Learning Outcomes:

6a  Understand where patients can apply these to the HTA process and formulary decision in their country

6b  Outline the difference between quantitative and qualitative research

6c  Understand the role each type of research plays in HTA

6d  Understand the principles, practical application and importance of patient reported outcomes in developing the evidence

6e  Understand how this additional evidence can be used in HTA processes

6K  Understand what ‘good’ economic evaluation looks like

6L  Understand what ‘good; ethical, legal and social implications (ELSI) analysis looks like

6M  Locate key reference sources for comparing features of health system reimbursement

6N  Comparisons across two systems

6O  Understand what type of information contributes to a better understanding of clinical benefit (e.g., randomized trials)

6P  Understand differences in clinical information requirements for patients, payers, and regulators

6Q  Understand rigorous methods for identifying and combining information (e.g., systematic review and meta-analysis)

6R  Understand the strengths and weaknesses of methods to combine data

6S  Identify the main HTA agencies in Europe

6T  Understand their different approaches to evaluating medicine and health technologies

6U  Understand the role of evidence-based medicine and how this relates to HTA in European agencies

6V  Describe specific opportunities for patients in key agencies across Europe

6W  Describe the concepts of quality of life, health-related quality of life, and patient-relevant outcomes

6X  Understand how these are measured

6Y  Describe how these can be incorporated into HTA assessments

6Z  Understand the principles, practical application and importance of patient reported outcomes in developing the evidence for

Learning outcomes module 5:

5A  Critically review the current EU regulatory requirements (pre and post-authorisation) for a medicinal product

5B  Critically evaluate the pharmacovigilance of a medicinal product and the role of the various stakeholders

5C  Discuss the various aspects of shortages of medicines and the role the different stakeholders

5D  Discuss the role and importance of Regulatory Agencies and other stakeholders in particular patients/patient organizations throughout the lifecycle of a medicinal product

5E  Describe the provisions of (1) off label use (2) compassionate use and (3) controlled medicinal products at a national and EU level

5F  Outline the legislative background and review processes product information

5G  Explain the role of different organizations in the development and implementation of regulatory legislation in Europe

5H  Critically discuss treatment compliance and comprehension

5I  Locate and navigate regulatory agencies’ websites and sources of information on medicinal product interactions

As an independent contractor, it can be hard to work in a new system remotely off site. This training course is designed to walk you through how to put your interpretation and medication breakdown into the system.

Learning outcomes module 4:

4A  Outline the key strategic and operational issues in the clinical trial process, including legal, regulatory, & practical aspects and the possibilities of collaboration of different stakeholders

4B  Appraise the principles and practical relevance of ethics in clinical research and the role patients can play e.g in ethics committees

4C  Explain and demonstrate the clinical trial approval process including the required documentation and the possible role of Patients/POs and provisions for special/vulnerable patient populations

4D  Describe the main statistical methods used in clinical research

4E  Critically evaluate the concept of benefit-risk, the collection, evaluation and reporting of adverse event data and risk management in clinical trials and the various roles patient can play

4F  Describe the principles of data management and the associated study documentation and quality measures in clinical trials

4G  Appraise the relevant aspects of patient compliance for study medication including its labelling, handling

4H  Critically evaluate the content of clinical trial websites and their use in identification of trials in your disease area. (Including reporting of adverse events)

4I  Differentiate types of clinical trials and their design, and Good Clinical Practice (GCP)

4J  Discuss all aspects of the interpretation, publication and communication to patients of all clinical trial results

Learning outcomes module 1:

1A:  Explain the importance and describe the possible role of patients/patient organizations in medicines development

1B:  Describe the process of drug discovery and development and identify the critical factors and decision points, including patenting, and drug development in special populations

1C:  Describe the background to the development of regulation of medicines and the roles of the various stakeholders

1D:  Discuss the role of biomarkers in drug development

1E:  Discuss the potential application of the concept of personalized/stratified medicine in the medicine development process

1F:  Discuss the role of translational research in drug development

1G:  Outline the concepts of evidence based medicine and outcomes research

1H:  Describe predisposing factors and underlying mechanisms of disease and the different types of medicines and their mode of action

Learning outcomes module 2:

2A: Illustrate the choice and predictive value of the non-clinical testing programme as part of the overall medicine development plan (including scheduling of toxicology tests with respect to clinical trials).for chemical and biological compounds

2B:  Describe the non-clinical development steps of medicines, explain the milestones a compound needs to go through during non-clinical development in order to progress to the next phase

2C:  Illustrate non-clinical outcomes that can stop the development of a medicine

2D:  Discuss the need and requirements for pre-clinical studies prior to First-in-Man studies and the purpose of animal testing. (including toxicology, pharmacology, non-clinical safety studies )

2E:  Outline the steps in the medicinal development of a medicines substance and final medicines product (including chemical and biological compounds)

2F:  Based on the understanding of the blinding process, Identify ways in which you as patient advocate can contribute to the choice of blinding mechanisms

2G:  Outline differences in generic development vs. classical drug developments

2H:  Describe guidelines for the use of generics

Learning outcomes module 3:

3A    Define intended therapeutic indication, its limitations and criteria for “go” “no-go” decisions and its final description

3B    Describe the early clinical development plan and clinical study types (phases) and their objectives beginning with “first in human” and the different ways in which Patients/POs can contribute

3C    Critically appraise the role of pharmacogenetics / pharmacogenomics in the development of medicines and discuss the ethical challenges

3D    Outline the basic principles of pharmacokinetics and their application to dose-finding and in subsequent phases of drug development

3E    Define Life Cycle Management of a medicine, its purposes and possible approaches via post marketing trials

3F    Evaluate and compare the emerging techniques in specific product development or disease areas

3G    Discuss the advantages and critical aspects of global coordination / harmonisation of clinical trial programmes before and after marketing authorisation