Proposal Submission

Applicant
(Person in charge) 		Name: Michael Schmitz
Position: Director, International Advocacy
Organization: US Pharmacopeia
Country: United States
E-mail: michaelschmitz@usporg
Topic Promoting the adoption of rigorous regulatory pathways for Biosimilars
Proposal Content
(Describe your proposal, including potential areas of collaboration, purpose, and expected impact.) 		Rigorous regulatory pathways are vital to ensure only quality-assured biosimilars reach patients and substandard products are kept from entering the market However, rigorous regulatory pathways for biosimilars are not in place in every APEC economy The objective of the proposed program is to share best practices across APEC economies, including those from developed economies with an established track record of success with biosimilars The ultimate goal is to assist the adoption of rigorous regulatory pathways for biosimilars in APEC economies where these are currently lacking
Expected date 2024-10-28 to 2024-11-01 (Total 2 Days)
Expected Venue (Economy) Republic of Korea or Peru APEC 2024 host economy or Canada
Expected No. of Guests 100 Open
Expected Total Cost of the Event $100,000
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