2018 Editorial Calendar – RAPS Regulatory Focus
January - Regulatory Policy and Trends
Description: Articles will cover regulatory intelligence and address the following topics: identifying regulatory trends, analyzing how ripples and shifts in the landscape will need to be addressed by companies, forecasting the future of the regulatory landscape, and determining the impact to internal and external Regulatory Policies.
Leads: Meredith Brown-Tuttle and Alan Minsk
Call for Articles: August 2017
Submission Date: 1 November (final article submitted for review)
Publication Date: Throughout the month of January (articles on-line)
Topic Summary: 5 February (with authors and a summary of each article and links)
February - Regulatory Intelligence, Policy and Trends
Description: A variety of regulatory topics
Leads: Editorial Advisory Committee
Call for Articles: September
Submission Date: 27 November (final article submitted for review)
Publication Date: Throughout the month of February (articles on-line)
Topic Summary: (with authors and a summary of each article and links)
March - Regulatory Operations, including CTD publishing and electronic submission acceptability around the world
Description: The promise of a fully electronic regulatory department and submissions has been ongoing since the implementation of CANDAs in the late 90s; while we have come a long way, there is still much progress to be made. This month will explore the progress made as well as what to expect in the coming years for both drug and device submissions globally. Potential articles for this month could address regulatory operations, introduce electronic publishing, cost of outsourcing electronic publishing, status of electronic publishing around the world, CTD format/eCTD implementation, acceptance and continued use of paper publishing, and an update on medical device electronic publishing.
Lead: Meredith Brown-Tuttle
Call for Articles: October
Submission Date: 2 January (final article submitted for review)
Publication Date: Throughout the month of March (articles on-line)
Topic Summary: 2 April (with authors and a summary of each article and links)
April - Expanded Access, Rare Diseases, and Orphan Products
Description: Articles in this issue will explore the changing regulatory requirements of rare disease, orphan products and expanded access so that the regulatory professional is armed with the appropriate information when asked about this topic as more companies are exploring this arena.
Leads: Meredith Brown-Tuttle and Carol Vierling
Call for Articles: November
Submission Date: 31 January (final article submitted for review)
Publication Date: Throughout the month of April (articles on-line)
Topic Summary: 7 May (with authors and a summary of each article and links)
May - Conditional Approval Pathways and Strategies
Description: This month will concentrate on conditional approval pathways and strategies and individual articles and case studies could cover breakthrough therapy designation, fast track, Subpart E, Subpart H, rolling review, EU accelerated programs, treatment INDs, drug shortages, priority review by FDA, adaptive pathways like PRIME by EMA, and Canada’s conditional approval pathway, notice of compliance with conditions (conditional approval with company commitment to comply), drug submission priority review, and special access program.
Lead: Monique Carter
Call for Articles: December
Submission Date: 26February (final article submitted for review)
Publication Date: Throughout the month of May (articles on-line)
Topic Summary: 4 June (with authors and a summary of each article and links)
June - Innovative Technologies, including 3D Printing, Combination Products, Stem cells, Vaccines
Description:
Leads: Allison C. Komiyama and Mary Speagle
Call for Articles: January
Submission Date: 6 April (final article submitted for review)
Publication Date: Throughout the month of June (articles on-line)
Topic Summary: 9 July (with authors and a summary of each article and links)
July – Nutrition, Health, and Disease Management
Leads: Manfred Ruthsatz and Andrea Wong
Call for Articles: February
Submission Date: 7 May (final article submitted for review)
Publication Date: Throughout the month of July (articles on-line)
Topic Summary: August (with authors and a summary of each article and links)
August - Risk Management for Devices and Pharmaceuticals
Leads: Michael Sprafka, Darin Oppenheimer and Peggy Berry
Call for Articles: March
Submission Date: 28 May (final article submitted for review)
Publication Date: Throughout the month of August (articles on-line)
Topic Summary: September (with authors and a summary of each article and links)
September - Advertising, Promotion, Labeling
Leads: Linda Pollitz and Marcela Saad
Call for Articles: April
Submission Date: 9 July (final article submitted for review)
Publication Date: Throughout the month of September (articles on-line)
Topic Summary: 1 – 8 October (with authors and a summary of each article and links)
October - The new US Regulatory Landscape
Description: A look at the
FDA Reauthorization Act, 21st Century Cures Act, and the new Trump Administration, and how changes are affecting how products are regulated in the US.
