RF Quarterly, December 2021: Key takeaways from RAPS Convergence 2021

RF QuarterlyFeature ArticlesFeature Articles | 13 December 2021 | Citation  |  PDF Link PDF

Welcome to the December issue of RF Quarterly which focuses on key takeaways from RAPS Convergence 2021, including patient-focused approaches in regulatory decision making and drug development, the transition from convergence to harmonization for global pharmaceutical regulatory requirements, pediatric drug development, and regulatory and clinical strategies.


Patient perspective and global harmonization
There is increasing recognition of the importance of patients’ unique, experience-based perspective on living with a chronic condition and incorporating that perspective into drug development and clinical trials. In Patient-reported outcomes and patient preference information in regulatory decision making, Richard Jahn and colleagues discuss the patient-focused trends in collecting patient experience data (PED), such as patient-reported outcomes (PROs) and patient preference information (PPI). They cover patient-focused programs initiated by the US Food and Drug Administration and European Medicines Agency and discuss how agencies and sponsors can collaborate to elevate the role of PROs and PPI. That collaboration and use of regulatory guidance are critical in ensuring PED collection methods and analyses are fit for their intended purpose and yield high-quality data to reliably inform regulatory reviews. Global acceptance and harmonization of PED collection and analysis methodology will be an important step toward efficient application of these patient-focused principles to global drug development.
Implementation of International Council for Harmonisation (ICH) guidelines is critical for achieving global regulatory harmonization. As important, is industry participation in future implementation surveys across all ICH regions for monitoring the adequacy of implementation and adherence to ICH guidelines among regulatory authorities. In ICH implementation: The transition from convergence to harmonization, Stewart and colleagues outline the roles of the ICH and World Health Organization in implementing ICH guidances and address ongoing harmonization initiatives. Although there is strong evidence of adequate implementation and general adherence to the guidelines, convergence and harmonization remain a work in progress and require a shared commitment between regulatory authorities and companies in the push toward greater global harmonization.
Pediatric drug development and strategizing
Pharmaceutical product development in pediatrics is challenging and close coordination along the regulatory pathway, starting with early engagement with regulators, is essential to bringing a safe and efficacious product to market. In Pediatric drug development: Increasing success and overcoming obstacles, Linda McBride and colleagues discuss pediatric drug development in the EU and US, with a focus on overcoming regulatory obstacles. They present the commonalities and differences between US and EU regulations and guidelines and emphasize the importance of understanding the regulatory risks and benefits along the regulatory pathway. It is also crucial to identify the common pitfalls and obstacles that could threaten the success of a development program. The landscape of pediatric drug development is subject to precedent, so it is advisable to stay current on EU and US regulatory requirements and recent approvals, especially when conducting clinical trials.
A comprehensive regulatory strategy, taking into account performance and preclinical testing and clinical evidence, is essential for evaluating a novel medical device for marketing.In Regulatory strategy and clinical strategy: Where do they converge and diverge?, Angela Mallery and Pamela Wolfe explain how regulatory and clinical strategies converge and diverge while emphasizing they are interconnected rather than mutually exclusive. The authors offer guidance on evaluating regulatory environments and requirements when developing a regulatory strategic pathway to approval and addressing pertinent questions when developing a clinical strategy. Strategy development should be a collaborative process, starting with defining countries of interest, submission type, indication for use, and device classification. That information, as well as that from predicates and other evidence generated on the specific device, can be used to develop a clinical strategy for providing human safety and performance evidence to support a regulatory submission for device marketing.
As always, I thank the authors for their generosity in sharing their knowledge and expertise with the RAPS regulatory community and hope their articles and will serve as useful guidance and resources in your work.

Renée Matthews, Senior Editor, is responsible for RF Quarterly and Regulatory Focus Features. She can be reached at rmatthews@raps.org

Acknowledgment I also thank the following colleagues: freelance writer Randolph Fillmore; art director Simon Fong; Tricia Young, RAPS director of meetings and educational experiences; Denise Fulton, for editorial guidance and support; Amy Fisher and the marketing team; and Ravi Gaddipati for production and web support.

Citation Matthews R. Introduction: 2021 Convergence. RF Quarterly. 2021;1(4):1-2. Published online 13 December 2021. https://www.raps.org/news-and-articles/news-articles/2021/12/rf-quarterly-december-2021-key-takeaways-from-raps

About RF Quarterly
Regulatory Focus launched RF Quarterly in mid-March. Each issue of RF Quarterly is comprised of original content, developed around a theme, as a member-exclusive benefit.

Upcoming in RF Quarterly
  • Software as a medical device (March 2022)
  • Regulatory history (June 2022)
  • Strategy in regulatory affairs (September 2022)
  • Artificial intelligence (December 2022)

Current issue RF Quarterly 
Previous issues  
To contribute to upcoming issues, email rmatthews@raps.org
For more information, see Guidelines for Authors and the 2022 Editorial Calendar.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you