News

New course on medical devices

Mon 4 Mar 2019 @ 11:00

Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of its first course on medical devices, MD01: An Introduction to the Regulation of Medical Devices.

The course provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market products in Europe and the USA. It explains what medical devices are and gives examples of the various types. It outlines the principles of their regulation and the criteria for placing them on the market, and it identifies major players in regulation worldwide. It then outlines prominent characteristics of the regulation of medical devices in the USA and in Europe.

This module provides essential training for all personnel concerned with the development, regulatory compliance, or marketing of medical devices. It is especially suitable for induction training of entry-level staff.

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New course on Good Pharmacoepidemiology Practice

Tue 14 Nov 2017 @ 11:00

Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of a new course, PV07: Good Pharmacoepidemiology Practice.

Pharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. It provides a bridge between clinical pharmacology and epidemiology. The increasing demand for real-world evidence of the safety, efficacy and utility of medicinal products has focused greater attention on pharmacoepidemiological research. This module will help those who plan and conduct such research, and analyse and report the findings, to follow good practice.

Staff working in drug safety and pharmacovigilance or clinical research departments of pharmaceutical and biotechnology companies will benefit from this module. It will also be of value to healthcare professionals.

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More Zenosis courses approved by Royal Society of Chemistry and Faculty of Pharmaceutical Medicine

Fri 11 Aug 2017 @ 7:42

Zenosis, the leading provider of eLearning for the medicinal products industry, is pleased to announce that a further two of its courses have been awarded Approved Training status by the UK's Royal Society of Chemistry. They have also received Continuing Professional Development (CPD) accreditation from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians.

The courses are:

In addition the Faculty has granted CPD accreditation to:

Approval by the Society identifies good quality training that supports members in their continuing professional development. The Society's approval process is one of peer review, involving assessment against set criteria by members expert in their field.

CPD refers to the learning activities through which professionals develop their abilities and ensure that they remain competent and increasingly effective. CPD is encouraged in all professions and is formally required in some. It may be otherwise known as Continuing Professional Education (CPE) or, in the context of medicine, Continuing Medical Education (CME).

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New courses on generics and biosimilars in the USA

Tue 11 Jul 2017 @ 11:00

Zenosis, the leading provider of eLearning for the medicinal products industry, has released two new courses on generics and biosimilars in the USA:

SUB13 outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ëOrange Bookí is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the review and approval process carried out by the Food and Drug Administration (FDA). An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the lawís effects on industry players.

The course is up to date with the many final and draft publications released by the FDA in US fiscal year (FY) 2017 that provide guidance for industry on applications for approval of generic drugs. It is also up to date with the provisions of the second authorisation of GDUFA, applicable from FY 2018.

The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the FDA, have been established only in recent years.

The short course SUB14 describes the provisions of the Biologics Price Competition and Innovation Act, identifies criteria for licensing a follow-on biologic as ëbiosimilarí or ëinterchangeableí, specifies periods of market exclusivity that apply, and discusses patent infringement issues. Finally, it describes the provisions of the Biosimilar User Fee Act, which authorises the FDA to collect fees from follow-on biologics sponsors, to support review activities.

SUB13 will benefit staff working in regulatory affairs, medical affairs, clinical development, quality/CMC, analytical methods, and quality assurance departments, and other personnel who contribute to the development and registration of generic drugs. SUB14 will mainly benefit regulatory affairs staff concerned with the licensure of follow-on biological products.

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New courses on monoclonal antibodies

Tue 13 Jun 2017 @ 11:00

Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of two new courses on monoclonal antibody-based products:

Monoclonal antibodies (mAbs for short) are the leading products of biotechnology. Worldwide sales of mAb products are predicted to exceed $120 billion dollars by 2020. Drugs based on mAbs dominate the list of top-selling medicines worldwide. In addition, mAbs have many uses in medical diagnosis, in laboratory analysis, and in the biotechnology industry itself.

ESS02 introduces the learner to monoclonal antibodies, explaining how mAb-based products work, how they are made, and the many uses to which they are put.

SUB12 addresses characteristic issues influencing the registration of medicinal products based on mAbs, for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture. This course focuses on distinctive issues in the production and testing of mAbs, in the context of relevant regulatory guidance. It discusses manufacturing quality, nonclinical and clinical issues, and aspects specific to radiolabelled mAbs. Finally, it identifies the pathways for applications to conduct clinical trials and to market mAb-based products in Europe and the USA.

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