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    Convergence: Regulatory considerations in advancing gene and cellular therapies

    When developing a regulatory submission for a gene or cellular therapy, it’s essential to keep the basics in mind, such as how to demonstrate the product’s identity, purity, and potency, Haroon Hashmi, PhD, told attendees at RAPS Convergence 2021.   “Even when we think about these complex technologies -- new emerging technologies -- certain regulatory principles always stay in place,” said Hashmi, senior vice president at Ziopharm Oncology, which has developed the Slee...
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    Convergence: First-year experience with Japan’s amended medical device rules

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is providing priority review for certain innovative medical devices and has implemented a post approval change management process to allow for continuous improvement of medical devices.   The changes are part of the Amendment of the Pharmaceutical and Medical Device Act (PMD Act), which was implemented in September 2020. Officials from Japan’s Ministry of Health, Labour and Welfare (MHLW) and the PMDA provided a...
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    Key regulators featured in RAPS Convergence 2021 health authority forums

    On Monday, RAPS Convergence 2021 attendees will have the opportunity to hear from global regulators during three health authority forums. The presentations will highlight key topics and updates relevant to each regulatory body in hour-long sessions.   The session featuring Japan’s Pharmaceutical and Medical Devices Agency (PMDA) features four Japanese regulators, including session leader Tetsuya Kusakabe, PMDA’s international coordination officer, and Kanako Sasaki, de...
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    Convergence: Plenary probes how FDA, EMA will move forward

    During the opening plenary session for RAPS Convergence 2021, leading regulators from the US and EU moved beyond the now-obligatory discussion of lessons learned from the pandemic to a substantive review of how the agencies are really faring a year and a half into the public health emergency of the COVID-19 pandemic.   Speaking to an audience of regulatory experts in attendance at the virtual conference, Janet Woodcock, acting commissioner of the US Food and Drug Admin...
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    RAPS honors 7 distinguished individuals and an advocacy group for contributions to the regulatory profession and patient health

    RAPS has recognized seven distinguished professionals and one patient advocacy organization with awards for their work to support the regulatory profession and advance public health. RAPS’ Founder’s Award, Community Leadership Award and Patient-Centered Health Award are presented annually during RAPS Convergence , the world’s largest conference dedicated to healthcare product regulation and regulatory issues. This year’s Convergence will take place virtually 12–15 Septemb...
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    US to continue international inspection cooperation, says Marks

    Some of the US Food and Drug Administration’s (FDA’s) pandemic-related changes are likely here to stay, a top FDA official told Focus .   In the leadup to RAPS Convergence 2021, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), spoke with Focus about how CBER’s pandemic pivot accelerated a trend toward global cooperation, and how the changes stand to benefit patients and industry going forward.   Business as usual came to a halt...
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    August’s Regulatory Focus: Alternative regulatory pathways

    Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Ja...
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    Chisholm, Falcone, Soo and Steffen named RAPS Fellows

    RAPS today announced the names of four exceptional senior regulatory professionals who will join the venerated ranks of RAPS Fellows . The 2021 RAPS Fellows are:   Orin Chisholm , FRAPS, BSc (Hons), GCULT, PhD, SFHEA, principal consultant, Pharmed, Sydney, Australia Robert Falcone , FRAPS, PhD, senior manager, regulatory affairs, Prestige Consumer Healthcare Inc., Tarrytown, NY Chin-Wei Soo , FRAPS, DRSc, global regulatory head, devices and combination products,...
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    Top FDA and EMA officials to kick off Convergence 2021

    RAPS will hold its annual Convergence, the world’s largest conference dedicated to healthcare product regulation and regulatory issues, 12–15 September . Convergence 2021 will be a live, virtual event featuring more than 100 educational sessions, presentations, panel discussions, speaker and author meet and greets, and other interactive sessions with more than 200 expert speakers.   The four-day conference will kick off with an opening plenary and panel discussion o...
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    New method to an old approach: A semiquantitative approach for determining probability of regulatory success for ASEAN markets

    An objective assessment guide for estimating the likelihood of obtaining regulatory approval for marketing authorization applications submitted to local regulatory agencies is critical to facilitate commercial launch planning. In this paper, we describe a harmonized guide designed to estimate the probability of regulatory success (PRS) in the Association of Southeast Asian Nations (ASEAN). This guide focuses on a standardized set of criteria for semiquantitative assessment...
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    Euro Convergence: Academic clinics should establish risk management programs for ATMP development

    Academic centers should establish risk management programs to successfully commercialize cell and gene therapy products and to be a viable partner with contract research organizations (CROs) and manufacturers in developing these therapies.   So asserted Lutz Uharek, a professor of internal medicine and founder and CEO of Xencura, at RAPS Euro Convergence 2021 on 12 May in discussing some of the challenges and opportunities for academic centers in developing cell and ge...
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    Euro Convergence: EU pediatric medicines regulatory framework needs simplification, optimization

    Industry would like to see some “pragmatic” changes to the regulatory process for pediatric medicines in the EU, according to a recent presentation at RAPS Euro Convergence 2021.   These changes include incorporating scientific discussion throughout a product’s life cycle, comparable reporting requirements for pediatric trials to those for adult trials, and optimization and simplification of pediatric investigation plan (PIP) procedures and compliance checks, said Thom...