author

Pinak Joshi, MD is a safety and pharmacovigilance specialist. He earned an MD from St. George’s University and MBA from Quantic School of Business and Technology.



Footnotes

  1. Fornasier G, Francescon S, Leone R, Baldo P. An historical overview over Pharmacovigilance. Int J Clin Pharm. 2018 Aug;40(4):744-747. doi: 10.1007/s11096-018-0657-1. Epub 2018 Jun 15. PMID: 29948743; PMCID: PMC6132952.

  2. Kugener et al 2021:
    https://link.springer.com/article/10.1007%2Fs40264-021-01078-8

  3. Cobert, B. (2015, August 14). Update on Drug Safety Courses & Certificates. Retrieved from
    https://www.c3isolutions.com/blog/update-on-drug-safety-courses-certificates/?cn-reloaded=1

  4. Institute of Pharmacovigilance. (n.d.). 2021. Retrieved from
    https://pharmacovigilance.institute/







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