Lead: Pallavi Trivedi
Call for Articles: May
Submission Date: 6 August (final article submitted for review)
Publication Date: Throughout the month of October (articles on-line)
Topic Summary: 5 November (with authors and a summary of each article and links)
November – Global IVDs
Lead: Marcela Saad
Call for Articles: June
Submission Date: 27 August (final article submitted for review)
Publication Date: Throughout the month of November (articles on-line)
Topic Summary: 3 December (with authors and a summary of each article and links)
December - Securing the Supply Chain, including track and trace, falsified medicines, cybersecurity, UDI
Description: Regulatory agencies are urging the healthcare industry to implement many measures to help secure the supply chain. To address this issue, articles in December will cover a variety of topics including: drug product supply through selection of more than one supplier of Active Pharmaceutical Ingredients (APIs) or excipients and the most reliable route to destination for clinical trial material; drug product security through serialization and the process for establishing a counterfeit unit in your organization; identifying possible sources of counterfeiting products including unauthorized compounding pharmacies and others. How do you report suspected counterfeit material to the agencies and the police? Drug product quality through cold chain management and select warehouses and distributors with a valid license. Since regulatory agencies are increasingly interested in understanding the whole supply chain, how is this reflected in submissions and variations? What role does regulatory play in this field? In addition, articles covering an overview of current regulations (Good Distribution/Transport Practices, Serialization, Falsified Medicines Regulations, etc.) for some of the major markets would be of great benefit to readers.
Leads: Siegfried Schmitt and Feng Yu
Call for Articles: July
Submission Date: 1 October (final article submitted for review)
Publication Date: Throughout the month of December (articles on-line)
Topic Summary: 7 January (with authors and a summary of each article and links)
2019 Editorial Calendar (Draft)
January 2019 - Regulatory Intelligence and Strategy
February 2019 - Biosimilars
June 2019 Combination Products
Other Topics
- How to Prepare for Health Authority Meetings, including FDA AdComms
- Regulatory Changes in Canada (Health Canada regulations) – fall 2018; new regulations in place by 2019
- Global Regulations and Rewards for Pediatric Drug Development
- International Compendium of Regulations and Best Practices for Meeting with Health Authorities
- Clinical Trial Applications: Global Regulations and Best Practices – a series of electronic publications covering Australia, Canada, EU, Japan, UK
- Device Lifecycle Management; import/export regulation for marketed and investigational products; Canada, US, EU - article series
- Global Orphan Drug Regulations
- Regulatory Harmonization
- Brexit
- India’s New Regulations
- Advanced Therapies
- Change Management
- MDR
- View from the Corner Office – Executive Interviews
- Case studies or explanations of how 21st Century Cures and FDARA have led to more meetings or faster reviews of medical products (later in 2018) but we should be seeing some companies getting 8-month reviews for generic drugs
- RMAT designations and new meetings with FDA because of these new laws
Other Regulatory Focus Categories for Feature Articles
- Advertising, Promotion and Labeling
- Biologics and Biosimilars
- Biotechnology*
- Business and Economics (Regulatory Business Acumen)
- Ethics
- Medical Devices*
- Pharmaceuticals*
- Policy (Government, Regulatory Bodies, Law and Legislation)
- Quality and Compliance
- Regulatory Profession (Education and Professional Development)
- Science and Research (Regulatory Science and Leading Edge Technology)
*monthly e-letter topics