News

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).

Permalink


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.

Permalink


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.

Permalink


New course on 21CFR11

Wed 24 May 2017 @ 11:00

Zenosis, the leading provider of eLearning for the medicinal products industry, has announced the release of a new course, ICT01: Compliance with Regulation 21 CFR Part 11 on Electronic Records and Electronic Signatures.

Part 11 of Title 21 of the US Code of Federal Regulations (21CFR11) sets out requirements that computer systems must meet to satisfy the Food and Drug Administration (FDA) that electronic records and electronic signatures provided by those systems are trustworthy and reliable to the same extent as paper counterparts. The regulation sets out controls and procedures which need to be established and followed for relevant computer systems in FDA-regulated environments. An FDA-regulated environment is a ‘GxP’ environment operated by an organisation involved in activities leading to the marketing of drugs or medical devices in the USA; examples are drug manufacturing sites, medical device manufacturing sites, analytical laboratories, clinical investigational sites, and nonclinical study laboratories.

21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form ñ that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records ñ from a humble spreadsheet program to a complex information management system.

Companies that market or intend to apply for approval to market drugs or medical devices in the USA must comply with 21CFR11, whether or not they are based in the USA. Suppliers to such companies of materials, equipment, or data that are subject to FDA regulation must also comply.

This course provides essential training for all personnel who use computer systems in GxP environments. It clarifies the complicated picture of regulatory requirements and enforcement discretion exercised by the FDA.

Permalink


Course update: The New Drug Application (NDA) for Marketing Approval in the USA

Fri 5 May 2017 @ 11:00

Zenosis, the leading provider of eLearning for the medicinal products industry, has released an updated version of its course on applications to the US Food and Drug Administration (FDA) for marketing approval of new drugs.

Course SUB09, The New Drug Application (NDA) for Marketing Approval in the USA, has been updated to take account of the FDA’s commitment letter for authorisation VI of the Prescription Drug User Fee Act, which applies for US fiscal years 2018 through 2022. In addition, information on submission of applications has been updated in accordance with the FDA’s requirements for mandatory use of electronic Common Technical Document (eCTD) formatting and for transmission via its Electronic Submissions Gateway from 5 May 2017.

Information has also been updated on expedited development and review programmes and on communications and meetings between applicants and the FDA.

Permalink