Hello, herewith the Table of Contents for July's Regulatory Focus, which examines real-world data and evidence and their application to approval processes, labeling, clinical use, and marketing of medical products.
Also included is a roundup of upcoming issues through October, including the September RF Quarterly.
Enjoy reading and stay well!
Renee
July's Regulatory Focus: Real-world data, real-world evidence
Table of Contents
Renée Matthews
HTML
- RWD, RWE, and improved patient outcomes: From FDA's Mini-Sentinel to real-world examples
Nancy Clementi, MD, Manya Deehr, JD, and William Clementi, PharmD, FCP
HTML │ PDF
- Regulatory considerations for real-world research studies in Europe
Stuart McCully, PhD
HTML │ PDF
- Considerations for regulatory application of RWD-generated external comparators
Debra A. Schaumberg, ScD, OD, MPH; and K. Jack Ishak, PhD
HTML │ PDF
- From real-world data to real-world evidence: An interregional perspective
Dave Li, MD, PhD; and Anna Baran, MD
HTML │ PDF
- New method to an old approach: A semiquantitative approach for determining probability
of regulatory success for ASEAN markets
Wan Lee Chow, BPharm (Hons); Julie O'Brien, PhD, PGDip; Rominder Singh, PhD; and
Tse Siang Kang, PhD, RAC
HTML │ PDF
Upcoming in Regulatory Focus
What's coming in August?
Articles during august will examine Alternative Regulatory Pathways. Look for this topic and more throughout August at Regulatory Focus.
And September?
For the September issue, Regulatory Focus will examine Diversity in Regulatory Affairs. The submission due date for articles has been extended to 31 August 2021. To contribute, email rmatthews@raps.org.
Call for articles
October monthly issue
In October, Regulatory Focus will cover Vaccines, Advanced Therapies, and Biologics. The submission due date for articles is 1 September 2021. To contribute, email rmatthews@raps.org.
Upcoming in RF Quarterly
Regulatory Focus launched the inaugural issue of RF Quarterly in mid-March. Each issue of RF Quarterly is comprised of original content, developed around a theme, as a member-exclusive benefit.
The summer issue, focusing on artificial intelligence, is now available.
The themes for the remainder of 2021 will be:
- Quality and Compliance in Regulatory Affairs (September)
- RAPS 2021 Convergence (December)
To contribute to the September issue of RF Quarterly, email rmatthews@raps.org.
For more information, see Guidelines for Authors and the 2021 Editorial Calendar.
------------------------------
Renee Matthews
Senior Editor
Rockville MD
United States
------------------------------