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

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

Agency IQ

OCTOBER 27, 2023

Upcoming Webinar Hosted by Xtalks Webinar/Seminar ( OPEN) Xtalks 11/6/2023 11/6/2023 What is the evidence for high-risk medical devices in the field of cardiovascular disease and diabetes?

Regulations 40

Regulations Pharmaceuticals Production Packaging 40

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

Agency IQ

OCTOBER 6, 2023

Taking a closer look, nearly half of the products were reviewed by the Office of Oncologic Diseases. The largest portion of reviews after that were 14% (3 NMEs) each with the Office of Neuroscience and the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine.

FDA 52

FDA Biosimilars Science Drugs 52

Agency IQ

AUGUST 2, 2024

For example, on July 25, the Hungarian presidency hosted an informal meeting of health ministers to discuss health issues, such as mitigating the effect of cardiovascular diseases and implementing the European Health Data Space (EHDS).

Regulations 40

Regulations Clinical Trials Production Trials 40