RAPS Regulatory Focus – 2021 Editorial Calendar

2022 Editorial Calendar

AUGUST 2021

Topic: Alternative Regulatory Pathways

Lead: Siegfried Schmitt, PhD
Description: There are various reasons regulatory agencies develop alternative regulatory pathways (e.g., accelerated/conditional approval, breakthrough therapy/PRIME designations, emergency use authorization, advanced therapy medicinal products). This could be to provide faster or easier access to certain treatments for specific patient groups (e.g., pediatrics), specific illnesses (e.g., rare diseases), specific treatments (e.g., tissue engineered products), or for public health reasons (e.g., Covid-19 vaccines). Articles for this issue could address:

• Country, regional, or supranational regulations;
• Practical experience with these alternative pathways; or
• Provide an overview of treatments approved via particular pathways; literature reviews; or an historic analysis.

Articles due: 11 August 2021
Publication: Throughout August
 

SEPTEMBER 2021

Topic: Diversity in Regulatory Affairs

Lead: Editorial Advisory Committee
Description: Articles in this issue should address diversity, equity, and inclusion (DEI, see outline below) in the regulatory workplace, from both the employee and manager/employer perspectives in small and large companies or agencies. These articles should not be presented as opinion pieces or commentaries and should include supporting references from current literature. Diversity refers to differences within the workplace setting, including differences in race, ethnicity, gender, gender identity, sexual orientation, physical ability, age, and socioeconomic class. Equity describes efforts to ensure all aspects of, and opportunities within, a workplace are fair, accessible, and result in equally beneficial outcomes for all employees. Inclusion is the process of ensuring everyone in a workplace has a sense of belonging.

Possible topics:

• Manager/employers could describe and critically assess efforts to address DEI, sharing with readers details of implemented programs and associated costs, the challenges, successes/failures along the way, how challenges/failures were addressed, and outcomes.
• Employees could describe individual or collective efforts to persuade management to address DEI and/or the experiences that prompted them to motivate for such a program or provide a brief account and critical assessment of their experience with a particular DEI program.
• Reports/analyses of findings from DEI surveys conducted among employees, companies/agencies, or management/supervisors.
• Reports/analyses of outcomes, focusing on productivity, employee retention, return on investments.
• DEI recruitment policies and practices in the regulatory space, especially smaller companies/agencies.

Articles due: 30 August
Publication:  Throughout September
 

SEPTEMBER 2021 – Fall RF QUARTERLY

Topic: Quality and Compliance

Lead: Editorial Advisory Committee
Description: Articles will focus on quality and compliance at all stages within the clinical, laboratory, and manufacturing settings in the US, EU, and elsewhere, and could address:

• Good clinical, laboratory, and manufacturing practice (during COVID-19 pandemic; history and development; product quality and patient safety)
• Regulatory and guidance documents (ICH, EU, US, China, HealthCanada, etc)
• Role of the quality unit
• Types of inspection
• Data integrity
• Enforcement
• Quality management systems (background and key elements)
• CAPA management
• Safety testing and standards
• Informed consent, review boards, ethics committees, data-monitoring committees.

Articles due: 11 August
Release date:  1 September
 

OCTOBER 2021

Topic: Vaccines, Advanced Therapies, and Biologics

Leads: William Sietsema, PhD, and Jocelyn Jennings, MS, RAC
Description: Products regulated by CBER 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: 1 September
Publication: Throughout October
 

NOVEMBER 2021

Topic: Global development for pediatric products

Leads: Linda McBride, RPh, RAC, and Lydia Wen, BPharm
Description: Development of products for the pediatric population can be challenging but bringing a product to market that addresses the needs of patients, caregivers, and the medical community is tremendously rewarding. Understanding the regulations, requirements, and incentives, as well as precedence, is critical in the development and execution of the regulatory strategy.

• Recent approvals for drugs and biologics
• Recent clearances for medical devices
• Choice of control groups in clinical trials
• Considerations with modeling and extrapolation
• EU Pediatric Regulation changes under discussion at EMA
• Challenges for global plan development
• Application of model-informed drug development (MIDD)
• Rare pediatric disease designation successes (and failures)

Articles due: 1 October
Publication: Throughout November
 

DECEMBER 2021

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: 1 November
Publication:  Throughout December
 

DECEMBER 2021 – Winter RF QUARTERLY

Topic: 2021 RAPS Convergence

Leads: Editorial Advisory Committee
Description: No submissions for this issue -- articles will be based on presentations from 2021 RAPS Convergence
Release date:  1 December