NOTICIAS Y EVENTOS

According to Medical Devices Regulation and In Vitro Diagnostic Medical Devices, Notified Bodies have to establish lists of their standard fees for conformity assessment activities and make them available to the public.

Request for approval of OOS.

The formality in quality risk management is not a binary concept (i.e. formal/informal).

While the pharmaceutical industry will be as affected as any other by the new Regulation on EU packaging and packaging waste, it would also enjoy some limited exemptions under the current proposals.

From the 1st of January 2023 Croatia adopted the euro.

Billev Pharma East will be present at the annual stakeholders meeting as a representative of EUCROF.

EMA has updated its validation checklist for type II non-clinical variations.

Several European regulators provide perspective on the use of mechanistic models in a complex generic drug development.

AI has the potential to greatly impact the regulatory affairs industry by helping with decision-making, detecting deficiencies in documentation, and automating tasks such as document generation and regulatory updates. It can also be used in collaboration with other companies and manufacturers to improve work efficiency and gain insights into drug content and public perception.

A distribution plan should be prepared, including the target groups, the method and timing of distribution.

Unlike the previous practice, raw data are now stored in electronic structured formats.

The draft guideline covers the scientific and technical aspects of study designs used to support BE assessments.

Billev Pharma East can act as an authorised representative to assist you in complying with European legal requirements.

Today, the European Commission has proposed an extension of the transition period to certify medical devices.