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September’s Regulatory Focus: Diversity in regulatory affairs, clinical trials, and more

Posted 07 October 2021 | By Renee Matthews  | ©

September’s Regulatory Focus: Diversity in regulatory affairs, clinical trials, and more

Feature articles during September focused on diversity in regulatory affairs, challenges in conducting medical device clinical trials in Europe, clinical trial regulation and laws in China, and risk management in working with third-party distributors.
 
Equity in action, diversity, and resilience
In Fall 2020, representatives from Pfizer Global Regulatory Affairs (GRA) and the Howard University College of Pharmacy (HUCOP) initiated discussions about creating a career pipeline for students at historically black colleges and universities who were interested in the regulatory profession. In Fostering diversity and talent: A Pfizer case study, Monique Carter and co-authors from Pfizer and HUCOP track efforts to devise and launch the Advanced Pharmacy Practice Experience program as part of HUCOP’s doctor of pharmacy curriculum. Students selected for the pilot program were integrated into the Pfizer GRA internal medicine and global regulatory groups, where mentors and preceptors offered guidance and information based on their real-world experiences as regulatory professionals. The students participated in regulatory activities; learned about regulatory postgraduate and career opportunities; and gained awareness of efforts to address unmet healthcare needs and improve patient outcomes. Next steps include expanding the program to other colleges and universities, assessing the feasibility of expanding globally, and creating additional postgrad opportunities, such as fellowships.
 
The nature of regulatory work is inherently stressful, putting regulatory professionals at risk for burnout, writes Phyllis Marquitz. In Strengthening the regulatory profession through resilience and diversity, Marquitz argues that building resilience into organizational design through diversity (in race, ethnicity, or sexual orientation, for example) can strengthen an organization and health of the profession. Put another away, individuals who bring variety through their diversity contribute to organizational resilience by contributing to a broader knowledge base. Regulatory professional organizations have created tools for cross-functional capability-building, such as the Regulatory Affairs Professionals Society’s Regulatory Competency Framework, which was updated in 2019 to include mechanisms for promoting resilience. Such models provide clarity about roles and accountability, communication, competencies, and the critical skill sets needed to sustain a resilient regulatory community.
 
Clinical trials and risk management
Most clinical trial sites, other than those related to COVID-19, have experienced delays during the pandemic and sometimes, a complete halt of operations. That disruption has affected clinical research outcomes and presented unexpected challenges to companies conducting the trials. In Challenges and opportunities in medical device clinical trials in Europe, Catherine Higginson, Veronika Schweighart, and Robert Radloff report on findings from a 2021 survey on where European medical device and pharmaceutical companies see the greatest challenges in clinical trials. Respondents’ top challenges included lack of personnel, time investments, complexity of the study protocol, the identification of suitable subjects, and data analysis and publication. The findings also suggest most participants have not yet conducted decentralized clinical trials, which have gained traction during the pandemic, although more than two-thirds said they planned to use them in coming years.
 
In China’s data localization‒centric policies and their impact on human research, Balaji Venkatnarayanan reviews Chinese laws and regulations governing healthcare data and genomic resources during the last 2 decades and their impact on clinical research in humans. The analysis addresses requirements for the collection, analysis, storing, and sharing of data, including real-world data; ethics and informed consent; and data privacy and localization. The author advises companies conducting research to be vigilant about complying with the complex requirements, especially in regard to localization and cross-border transfer and identifying potential risks and mitigation strategies for compliance.
 
Medical device and in vitro diagnostic (IVD) companies entering the global healthcare distribution market need to carefully weigh their options when deciding between using direct or third-party distribution channels. In Strategies for managing regulatory risk with third-party distributors, Maham Ansari suggests manufacturers create and implement a rigorous internal process for distribution qualification and selection. Understanding the local market, healthcare system, regulatory landscape, and international product distribution process are all crucial to setting up a flexible, customized approach to distribution that minimizes regulatory risk and maximizes the prospects of commercial success.
 
Upcoming in Regulatory Focus
What’s coming in October?
Articles during October will examine Vaccines, Advanced Therapies, and Biologics. Look for this topic and more throughout October at Regulatory Focus.
 
And November?
For the November issue, Regulatory Focus will examine Global development for pediatric products. The submission due date for articles has been extended to 25 October 2021. To contribute, email rmatthews@raps.org.
 
Call for articles
December issue
In December, Regulatory Focus will cover APL and the role of social media. The submission due date for articles is 1 November 2021. To contribute, email rmatthews@raps.org.
 
Upcoming in RF Quarterly
Regulatory Focus launched RF Quarterly in 2021. Each issue of RF Quarterly is comprised of original content, developed around a theme, as a member-exclusive benefit.
 
The latest issue, focusing on quality and compliance, is now available. Topics through 2022 will be:
 
  • RAPS 2021 Convergence (December 2021)
  • Software as a medical device (March 2022)
  • Regulatory history (June 2022)
  • Strategy in regulatory affairs (September 2022)
  • RAPS 2021 Convergence (December 2022)
 
Previous issues of RF Quarterly  
To contribute to the upcoming issuesemail rmatthews@raps.org.
 
For more information about monthly articles and RF Quarterly, see Guidelines for Authors and the 2021 Editorial Calendar and 2022 Editorial Calendar.

 

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