Agency IQ

MAY 3, 2024

Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No. Start Date End Date Event Event Type Organization 4/30/2024 4/30/2024 Seminar No.

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

FDA Law Blog: Biosimilars

JANUARY 11, 2024

This day-long (FREE) seminar is a must-attend event for anyone in the pharmaceutical sector interested in understanding the “ins and outs” of doing business in the Territory, as well as an opportunity to interact with those who already have a keen understanding of doing business in Puerto Rico.

Pharmaceuticals 59

Pharmaceuticals Licensing Licensing Compliance 59

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science 40

Science Biosimilars FDA Production 40

Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Agency IQ

MARCH 29, 2024

regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0: regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

Regulations 40

Regulations Production Clinical Trials Biosimilars 40

Agency IQ

OCTOBER 6, 2023

For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. As AgencyIQ has previously discussed , developing biosimilars is an expensive process.

FDA 52

FDA Biosimilars Science Drugs 52

Agency IQ

MAY 31, 2024

Start Date End Date Event Event Type Organization 6/03/2024 6/03/2024 Product Management Service (PMS) Product UI and API training (access & navigation) Webinar/Seminar ( OPEN ) EMA 6/03/2024 6/07/2024 Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the E.U.:

Regulations 40

Regulations Production Compliance Pharmaceuticals 40