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2020 Editorial Calendar – RAPS Regulatory Focus

 

January – Changing Regulatory Landscape, Strategy and Global Policy

Description: Regulatory affairs touches all aspects of the product lifecycle, including the development, registration and post-registration phases. The actual activities can be different in each phase, but the responsibility of the regulatory professional encompasses both strategic and tactical deliverables. The articles on this theme address the increasing role and importance of the regulatory professional in each of these phases.
Leads:  Editorial Advisory Committee
Call for Articles: 4 November 2019
Submission Date: 2 December (final article submitted for review)
Publication Date: Throughout the month of January (articles on-line)
Monthly Summary:  3 February
 

February – The Changing Role of Regulatory Professionals

Description: The what we communicate in regulatory is important to conveying messages, but the how we communicate is more critical for stakeholder understanding of the message and to influence both the dialogue and subsequent decision-making. Therefore, the development and delivery of a targeted message by regulatory professions to the audience is vital. Thoughtful creation, planning and delivery of the content heightens the relevance of the regulatory message delivered.
Leads: Linda McBride
Call for Articles: 2 December 2019
Submission Date: 6 January (final article submitted for review)
Publication Date: Throughout the month of February (articles on-line)
Monthly Summary: 2 March
 

March – Regulatory Ethics and History

Description: Ethics is the assumed hallmark and unequivocal standard behind all elements of regulatory affairs and compliance. This issue seeks to examine various perspectives on this essential concept. Desired contributions will explore ethics and compliance with broad applicability to the field. Articles are sought evaluating the evolution of regulatory compliance from examples of breaches that shaped current practices, delineation of the standards to be followed in maintaining a daily pattern of compliance in regulatory activities, what, if any, “special” standards or activities must be followed to ensure ethics in specific elements of product evolution such as clinical studies or advertising/marketing and current trends in the enforcement of regulatory ethics.
Lead: Peter Takes
Call for Articles: 6 January
Submission Date: 3 February (final article submitted for review)
Publication Date: Throughout the month of March (articles on-line)
Monthly Summary:  1 April
 

Q1 RF Article Series: Strategic Role of the Regulatory Professional

Description: With the need of regulatory science to keep up the pace with increased innovation and complexity of medical products, the role of the regulatory professional has become ever more strategic. As such, the Q1 2020 Regulatory Focus article series will explore the expanding strategic role of the regulatory professional.
Article Submission Date: 1 January
Release Date/ Email to Members: Wednesday, 4 March
Ask Me Anything: Wednesday, 8 April
 

April – MDR/IVDR

Description: The latest on MDR/IVDR implementation and acceptance.
Leads: Gert Bos and Sue Spencer
Call for Articles: 3 February
Submission Date: 2 March (final article submitted for review)
Publication Date: Throughout the month of April (articles on-line)
Monthly Summary:  4 May
 

May – Risk Management, Dealing With Contractors, Vendors and Mitigating Risk

Description: Quality risk management is a key component and a “must have” requirement for a compliant quality system. In regulatory affairs, risk management is particularly important when selecting suppliers and service providers. These third parties can have a fundamental effect on the validity and compliance of data, systems and operational processes. Articles and case studies should focus on how risks are addressed and managed. Possible topics include:
  • data and records management system suppliers and hosts (e.g., for (pharmaco)vigilance or for adverse events reporting)
  • third party affiliates, agents or representatives
  • outsourced RA functions (e.g., for legacy products)
  • contracted interim RA managers
Lead: Siegfried Schmitt
Call for Articles: 2 March
Submission Date: 6 April (final article submitted for review)
Publication Date: Throughout the month of May (articles on-line)
Monthly Summary: 1 June
 

June – Nutrition in Health and Disease Management

Leads: Manfred Ruthsatz and Andrea Wong
Call for Articles: 1 April January
Submission Date: 4 May (final article submitted for review)
Publication Date: Throughout the month of June (articles on-line)
Monthly Summary:  1 July
 

Q2 RF Article Series: Shifting Global Regulatory Landscape

Article Submission Date: 1 April
Release Date/ Email to Members: Wednesday, 3 June
Ask Me Anything: Wednesday, 8 July
 

July – Global Regulatory Strategy for Cell and Gene Therapy 

Description: Basic requirements, landscape, compare and contrast regions, in use therapies and reimbursement.
Leads: Siegfried Schmitt and Lydia Wen
Call for Articles: 4 May
Submission Date: 1 June (final article submitted for review)
Publication Date: Throughout the month of July (articles on-line)
Monthly Summary:  3 August
 

August – Global Clinical Trials, Clinical Trial Application

Description: Despite the efforts of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to produce a series of guidelines for the development of drugs and biologics and to standardize the format of marketing applications, the format of clinical trial applications and Health Authority review process of these remain quite different between countries. The articles on this theme address these divergent formats and processes and provide options on how to potentially navigate the regulatory aspects of clinical trials more simply.
Leads:  Dan Mannix
Call for Articles: 1 June
Submission Date: 6 July (final article submitted for review)
Publication Date: Throughout the month of August (articles on-line)
Monthly Summary:  1 September
 

September – MDR Update with a Focus on IVDR

Description: The latest on MDR/IVDR implementation and acceptance.
Leads: Gert Bos and Sue Spencer
Call for Articles: 6 July
Submission Date: 3 August (final article submitted for review)
Publication Date: Throughout the month of September (articles on-line)
Monthly Summary: 5 October with January Call for Articles
 

Q3 RF Article Series: Regulatory Strategy for Drugs and Devices

Article Submission Date: 1 July
Release Date/ Email to Members: Wednesday, 2 September
Ask Me Anything: Wednesday, 30 September
 

October – Regulatory Toolbox, the Tools Regulatory Professionals Need and Where to Find Them

Description: Regulatory professionals require the most current tools necessary to stay abreast of the latest changes occurring in the United States and worldwide. Emphasis will be placed on websites, guidances, meeting minutes, Food and Drug Administration correspondence including warning letters, enforcement actions, 483s, notices, etc. How to interpret the meanings behind regulatory agency actions and documentation will be discussed.
Lead: Bob Schiff
Call for Articles: 3 August
Submission Date: 1 September (final article submitted for review)
Publication Date: Throughout the month of October (articles on-line)
Monthly Summary: 2 November
 

November – Policy Changes, ICH, PIC/S, Regulating Future Policies

Lead: Mary Speagle
Call for Articles: 1 September
Submission Date: 5 October (final article submitted for review)
Publication Date: Throughout the month of November (articles on-line)
Monthly Summary:  1 December
 

December – APL and the Role of Social Media

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.
Leads: Linda Pollitz and Moulakshi Roychowdhury
Call for Articles: July
Submission Date: 5 October (final article submitted for review)
Publication Date: Throughout the month of December (articles on-line)
Monthly Summary: 5 January
 

Q4 RF Article Series: Regulatory Intelligence and Policy

Article Submission Date: 1 October
Release Date/ Email to Members: Wednesday, 2 December
Ask Me Anything: Wednesday, 6 January
 

Recurring Topics for Regulatory Focus Feature Articles

  • Advertising, Promotion and Labeling
  • Biologics and Biosimilars
  • Biotechnology
  • Business and Economics
  • Ethics
  • Generics
  • Government, Regulatory Bodies, Law and Legislation
  • Leading-Edge Technology
  • Medical Devices
  • Pharmaceuticals
  • Policy
  • Quality and Compliance
  • Regulatory Business Acumen
  • Regulatory Profession (Education and Professional Development)
  • Regulatory Science and Research
  • Vaccines