Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities

Autor: Bolislis, Winona Rei, de Lucia, Maria Lucia, Dolz, Felipe, Mo, Runyi, Nagaoka, Makoto, Rodriguez, Heraclio, Woon, May Li, Yu, Wei, Kühler, Thomas C.

Publikováno v: In Clinical Therapeutics January 2021 43(1):124-139

Impact Assessment of Divergence on Post-approval Changes Classifications of Latin America Region With Europe and the United States, and Propositions to Harmonize Classification Based on Risk as a Path to Build the Trust Between National Regulatory Agencies

Autor: De Lucia, Maria Lucia, Comesaña, Christian, Rodriguez, Heraclio, Dangy-Caye, Agnes

Publikováno v: In Clinical Therapeutics February 2024 46(2):164-172

Worldwide Regulatory Reliance: Launching a Pilot on a Chemistry, Manufacturing, and Control Post Approval Change for a Vaccine.

Autor: Gastineau T; Sanofi, Lyon, France., Ban C; Sanofi, Toronto, Canada; Cynthia.ban@sanofi.com., Basso A; Sanofi, Lyon, France., Brehme F; Sanofi, Berlin, Germany., Silva AL; Sanofi, Sao Paulo, Brazil; and., Faure O; Sanofi, Lyon, France., Palaire LL; Sanofi, Lyon, France., Persaud P; Sanofi, Toronto, Canada., Rodriguez H; Sanofi, Panama City, Panama.

Publikováno v: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2024 Aug 23; Vol. 78 (4), pp. 388-398. Date of Electronic Publication: 2024 Aug 23.