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Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event

Stefano Accorsi
Head of Global Regulatory Intelligence and Policy at Chiesi Farmaceutici
Speaker

Profile

Stefano Accorsi holds a graduation in Chemistry at the University of Modena (Italy) and an Executive MBA at the Bologna Business School. He has been working in the International Regulatory Affairs for more than twenty years.

For eight years he has been responsible for Regulatory Affairs in the EU and for the Regulatory CMC (Chemistry, Manufacturing and Control) of the pharmaceutical group he used to work for.

Then, for fifteen years, he led a team at Chiesi Farmaceutici in charge of regulatory activities in North (except US), Central and South America, Africa, Russia, Middle East, Far East and Oceania.

Today is the Head of Global Regulator Intelligence and Policy at Chiesi and leads and develops the Company relationships with Regulatory Authorities world-wide, in collaboration with external industry associations, to support the regulatory policy agenda of Chiesi.

Stefano has had face-to-face meetings with many Regulatory Agencies around the world, such as Health Canada, COFEPRIS (Mexico), ANVISA (Brazil), NMPA (China), MFDS (South Korea), TFDA (Taiwan), TGA (Australia), PMDA (Japan).

Stefano is member of the EFPIA (European Federation of Pharmaceutical Industries and Associations) “International Regulatory Experts Group” (IREG) and of the Regulatory Experts Working Groups on China, South Korea/Taiwan and Turkey.

He is also member of the Regulatory Science Committee (RSC) of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and of the Regulatory Affairs Steering Committee (RASC) at the US Biotechnology Innovation Organization (BIO).

He has been invited to several national and international congresses on Regulatory Affairs as a speaker.

He was also an invited lecturer at the post-graduation Master in Regulatory Affairs at the University of Pavia (Italy).

Agenda Sessions

  • Reliance and Convergence in APAC: China, Japan and Australia

    09:10
  • Global Reliance and Convergence: Moving Towards Harmonisation

    16:15
  • Expedited Drug Development Regulatory Pathways in China

    09:50