April’s Regulatory Focus: Specialist vs. generalist, RI, and more

Feature ArticlesFeature Articles | 06 May 2022 | Citation

Feature articles during April examined the roles of the regulatory specialist and generalist and the application of regulatory intelligence (RI) in managing the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), developing an in-house regulatory database in the oncology setting, and strategic planning. Also included are articles on expedited regulatory pathway options, selecting control groups in pediatric clinical trials, and the role of artificial intelligence (AI) in regulatory practice.
Keywords – career planning, generalist, pediatric clinical trials, regulatory intelligence, specialist
Specialist vs. generalist
There is much debate among regulatory professionals about the merits of building a generalist versus specialist skills set. In Regulatory specialist, generalist, or generalized specialist: Weighing the options, Rupali Gupta, George Cusatis, and Darin Oppenheimer describe the respective roles and the challenges in deciding between them during the course of one’s career. The choice is seldom linear – career planning is fluid and changes constantly – but the authors provide a useful step-by-step guide that factors in specialist-generalist considerations when charting out a career trajectory.
Regulatory intelligence
A key mission of RI is to proactively identify regulatory changes and assess their impact on business. This ability to anticipate, prepare, and rapidly respond in a challenging environment is crucial for the industry as its faces future challenges and health threats. In Managing the challenges of the new IVDR: Lessons from the pandemic, Raquel Carnero Gómez, details how RI can help medtech companies assess the impact of the EU IVDR. The author looks at how regulatory intelligence helped device manufacturers manage the changes in regulations during the pandemic and how the lessons learned can support the industry in assessing and planning for the impact of the new legislative framework.
In In-house regulatory database development: Solution for a competitive oncology landscape, Andrew Leung provides an overview of such development, with specific reference to the rapidly expanding oncology treatment setting. A purposeful, interactive interface allows users within regulatory affairs to access targeted content related to various oncology product programs. Moreover, in-house development means there are ample opportunities for direct feedback or suggestions to update or hone the system to best suit evolving organizational needs.
In Strategic applications of regulatory intelligence, Sapna Ghelani, Hemang Kotecha, George Cusatis, and Darin Oppenheimer describe a three-part process of RI (data input, analysis, and output) and its strategic application for achieving continued business success across the product life cycle. The authors tease out the various aspects the RI applications and provide useful guidance on each, including due diligence, strategy, and policy as well as product planning and development and sustenance and postmarket surveillance.
Pathways, pediatric trials, and AI
Expedited regulatory programs recognize the need for products targeting serious illnesses with unmet clinical need, such as COVID-19, to reach the market as quickly as possible and without the depth of evidence required for regular authorization. In Expedited regulatory pathway options and utility: Pandemic to endemic, Sarah A. Robinson, Alison R. Carter, and David A. Brindley compare existing expedited pathways in the US and EU and discuss COVID-specific regulatory programs that have been created in the past 2 years. They examine whether the emerging regulatory lessons around COVID-19 products can be used to support drug development in the persisting endemic and/or the long-term development of non-COVID therapeutics.
In Considerations for selecting control groups in pediatric clinical trials, Josephine Dewhurst looks at different types of control groups and the specific challenges in designing pediatric trials. Selection of the most suitable control arm can be key to ensuring a successful trial because it can affect participant enrollment and retention, both of which are a challenge in pediatric trials because the population is small. Patient number, disease severity and progression, ethical use of placebo, use of off-label care and active controls, and availability of representative real-world data are among the considerations Dewhurst recommends for ensuring a feasible trial design.
As demand increases for accuracy and quick turnaround in regulatory tasks, the technology is evolving to meet these new needs, especially through the integration and real-world application of AI. In Artificial intelligence in regulatory practice, Zehra Mazhari examines how the regulatory profession can draw on AI and machine learning to navigate the complexities and fluidity of the global regulatory landscape.
Citation Matthews R. April’s Regulatory Focus: Specialist vs. generalist, RI, and more. Regulatory Affairs. 6 May 2022. https://bit.ly/3kTLHwF
Upcoming in Regulatory Focus
What’s coming in May?
Articles during May will provide an update on the EU IVDR and MDR. Look for this topic and more throughout May at Regulatory Focus. The submission due date for articles has been extended to 16 May 2022.
And June?
For the June issue, the topic will be Nutrition in health and disease management and the gut microbiome.
Call for articles
July issue
The topic for July will be Mentorship in regulatory affairs. The submission due date for articles is 1 June 2022.
August issue
CMC [chemistry, manufacturing, and controls] regulatory issues is the topic for the August issue. The submission date for articles is 1 July 2022.
To contribute, email rmatthews@raps.org                Also see 2022 Editorial Calendar
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Topics through 2022 will be:
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