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Masters Degrees (Pharmacoeconomics)

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Programme description. Over the last 30 years healthcare research and drug development have been transformed from peripheral activities carried out on an ad hoc basis to a core activities that requires trained, professional, staff. Read more
Programme description
Over the last 30 years healthcare research and drug development have been transformed from peripheral activities carried out on an ad hoc basis to a core activities that requires trained, professional, staff. We have developed a modular postgraduate programme in healthcare research, designed to give you the necessary academic background and specialist skills to carry out healthcare research in a contract research organisation, pharmaceutical industry or health service environment.

If you are a graduate, nurse, medical doctor or other health professional working in contract research organisations, the pharmaceutical industry and healthcare, this programme has been designed for you.

Programme outline
This postgraduate programme share a common spine with our Clinical Drug Development programme, which also covers the key areas of expertise needed for a successful clinical research programme. The Healthcare Research Methods programme places an emphasis on health management.

The modular nature of the programme is designed to fit in with full-time employment. The taught elements of the modules are delivered in three-day blocks every six weeks.

Core modules

Clinical Study Design
Practical Aspects of Clinical Research and Early Drug Development
Ethics and Regulation
Data Management and Statistics
Specific Topics in Clinical Trial Design
Elective Dissertation
Health Outcomes and Pharmacoeconomics
Marketing Healthcare
Research Project/Dissertation
Health and the Human Body
Healthcare Organisation and Decision-Making
Module options include:

Drug Discovery and Preclinical Research and Development
Toxicology

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Programme description. Over the last 30 years healthcare research and drug development have been transformed from peripheral activities carried out on an ad hoc basis to become core activities that require trained, professional, staff. Read more
Programme description
Over the last 30 years healthcare research and drug development have been transformed from peripheral activities carried out on an ad hoc basis to become core activities that require trained, professional, staff.

We have developed a modular postgraduate programme in clinical drug development designed to give you the necessary academic background and specialist skills needed to carry out clinical drug development in a contract research organisation , pharmaceutical industry or health service environment.

If you are a nurse, medical doctors or other health professionals working in contract research organisations, the pharmaceutical industry and healthcare, this programme has been designed for you.

Programme outline
This postgraduate programmes shares a common spine with our Healthcare Research Methods programme, which covers the key areas of expertise needed for a successful clinical research programme.If you choose the Clinical Drug Development programme, your initial modules will concentrate on early drug development.

The modular nature of the programmes is designed to fit in with full-time employment. The taught elements of the modules are delivered in three-day blocks every six weeks.

Core modules:

Clinical Study Design
Practical Aspects of Clinical Research and Early Drug Development
Ethics and Regulation
Data Management and Statistics
Specific Topics in Clinical Trial Design
Elective Dissertation
Health Outcomes and Pharmacoeconomics
Marketing Healthcare
Research Project / Dissertation
Drug Discovery and Pre-clinical Research and Development
Toxicology
Module options include:

Health and the Human Body
Healthcare Organisation and Decision Making

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-A work based practical programme of study which builds on and allows application of knowledge gleaned during the Certificate in Psychiatric Therapeutics. Read more
-A work based practical programme of study which builds on and allows application of knowledge gleaned during the Certificate in Psychiatric Therapeutics
-The qualification is often a requirement for specialist mental health pharmacist posts in the NHS
-Written, taught and assessed by specialist mental health pharmacists

Course outline

Practice-based clinical modules:
-Introduction to Clinical Practice
-Clinical Interventions
-Formulary Development, Clinical Audit and Communication

Compulsory knowledge based components:
-Psychological Therapies
-Substance Misuse
-Evidence Based Medicine and Information Technology
-Pharmacoeconomics

Plus a choice of two from the following four:
-Research Methods
-Learning Disabilities
-Child and Adolescent Psychiatry
-Epilepsy

Learning, teaching & assessment

The range of learning methods will be used, including distance learning materials, directed reading, self assessed exercises, additional reading and participation in a multi disciplinary forum (MDT).

Assessment is by assignments, clinical proformas, oral case presentations and a final examination.

Career prospects

This qualification is often a requirement for specialist clinical mental health posts in the NHS.

