RAPS Regulatory Focus – 2023 Editorial Calendar

Updated 4 January 2023

2023 Editorial Calendar PDF

 

January 2023

Topic Advanced therapy medicinal products, incl. combinations
Lead Editorial Advisory Board

Articles due 1 December 2022
Publication Throughout January
 

February 2023

Topic eCTD submissions
Leads Editorial Advisory Board

Description Articles will examine all aspects of electronic common technical document submissions, from technical considerations and managing the submission team, to executing submissions within regional or country-specific requirements. Topics could include, but not be limited to:

  • Adapting to eCTD 4.0
  • How the EU Clinical Trial Regulation will affect RIM systems and tracking of CTAs
  • Identification of medicinal products, or IDMP
  • Preparing for the electronic transmission of premarket safety reports in ICH E2B(R3) format
Articles due 1 February 2023 (extended)
Publication Throughout February
 

March 2023 – RF Quarterly

Topic Patient-focused regulatory practice
Leads Steve Weber, MD, and Flora Siami, MPH

Description The US FDA describes patient-focused drug and device development (PFDD) as a systematic approach for ensuring patients’ experiences, perspectives, needs, and priorities are incorporated into the product development and evaluation processes. Articles focusing on pediatric and elderly patients and patient diversity are encouraged, as are those addressing regional or country-specific approaches to PFDD. Topics could include, but not be limited to:

  • Collection of patient information, preapproval and postmarket;
  • Analysis of the data and information, and their application to drug development and evaluation;
  • Tools and technologies needed for gathering/assessing the information;
  • Examination of data demonstrating the effectiveness and/or shortcomings and challenges; and
  • Overall impact on patients, regulators, and companies (outcomes, QoL, health costs, time to approval, R&D costs for companies.
Articles due 1 February 2023
Publication Issue released 8 March (eToC + issue PDF emailed to members; articles + PDF posted to the RAPS site)
 

April 2023

Topic Professional development and career advancement
Leads Robert Schiff, PhD, RAC, CQA, FRAPS; Peter Takes, PhD, RAC, FRAPS; and Irene Hsieh, MS

Description Topics could include, but not be limited to:

  • Technical knowledge vs. compliance mindset
  • Pathways to regulatory affairs – college; new hire; transition from other departments (quality, research, production, technical services, marketing)
  • Credentialing – perspectives from RAC members
  • Specializing in RA – submissions (domestic, global), clinical, commercial, labeling, compliance
  • Life as a regulatory professional – Small and large companies, consultant
  • Transitioning product lines/specialties
  • Transitioning from specialist to manager to director to VP
  • Reaching beyond your company – contributions to the profession
Articles due 1 March 2023
Publication Throughout March
 

May 2023

Topic Update on EU IVDR and MDR
Lead Gert Bos, MSc, PhD, FRAPS, and Sue Spencer, BSc (Hons)

Description To be provided  

Articles due 3 April 2023
Publication Throughout May
 

June 2023 – RF Quarterly

Topic Global regulatory health authorities and organizations
Lead Editorial Advisory Board

Description In this issue of RF Quarterly, articles will examine regulatory entities and practice in countries and regions beyond North America, e.g., India; Oceana; China; Japan; Middle East, African, Southeast Asia, and LATAM countries; the UK and EU; and Singapore. Entities could include drug/medical device regulatory agencies or organizations, e.g., the International Council for Harmonization, Association of Southeast Asian Nations, and the African Medicines Agency. The articles could encompass all or some of the following:

  • History/Background of RA in the given country/region, with a brief description of its standing/role in the regional/global regulatory landscape
  • Brief description of the regulatory entity and its regulatory roles
  • Drug approval pathways – highlight similarities/differences with more established regulatory sectors, eg, EU, US, Canada
  • Clinical trials
  • Drug development and manufacturing
  • Quality and compliance and regulatory enforcement
  • Strengths and challenges
Articles due 14 April 2023
Publication Issue released 8 June (eToC + issue PDF emailed to members; articles + PDF posted to the RAPS site)
 

July 2023

Topic Regulatory intelligence
Lead Linda Bowen, MSc, RAC, FRAPS

Description Topics could include, but not be limited to:

  • RI best practices
  • Communication, deliverables
  • Metrics, databases
  • Precedent, innovation, and sources
  • Artificial intelligence in regulatory intelligence
  • Commercially available RI acquisition and organization resources
  • Key important elements to pursue in RI acquisition
Articles due 1 June 2023
Publication Throughout July
 

August 2023

Topic CMC regulatory issues
Lead Linda McBride, BS

Description To be provided  

Articles due 5 July 2023
Publication Throughout August
 

September 2023 – RF Quarterly*

Topic Leadership in regulatory affairs
Lead Editorial Advisory Board
Description Articles for this issue could address:
  • Outline of levels of RA leadership and requirements thereof
  • Strategic thinking/soft skills
  • Goal setting for long-term-impact
  • Planning to be a leader: Important milestones to being a leader
  • Learning to influence people
  • Influencing without authority
  • Getting people to follow
  • The value of certification
Articles due 10 July 2023
*Publication A print version of this issue of RF Quarterly will be available to attendees at the 2023 RAPS Convergence in Montreal, QC, 3-5 October 2023. An eToC + issue PDF will also be emailed to members, and articles + the PDF will be posted on the RAPS site.
 

October 2023

Topic The EU Clinical Trials Regulation
Lead Daniel Mannix, PhD
 Description To be provided
 
Articles due 5 September 2023
Publication Throughout October
 

November 2023

Topic Regulatory science
Lead Editorial Advisory Board
Description To be provided

Articles due 2 October 2023
Publication Throughout November
 

December 2023 – RF Quarterly

Topic 2023 RAPS Convergence
Leads RAPS Editorial and Convergence staff
Description Articles for this issue of RF Quarterly will be based on presentations made at the 2023 RAPS Convergence, to be held in Montreal, QC, 3-5 October 2023.

Publication Issue released 8 December (eToC + issue PDF emailed to members; articles + PDF posted to the RAPS site)

For more information, contact Renée Matthews, Senior Editor, Regulatory Focus, at rmatthews@raps.org.