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2023 Editorial Calendar PDF
Topic Advanced therapy medicinal products, incl. combinations
Lead 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:
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:
Description Topics could include, but not be limited to:
Description To be provided
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: