7448 Medicine & Nursing courses in Cardiff delivered Online

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.

Level 5 - Three QLS Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 10 CPD Courses | Lifetime Access

Level 5 - Three QLS Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 10 CPD Courses | Lifetime Access

Portfolio, Programme, and Project Offices (P3O®) Practitioner: In-House Training P3O® is the AXELOS standard for the design of decision-making processes regarding changes in organizations. P3O provides a guideline for the design of portfolio, programme, and project offices in organizations. The P3O Practitioner Course is an interactive learning experience. The P3O Practitioner-level content provides you with sufficient knowledge and understanding of the P3O guidance to design, implement, manage or work within any component office of a P3O model. It enables participants to successfully complete the associated P30 Practitioner exam and achieve the qualification. In this course, you will be prepared to successfully attempt the P3O Practitioner exam and learn how to implement or re-energize a P3O model in their own organization. What you will Learn At the end of the P3O Practitioner course, you will be able to: Define a business case to get senior management approval for P3O Build a right P3O model to adapt to the organization's needs, taking account of the organization's size and portfolio, programme and project management maturity Identify the elements, roles, and functions deployed in a generalized P3O model Use tools and techniques in running the P3O and advising those who shape the portfolio of programmes and projects Introduction to P3O What is the purpose of P3O? Definitions What are P3Os? Portfolio, programme, and project lifecycles Governance and the P3O Designing a P3O Model Factors that affect the design Design considerations What functions and services should the P3O offer? Roles and responsibilities Sizing and tailoring of the P3O model Why have a P3O? How a P3O adds value Maximizing that value Getting investment for the P3O Overcoming common barriers Timescales Why have a P3O (Extension)? The P3O Business Case The P3O Model Blueprint Vision Statement Demonstrating the Value KPIs The Benefits of Claimed Capabilities Benefit Realisation and Strategic Objectives Benefit Profile How to Implement or Re-Energize a P3O Implementation lifecycle for a permanent P3O Identify Define Deliver Close Implementation lifecycle for a temporary programme or project office Organizational context Definition and implementation Running Closing Recycling How to operate a P3O Overview of tools and techniques Benefits of using standard tools and techniques Critical success factors P3O tools P3O techniques

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Level 4 QLS Endorsed Course | Endorsed Certificate Included | Plus 5 Career Guided Courses | CPD Accredited

CPD Certified | 10-in-1 Pharmaceutical Diploma| 1 Free PDF Certificate| 24/7 Learner Support