10638 Professional Development courses in Ryde delivered On Demand

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.

To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (i.e. medicines regulator), and favourable opinion must be obtained from a research ethics committee, in each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.

An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation, filing and maintenance of INDs. The IND and its role are defined, and the contexts in which it is required are specified.

Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.

Learning Agility as the New Differentiator for Managing Projects at Today's Pace of Change Levers of Project Agility: Effective Sponsorship You may be using agile processes in your projects, even have extended the use of agile management practices into other areas of business. However, lack of purposeful and appropriate sponsorship can stifle most projects. An under-engaged or over-enthusiastic sponsor can demotivate the team, slowdown decision making and disrupt even best agile processes. In this talk, we will examine the crucial role of the sponsor, their desired attributes and their relation with the project manager, product owner and scrum master to identify the risk factors and provide tips and tools for avoiding pitfalls and having effective sponsors. You may be agile, but a poor sponsor can still hamper project success. We'll examine this crucial role, ideal attributes, and provide tips to maximize sponsor effectiveness. This and other IIL Learning in Minutes presentations qualify for PDUs. Some titles, such as Agile-related topics may qualify for other continuing education credits such as SEUs, or CEUs. Each professional development activity yields one PDU for one hour spent engaged in the activity. Some limitations apply and can be found in the Ways to Earn PDUs section that discusses PDU activities and associated policies. Fractions of PDUs may also be reported. The smallest increment of a PDU that can be reported is 0.25. This means that if you spent 15 minutes participating in a qualifying PDU activity, you may report 0.25 PDU. If you spend 30 minutes in a qualifying PDU activity, you may report 0.50 PDU.

Level 4 QLS Endorsed Course with FREE Certificate | CPD & CiQ Accredited | 120 CPD Points | Lifetime Access

Free Level 7 QLS Endorsed Certificate | CPD Accredited | 180 CPD Points | Advanced Learning Materials | Lifetime Access

Level 7 QLS Endorsed Course with FREE Certificate | CPD & CiQ Accredited | 180 CPD Points | Lifetime Access

Level 4 QLS Endorsed Course with FREE Certificate | CPD & CiQ Accredited | 120 CPD Points | Lifetime Access

Free Level 5 QLS Endorsed Certificate | CPD Accredited | 150 CPD Points | Advanced Learning Materials | Lifetime Access