RAPS Regulatory Focus – 2022 Editorial Calendar

2022 Editorial Calendar

April 2022

Topic Specialist or generalist: Which is the path for you?
Lead Editorial Advisory Board

Description Articles for this issue could address:

• How to become a generalist/specialist
• What technical skills are required for each option?
• The pros and cons of each option?
• The value of RA programs (e.g., US, EU universities, etc.)
• Certification alternatives, e.g., RAC, CRM, CQA, CQE, CBA, etc.

 
Articles due 1 March 2022
Publication Throughout April 
 

May 2022

Topic Update on EU IVDR and MDR
Leads Gert Bos and Sue Spencer
 
Description With the date of application for the IVDR set for May 2022, the focus will be on companies’ readiness for the implementation, Notified Body conformity assessments, and obtaining the CE mark to avoid last-minute rush, as well as the impact of the extended transition periods the different classes of devices.
 
Articles due 1 April 2022
Publication Throughout May
 

June 2022

Topic Nutrition in health & disease management & gut microbiome
Leads Manfred Ruthsatz and Andrea Wong
 
Description These in-depth articles will focus on food, specialized nutrition, personalized nutrition, and dietary supplements from regulatory, trade, marketing, and legal standpoints across the globe.
 
Articles due 2 May 2022
Publication Throughout June
 

June 2022 – RF Quarterly

Topic Regulatory history
Leads Daniel Mannix and Robert Falcone
 
Description The lead editors have invited authors to write on PDUFA/GDUFA, conditional approvals, ICH, expedited development programs, pediatric drug regulation, and history of the NMPA and PMDA. Other articles could address orphan drug regulation and Animal Rule and human factor studies.
 
Articles due 2 May 2022
Publication Issue released 8 June (eToC + issue PDF emailed to members and posted to site)
 

July 2022

Topic Mentorship
Lead Irene Hseih
 
Description Mentorship provides a safe forum for regulatory professionals at all levels, allowing them to ask questions and receive advice on managing career decisions, seeking out opportunities for advancement, and more. An effective mentor-mentee relationship facilitates constructive exchange between the two parties, providing and receiving guidance, motivation, emotional support, and role modeling that empowers the participants and supports professional development and advancement. The lead author has invited articles on how to find a mentor; how to be a mentor; responsibilities and ethical considerations in mentoring. Other articles could address:

• Mentoring programs and Diversity, Equity, and Inclusion initiatives.
• Mentoring pitfalls and challenges: What happens when it’s not working out?
• Internships
• Peer-to-peer mentoring
• Reverse mentoring
• Company mentoring programs
• Formal mentoring educational programs
• Mentoring programs and DEI initiatives

 
Articles due 1 June 2022
Publication Throughout July
 

August 2022

Topic CMC regulatory issues
Lead Linda McBride
 
Description To be provided
 
Articles due 5 July 2022
Publication Throughout August
 

September 2022

Topic Risk assessment and mitigation
Lead Editorial Advisory Board
 
Description Articles for this issue could address:

• Risks to approval
• Risks to manufacturing
• Assessing risk cross-functionally
• Formally preparing risk assessments
• Managing risks to submission
• Commercial viability
• TPP, messaging, product claims
• APL considerations
• Market access and reimbursement

 
Articles due 1 August 2022
Publication Throughout September
 

September 2022 – RF Quarterly

Topic Strategy in regulatory affairs
Lead Peggy Berry
 
Description Articles for this issue could address:

• What is a regulatory strategy?
• How to define/develop a strategy
• Strategy as a “weaponized” quality
• Managing operational input and expectations
• RA as a business unit
• Global considerations in regulatory strategy
• Making a strategy understood at every level in the organization
• How to expand your drug’s potential

 
Articles due 1 August 2022
Publication Issue released 8 September (eToC + issue PDF emailed to members and posted to site)
 

October 2022

Topic OTC regulatory issues
Lead Editorial Advisory Board
 
Description To be provided
 
Articles due 1 September 2022
Publication Throughout October
 

November 2022

Topic 2022 RAPS Convergence
Lead Editorial Advisory Board
 
Description Articles for this issue will be based on presentations made at the 2022 RAPS Convergence.
 
Publication Throughout November
 

December 2022

The December issue will focus on two topics – the annual APL and the role of social media, and a second topic, Regulatory lessons learned from the pandemic.
 
Topic APL and the role of social media
Leads Linda Pollitz and Moulakshi Roychowdhury
 
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.
 
Topic Regulatory lessons learned from the pandemic
Lead Editorial Advisory Board
 
Description Articles could include, but not be limited to, topics such as:

• What worked, what didn’t?
• Is there a new normal? What will we hold on to, what will be return to?
• Is flexibility our new best friend?
• How can we prepare for the next one?
• How soon is too soon for EUA? What should be required?
• Impact on the regulatory job search: When geography ceases to be a limitation

 
Articles due 1 November 2022
Publication Throughout December

December 2022 – RF Quarterly

Topic Artificial intelligence
Leads Gert Bos and Koen Cobbaert
 
Description To be provided
 
Articles due 1 October 2022
Publication Issue released 8 December (eToC + issue PDF emailed to members and posted to site)