Drug Discovery World

MARCH 29, 2023

Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

Clinical Trials 130

Clinical Trials Biosimilars Pharma Companies Production 130

Agency IQ

JULY 8, 2024

Several webinars and training sessions are geared towards ISO identification of medicinal products (IDMP) standards which is referred to as Substance, Product, Organization, Referentials (SPOR) data management services. Some “add-on” regulatory data protection may also be converted to market exclusivity.

Regulations 40

Regulations Pharmaceuticals Production Compliance 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

DECEMBER 1, 2023

Start Date End Date Event Event Type Organization 12/01/2023 12/01/2023 BIVDA Environmental Working Party Webinar/Seminar ( CLOSED ) British In Vitro Diagnostics Association (BIVDA) 12/04/2023 12/04/2023 HMA/EMA Big Data Stakeholder Forum 2023 Webinar/Seminar ( OPEN ) European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) 12/04/2023 12/04/2023 (..)

Regulations 40

Regulations Clinical Trials Production Biosimilars 40

Agency IQ

OCTOBER 27, 2023

A wide range of other meetings that will be occurring this month, with various webinars, committee meetings, and workshops spanning a variety of topics. 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

MARCH 29, 2024

This will include a number of conferences, webinars, and training sessions, as well as a long-awaited EMA workshop on psychedelics. 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 Biosimilars Clinical Trials 40

Agency IQ

MAY 31, 2024

Many of these webinars and trainings sessions are geared towards medical devices and in vitro diagnostics (IVDs). There will also be a number of noteworthy conferences taking place this month pertaining to the vaccine and medical technology industries. s Medicines and Healthcare products Regulatory Agency (MHRA).

Regulations 40

Regulations Production Compliance Pharmaceuticals 40