“Specialist status” as deemed by Membership of the College of Mental Health Pharmacy is also increasingly expected for higher level clinical posts in the NHS. The Diploma forms part of the pathway for this accreditation.

Personal development

The following skills will be developed:
-Independent study
-Good time management
-Effective written communication
-Effective oral communication
-Effective information retrieval, organisation and presentation

Professional accreditation

The programme is supported by the College of Mental Health Pharmacists (CMHP).

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Humber’s Regulatory Affairs graduate certificate program focuses on developing the concepts, skills and techniques required to work in regulatory affairs in the pharmaceutical, medical device or biotechnology industries. Read more
Humber’s Regulatory Affairs graduate certificate program focuses on developing the concepts, skills and techniques required to work in regulatory affairs in the pharmaceutical, medical device or biotechnology industries. You will gain knowledge of the regulatory system, legislation, procedures and practices which relate to the development, manufacture, quality assurance and marketing of health-related products.

The importance of internationally harmonized regulations and future trends in the industry will be examined by analyzing relevant international and Canadian legislation and regulations. You will study a wide range of regulations and standards including good manufacturing practices, good laboratory practices, good clinical practices, good documentation practices, the International Organization for Standardization (ISO), the Canadian Food and Drugs Act, the Environmental Protection Act, principles of regulatory compliance and inspections, drug establishment licensing, and related standards and guidelines. Teamwork and communication skills are emphasized and you will acquire information technology skills that assist communication and data management specific to regulatory affairs.

You will become familiar with the steps necessary for product submission; how to assemble documents and statistical evidence; the complexity of product registration, negotiation and follow-up, and how these are linked to the federal government and provincial formularies.

Course detail

Upon successful completion of the program, a graduate will:
• Describe the government processes within the Canadian health care system and provincial formularies.
• Explain the roles and responsibilities of a regulatory professional in industry.
• Explain the concepts in pharmacoeconomics as they relate to the socioeconomic aspects of health care and health care products.
• Explain Canadian and international health care legislation and regulations including (as examples) Good Manufacturing Practices, Good Laboratory Practices, Good Clinical Practices, Good Documentation Practices, International Standards Organization (ISO), Food and Drug Act Regulations, the Environmental Protection Act, Regulatory compliance/inspection, Drug Establishment Licensing and related standards and guidelines.
• Describe international harmonization of regulations and the impact on manufacturing and the submission process.
• Explain the Product Development Process.
• Outline the Quality Control Process.
• Demonstrate information technology skills in the use of software applicable to regulatory affairs submissions, in document and database management systems, in data correction techniques and in the use of the Internet for research.
• Define drug (prescription and non-prescription)/medical device/biologic submission process requirements.
• Prepare a drug/medical device/biologic submission to the Therapeutic Products Program (TPP) including supplemental documentation.
• Demonstrate the problem solving process as it relates to pharmacovigilance and post-marketing surveillance.
• Demonstrate effective interviewing and negotiating skills in managing a clinical study.

Modules

Semester 1
• REGA 5020: Health Care Legislation, Regulation and Guidelines
• REGA 5021: Product Development-Premarket
• REGA 5022: Product Development-CMC
• REGA 5023: Medical Products Safety
• REGA 5024: Communication
• REGA 5025: Pathophysiology and Pharmacology

Semester 2
• REGA 5030: Management of Regulatory Submissions
• REGA 5031: Management of Global Regulatory Submission
• REGA 5033: Regulation of Food Products and Agrichemicals
• REGA 5034: Medical Devices
• REGA 5035: Provincial Formularies and Reimbursement Policy
• REGA 5036: Emerging Biotechnology

Semester 3
• REGA 5040: Internship
• REGA 5041: Integative Seminar

Work Placement

Following two academic course-based semesters, students complete a three-month placement that provides opportunities to apply and integrate theoretical knowledge and skills into real-world work settings. Most placements are in the following sectors: pharmaceutical, biotechnology, medical device organizations, government agencies or food industries.

Your Career

Our graduates work in a spectrum of fields such as pharmaceutics, biotechnology, medical devices, natural health product industries or in government.

How to apply

Click here to apply: http://humber.ca/admissions/how-apply.html

Funding

For information on funding, please use the following link: http://humber.ca/admissions/financial-aid.html

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