News

Fifty courses now available from Zenosis

Wed 23 Feb 2022 @ 16:49

grapl ltd, owner of the Zenosis library of eLearning for the medicines and healthcare products industries, is proud to announce that, with the release of two new courses on clinical research under the European Union’s recently implemented Clinical Trials Regulation, a total of 50 courses are now available in the library.

One of the largest collections of eLearning for the pharmaceutical, biotechnology and medical device industries and for healthcare professionals, Zenosis offers courses on:

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New courses on clinical research under the EU Clinical Trials Regulation released

Wed 23 Feb 2022 @ 12:27

grapl ltd, owner of the Zenosis library of eLearning for the medicines and healthcare products industries, is delighted to announce the release of two new courses on clinical research under the European Union’s recently implemented Clinical Trials Regulation:

The long-awaited implementation of the Regulation ushers in a simplified and harmonised process of authorisation and supervision of clinical trials in the European Economic Area. It establishes a harmonised procedure for gaining and maintaining authorisation for trials in up to 30 countries on the basis of a single electronic application per trial, and subsequent interactions, via a single EU online information system. It also mandates greater transparency of information on trials. The Regulation applies from 31 January 2022 and, after a grace period of one year, sponsors of all new clinical trials in the EEA must comply with it.

The CT11 course sets out the procedures that sponsors need to follow to gain authorisation to conduct clinical trials under the Regulation, and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT12 sets out the procedures that sponsors need to follow to conduct authorised clinical trials in compliance with the Regulation. The two courses therefore provide an ideal foundation for understanding and complying with the new law.

The existing course CT01, which deals with clinical research under the Clinical Trials Directive – the law repealed by the Clinical Trials Regulation – has been updated. During the first year of transition to the Regulation, sponsors have the option of applying for approval under the Directive, and they can continue trials under that regime until 31 January 2025.

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New course on sales and marketing released

Thu 25 Nov 2021 @ 17:42

grapl ltd, owner of the Zenosis library of eLearning for the medicines and healthcare products industries, is delighted to announce the release of a new course on sales and marketing: Marketing of Prescription Drugs in the USA — Interactions with Healthcare Professionals.

The heaviest legal penalties imposed on drug companies concern interactions with healthcare professionals in the context of prescription drug marketing, notably for violations of the Anti-Kickback Statute and the False Claims Act. Monetary penalties have amounted to billions of dollars in some cases.

Payments or other transfers of value made to certain healthcare professionals or teaching hospitals must be reported to the government. In addition, company-sponsored speaking programs and detailing by sales representatives must comply with provisions of the Federal Food, Drug, and Cosmetic Act on advertising and promotion. Industry guidance urges drug companies to follow the highest ethical standards as well as all legal requirements. This course identifies the laws and guidance that apply, and provides information that will help companies to market their products without incurring penalties.

Sales representatives and marketing personnel need to understand the legal and regulatory requirements that must be met, and the industry guidance that applies, when interacting with healthcare professionals in the context of marketing of prescription drugs in the USA. In addition, this module will be of benefit to regulatory affairs and legal personnel involved with aspects of marketing.

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New suite of courses on sales and marketing released

Thu 23 Sep 2021 @ 8:24

grapl ltd, owner of the Zenosis library of eLearning for the medicines and healthcare products industries, is delighted to announce the release of a new suite of courses on sales and marketing.

The industry has suffered massive monetary penalties imposed for breaches of legal and regulatory requirements on the marketing of products. These new courses will help companies to avoid incurring such damaging sanctions.

The first three courses in this new suite deal with advertising and promotion of prescription drugs in the USA. These will be followed soon by a course on interactions with healthcare professionals.

Sales and marketing personnel need to understand the legal and regulatory requirements that must be met when advertising and promoting prescription drugs in the USA. In addition, the courses will be of benefit to regulatory affairs and legal personnel involved with aspects of marketing.

The courses are:

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New Validation Suite of Courses

Mon 22 Mar 2021 @ 13:25

grapl ltd, owner of the Zenosis library of eLearning for the medicines and healthcare products industries, is delighted to announce the release of a new suite of courses on validation of manufacturing equipment, services, systems and processes.

Validation is vitally important in the pharmaceutical, biotechnology, dietary supplement, and medical device industries. Regulatory authorities require documented evidence that manufacturing processes will consistently result in products meeting predetermined quality standards. The new suite of courses provides an introduction to validation, and practical advice on equipment commissioning and qualification, equipment cleaning validation, and computer systems validation.

All involved in the manufacture of medicines and healthcare products need to understand the principles and practice of validation, as set out in these courses. In particular, the courses provide essential learning for engineering, production, and quality management personnel in the pharmaceutical industry.

The courses are:

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