Key regulators featured in RAPS Convergence 2021 health authority forums

Regulatory NewsRegulatory News
| 12 September 2021 | By Kari Oakes 

Dr. Peter Marks

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, deputy director of Japan’s Ministry of Health, Labor and Welfare.
In Japan as elsewhere, regulators are building a regulatory framework that addresses software as a medical device (SaMD), and one topic at Monday’s forum will be the digital transformation action strategies undertaken by PMDA to address SaMD issues. The PMDA session will also provide an update on the amendment of the Pharmaceuticals and Medical Devices act that was implemented in September 2020.
The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) has a slate of seven staff members on tap for its forum, including Timothy Stenzel, director of the office of in vitro diagnostics at CDRH. William Maisel, director of the office of product evaluation and quality at CDRH, and other top center officials are also on the roster for the forum.
Later on Monday, Peter Marks will represent the FDA’s Center for Biologics Evaluation and Research (CBER). Marks, CBER’s longtime head, was also featured in Sunday’s opening plenary session and is again making himself available to RAPS attendees. On Sunday, Marks spoke of both the stresses and the opportunities pandemic-related adjustments have afforded CBER. (RELATED: Convergence: Plenary probes how FDA, EMA will move forward, Regulatory Focus 12 September 2021)
Tuesday’s health authority forum features Peter Stein, FDA’s director of the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER). At FDA, Stein’s office oversees how investigational drugs are studied, and provides regulatory oversight for marketing approval for innovator drugs, and new indications for drugs already on the market.

RAPS Convergence 2021 Health Authority Forums


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