Uncategorised

New Course: Assuring Data Integrity in Clinical Research

news, Uncategorised / By

We are pleased to announce the release of a new course: Assuring Data Integrity in Clinical Research Pharmaceutical, biotechnology and medical device companies and clinical researchers need to assure regulatory authorities of the reliability of the data that they generate during product development and testing – that is, to demonstrate data integrity. Practices that provide assurance […]

New Course: Assuring Data Integrity in Clinical Research Read More »

New Course: Assuring Data Integrity in the Manufacture of Medicinal Products

news, Uncategorised / By

We are very happy to announce the release of a new course: Assuring Data Integrity in the Manufacture of Medicinal Products. Pharmaceutical and biotechnology companies and researchers need to assure regulatory authorities of the reliability of the data that they generate or acquire during product development and manufacturing – that is, to demonstrate data integrity. Data

New Course: Assuring Data Integrity in the Manufacture of Medicinal Products Read More »

New course on Good Clinical Laboratory Practice

Uncategorised / By

We are delighted to announce the release of a new course: Good Clinical Laboratory Practice The work of analytical laboratories in examining biological samples is crucial in the diagnosis and treatment of patients, in public health screening, and in clinical research. Various published guidelines and consensus standards set out criteria that laboratories should meet to provide

New course on Good Clinical Laboratory Practice Read More »

New course on Good Quality Control Laboratory Practice

Uncategorised / By

We are pleased to announce the release of a new course: Good Quality Control Laboratory Practice [course details]. The medicinal products industry is heavily regulated by governments. Within the industry’s Good Manufacturing Practice (GMP) framework, analytical laboratories engaged in quality control (QC) of starting materials, intermediates, bulk products, finished products, and packaging need to comply with relevant

New course on Good Quality Control Laboratory Practice Read More »

New course on the 505(b)(2) application for marketing approval in the USA

Uncategorised / By

A 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ‘stand-alone’ NDA in that some of the data on which the applicant relies to demonstrate safety and efficacy have been obtained from publicly available sources rather

New course on the 505(b)(2) application for marketing approval in the USA Read More »

Accreditation update

Uncategorised / By

Our courses are undergoing a rolling programme of Continuing Professional Development accreditation by the well-respected CPD Certification Service (CCS).  CCS reviewers carefully assess each course before deciding whether to grant certification, and it will take some time to assess the full Zenosis library. To date, learners that successfully complete the following courses will receive a

Accreditation update Read More »

EU extends grace period for transition to Medical Device Regulation

Uncategorised / By

The European Union, recognising that many medical device manufacturers would be unable to meet the deadline for transition to the requirements of the Medical Device Regulation (MDR), have extended the grace period allowed for compliance with the new law. Prominent among the reasons for the postponement of the deadline is the inadequate number of third-party

EU extends grace period for transition to Medical Device Regulation Read More »