2021 Editorial Calendar – RAPS Regulatory Focus

Last Updated 22 December 2020


Topic: Facing the New Normal: Impact of Disruptions on the Global Regulatory Community

Lead: Mary Speagle, RAC
Description: Impact of disruptions, such as COVID-19, on global RA: best practices for meeting remotely with health authorities; comparison of onsite and virtual GMPs; keeping clinical trials on track; working within your company vs with outsiders; third party reviews; monitoring quality and compliance. New implications for work style; remote/smart working; communication; developing the next generation of staff; finding new employment during COVID.
Articles due by: 8 January 2020
Publication: Through January 2021


Topic: Global Regulatory Harmonization

Lead: Orin Chisholm, GCULT, PhD, SFHEA
Description: Harmonization, convergence and reliance are becoming increasingly important in regulatory affairs. As molecules become more complex, the boundaries between different types of therapeutic products blur and national regulatory authorities (NRA) are stretched with the necessary expertise to review all these new product innovations. One response by NRAs is to develop work-sharing arrangements and some of these initiatives will be covered in this topic. However, work-sharing cannot occur without international adoption of technical standards, so we will also examine the progress occurring in this area, particularly with respect to adoption of ICH standards globally.
Articles due by: 15 January 2021
Publication: Throughout February 2021

MARCH 2021

Topic: Regulatory Intelligence

Leads: Linda Bowen, MSc, RAC, FRAPS, and William Sietsema, PhD
Description: This issue will include an overview of RI, including best practices; communicating in RI; regulatory precedence; sources of RI (toolbox, incl. precedence, FOI); profiling regulator staff and committee members; surveillance and monitoring techniques, RI metrics; RI skill sets; building an RI department; home grown and subscription RI databases; the future of regulatory intelligence.
Articles due by: 1 February
Publication: Throughout March


Topic: Global Clinical Trials

Lead: Editorial Advisory Committee  
Description: Articles will include experience with the EU voluntary harmonization procedure; implementation of the FDA guidance on patient-focused clinical development; ensuring diversity in clinical trials; real-world data and evidence, getting alignment of FDA, EMA, and PMDA on global registration trials; reporting clinical trial changes to the FDA during the COVID-19 pandemic; approaches to first in human trials for rare/ultrarare diseases (especially with gene or cell therapy).
Articles due by: 1 February
Publication: Throughout March

APRIL 2021

Topic: Regulatory Career Development

Leads: David Husman, PhD, RAC, and Peter A. Takes PhD, RAC, FRAPS
Description: The issue will examine what it means to work in a regulated environment; pathways to regulatory affairs (college; new hire; transition from other departments); credentialing; specializing in regulatory affairs (submissions; clinical; commercial; labeling; compliance); working at small vs large companies; consultancy; transitioning from specialist to manager to director to VP; and extramural contributions to the profession.
Articles due by: 1 March 2021
Publication:  Throughout April

MAY 2021

Topic: Update on the EU IVDR and MDR

Leads: Gert Bos, PhD, FRAPS, and Sue Spencer
Description: May 2021 marks the deadline for compliance with the EU MDR and the one-year countdown to the 2022 compliance date for the IVDR. Articles for this issue will provide an ‘update on the countdown’ for those two deadlines, examining the last-minute challenges, the longer-term impact of COVID-19, and advice and discussion around best practices relating to engagement with notified bodies, distribution, and manufacturing.
Articles due by: 1 April
Publication:  Throughout May

JUNE 2021

Topic: Nutrition in Health and Disease Management, and the Gut Microbiome

Leads: Manfred Ruthsatz, RPh, DABT, RAC, FRAPS, and Andrea Wong, PhD
Description: 2021 marks the 6th annual RAPS series on nutrition in health and disease management, augmented by articles on the gut microbiome. Authors and reviewers, who are global leaders in their respective areas of specialty and expertise, produce a line-up of in-depth articles on food, specialized nutrition, personalized nutrition, and dietary supplements from regulatory, trade, marketing, and legal standpoints across the globe.
Articles due by: 3 May
Publication: Throughout June


Topic: Artificial Intelligence

Lead: Gert Bos, PhD, FRAPS
Description: The articles in this issue will examine ways in which the regulatory profession can draw on AI to help navigate the complexities and fluidity of the global regulatory landscape to improve the speed, accuracy, quality, and overall outcome of their work.
Articles due by: 3 May
Publication: Throughout June

JULY 2021

Topic: Real-World Evidence and Data

Leads: Daniel Mannix, PhD, FRAPS, and Alan Minsk, JD
Description: In examining real-world evidence and data in the regulatory context, this issue will highlight case studies and success stories, with a focus on safety and effectiveness, generating evidence, clinical trials and study design, and regulatory considerations for using RWE and RWD.
Articles due by: 3 May
Publication:  Throughout July


Topic: Alternative Global Regulatory Pathways

Lead: Editorial Advisory Committee
Articles due by: 1 July
Publication: Throughout August


Topic: Diversity in Regulatory Affairs

Lead: Editorial Advisory Committee
Description Articles will address diversity, equity, and inclusion in the regulatory workplace in both small and large companies, preferably based on their experiences in addressing DEI and sharing with readers what they have done, the outcomes, and the challenges, successes/failures along the way.  
Articles due by: 2 August
Publication:  Throughout September


Topic: Quality and Compliance

Lead: Editorial Advisory Committee
Articles due by: 2 August
Publication:  Throughout September


Topic: Vaccines, Advanced Therapies, and Biologics

Leads: William Sietsema, PhD, and Jocelyn Jennings, MS, RAC
Description: Products regulated by the Center for Biologics Evaluation and Research are becoming increasingly complex, as are the regulatory issues related to the safety, demonstration of efficacy, and authorization to market these products.  This issue will feature articles about regulatory aspects of cell and gene therapies, vaccines, blood products, biosimilars, medical devices and their device combination products. The issue will also include articles examining the continued effect of COVID-19 on biologic development and regulatory interactions.
Articles due by: 1 September
Publication: Throughout October


Topic: Global Regulations and Rewards for Pediatric Drug Development

Leads: Linda McBride, RPh, RAC, and Lydia Wen, BPharm
Articles due by: 1 October
Publication: Throughout November


Topic: APL and the Role of Social Media

Leads: Linda Pollitz, RAC, and Moulakshi Roychowdhury, PharmD, JD
Description: Articles will cover latest trends in regulatory advertising and promotion, including FDA guidance documents, enforcement trends, and how regulatory professionals can apply recent guidance and enforcement to advertising, promotion and labeling reviews.
Articles due by: 1 November
Publication:  Throughout December