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11747 Professional Development courses delivered Online

SUB14: The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA

By Zenosis

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 Food and Drug Administration (FDA), have been established only in recent years.

SUB14: The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA
Delivered Online On Demand30 minutes
£99

VAL06: Computer Systems Validation, Part 1: Planning

By Zenosis

In the medicines and healthcare products industries, computerised systems used in automated manufacturing or laboratory processes to which Good Manufacturing Practice requirements apply need to be validated. This module describes the planning of such validation. It follows the work of a pharmaceutical company's team as they validate the dispensary control system for a new production line.

VAL06: Computer Systems Validation, Part 1: Planning
Delivered Online On Demand1 hour
£99

VAL07: Computer Systems Validation, Part 2: Implementation

By Zenosis

This module describes the design, development and installation phase, the validation phase, and the operation and maintenance phase of the validation of computerised systems in medicines and healthcare products manufacturing environments. It continues to follow the progress of a pharmaceutical company's project to validate a new dispensary control system.

VAL07: Computer Systems Validation, Part 2: Implementation
Delivered Online On Demand1 hour
£99

SUB13: How to Gain Approval to Market a Generic Drug in the USA

By Zenosis

This module 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 ‘Orange Book’ 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 FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.

SUB13: How to Gain Approval to Market a Generic Drug in the USA
Delivered Online On Demand3 hours
£99

Understanding Workplace Bullying and Harassment (In-house)

By Conduct Change Ltd

Understanding Workplace Bullying and Harassment The definitive guide to workplace bullying & harassment delivered by UK's leading expert.


 Understanding Workplace Bullying and Harassment (In-house)
Delivered OnlineFlexible Dates
£1500

Business Analysis: Market Research Analyst

5.0(2)

By Studyhub UK

Business Analysis: Market Research Analyst
Delivered Online On Demand9 days
£315

A Practical Guide through Business Analysis

5.0(2)

By Studyhub UK

A Practical Guide through Business Analysis
Delivered Online On Demand9 days
£315

Change Management: Leadership, HR, Recruitment & Employment Law - 30 Courses Bundle

By NextGen Learning

Change Management: Leadership, HR, Recruitment & Employment Law - 30 Courses Bundle
Delivered Online On Demand5 days
£199

SUB11: The Decentralised Procedure (DCP)

By Zenosis

This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the DCP.

SUB11: The Decentralised Procedure (DCP)
Delivered Online On Demand2 hours
£98

CT08: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure

By Zenosis

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.

CT08: Clinical Trial Monitoring: Study Monitoring, Documentation and Closure
Delivered Online On Demand2 hours
£98