COURSE DESCRIPTION

• BASIC PRINCIPLES OF BIOSTATISTICS
• Aim of the course
  – To provide basic training in applied biostatistics in health sciences.
  Educational objectives of the course
  Upon successful completion of the course the student shall be able:
  – To know why biostatistics is used in Biomedical research
  – To estimate the parameters of a statistical model used in the
  design and conduct of a clinical trial
  – To formulate and conduct hypothesis testing and construct
  confidence intervals for population parameters
  – To interpret the results of statistical tests
  – To critically read papers published in biomedical journals for the correct use of statistical tests and the corresponding result interpretati

• BASIC PRINCIPLES OF BIOINFORMATICS I & II
• Use of bioinformatics in identifying and understanding the genetic basis of a disease, methods and tools used to interpret and analyze biological data
• Research methodology

• Basic principles for writing an original article, a systematic review with meta-analysis or a literature review. Method and tools for checking the credibility of sources and the value of scientific documentation in each thesis reference. Ethical violations both in research and in the preparation and publication of the paper. Selection of scientific journals for the publication, preparation for publication and scientific registration of papers.
• Introduction – categories of scientific work
• LITERATURE research and collection of material
• Original THESIS
• Critical reading of original publications
• Evaluation indicators and editors
• Academic PUBLISHING procedure
• Narrative review
• Systematic review and meta-analysis
• Thesis presentation

• Microarrays and gene expression analysis
• Principles of Molecular Genomics – Transcriptomics
• Molecular mechanisms of carcinogenesis and pharmaceutical inhibition of selected target cells for therapy
• Cell death – Apoptosis
• Genomic instability, telomere function and DNA repair in neoplasia: New therapeutic strategies towards pan-cancer and targeted tumor therapies
• Introduction to Metabolomics
• Immunological approaches to new drug development
• Molecular mechanisms of cytokine signal transduction – the Jak/Stat pathway
• Proteomics: past, present and future
• The role of the proteasome in cellular physiology: insight to the model of ageing and age-related diseases
• In silico drug discovery for better targeted therapies
• RNA metabolism: advanced dynamic study systems from the single molecule level to tissue expression
• Data Science: From the Human Microbiome to the Global Virome
• Vascular mechanics in cancer progression

• Defining the categories of pharmaceutical products
• Excipients-Polymer and Surfactants
• Basic Principles of Physical Pharmacy and Pharmaceutical Technology
• Stability of Pharmaceutical Formulations
• Liquid and Semi-Solid Pharmaceutical Forms – Pharmacopoeia Controls
• Solid Pharmaceutical Forms – Tablets – Capsules – PolymerIC Systems
• Pharmacopoeia controls for solid pharmaceutical forms
• Drug Absorption-distribution-Metabolism- SECRETION i & II
• Basic Principles of Pharmacokinetics
• Administration of medicines through the respiratory system
• Case study: drug development
• Transdermal administration of medicines
• Basic Principles of Biotechnology
• Vaccines
• Nanotechnology drug delivery systems
• Lipid drug delivery systems
• POLYMERIC drug delivery systems
• NanoMEDICINES in Clinical Practice

• PRECISION MEDICINE IN GREECE
• GENE THERAPY
• NETWORKS IN PRECISION MEDICINE/PHARMACOLOGY
• MULTI-OMICS IN PRECISION MEDICINE
• GENOMICS – TRANSCRIPTOMICS
• GENES IN EVERYDAY PRACTICE, PHARMACOGENOMICS AND PERSONALISED TREATMENT
• PRECISION DRUG DESIGN
• CREATION OF NEW DRUGS AND STUDY OF THEIR PROPERTIES

Creation of new drugs and study of their properties through machine learning methods (A.I)

• Preclinical development of new drugs: stages and regulatory FRAMEWORK
• REGULATORY FRAMEWORK FOR THE USE OF ANIMALS FOR SCIENTIFIC PURPOSES
• ETHICS AND CONDUCT IN THE USE OF LABORATORY ANIMALS
• BIOETHICAL CONSIDERATION OF CLINICAL TRIALS

Despite the undoubted benefits of clinical trials for the society as a whole, important ethical issues sometimes arise in their implementation (e.g. the relationship between the pharmaceutical industry and clinical trials, ensuring participation in clinical trials, the medicalisation of life, etc.). The course “Bioethical Considerations of Clinical Trials” highlights anthropological aspects of the ethical issues encountered in the implementation of clinical trials, such as the devaluation of the human person, and puts forward safeguards to protect the human person (ethical principles, ethics of responsibility). Course Objectives: Students verify the existence of ethical problems in clinical trials, become aware of the causes of such problems, understand the responsibility of conducting a clinical study and its testing with anthropological sensitivities,become familiar with basic principles of bioethical approach to clinical trials.

• DESIGN OF CLINICAL PROTOCOL – FORMULATION OF RESEARCH QUESTION

Probably the greatest difficulty in conducting clinical research lies in selecting a clinical question and shaping it into a research question that can be answered. The clinical research question/hypothesis for intervention or observational studies can be structured based on the following mnemonics: PICO for quantitative studies (Population- Intervention- Comparison-Outcome) and FINER, which is more generally applied (Feasible-Interesting- Novel-Ethical- Relevant). Clinical research is conducted according to a specific plan, defined by the clinical protocol. The clinical protocol is the heart of any research attempt that ensures that the procedures defined by the research proposal are conducted in a consistent and reproducible manner. The aims of this lecture are to present the challenges and how to compose a research question on the one hand, and to analyse the design of a clinical protocol according to the research question and to describe the key elements and parts thereof.

• PHASE 0 CLINICAL STUDIES – IV

The aim of this course is to familiarize the trainees with the basic principles and the definition of clinical studies; to learn what the purpose and reason for each phase of a clinical study is and how to select a sample in each of them; to be exposed to research methodology and develop skills to evaluate the results of clinical studies; to present examples of clinical studies and their impact on clinical practice.

• CLINICAL TRIALS IN SPECIAL POPULATION GROUPS

The aim of this course is to examine the specificities of trials conducted in special population groups, such as children, rare diseases patients and the elderly;  the legal framework in these cases and the appropriate procedures, especially in matters of consent; the reason why it is necessary to study such groups and the conditions that must be met before a clinical trial begins; the ethical parameters to be taken into account. After this course, students shall be able to identify such special groups and make an initial planning of the conditions for conducting such a trial.

• THE INSTITUTIONAL FRAMEWORK OF CLINICAL STUDIES IN GREECE AND THE EUROPEAN UNION AND THE ETHICAL BACKGROUND AND IMPLICATIONS

Clinical studies, as a sub-category of medical research and ultimately of medical practice, due to the direct intervention on the human body with at least doubtful or no positive results for the participant, render the existence of a specific legislative framework necessary. The aim of this lecture is to outline such institutional framework and to highlight the moral-ethical implications behind legislative choices. Informed consent, conditions for the participation of persons unable to consent, state control, weighing between the intended benefit and the expected risks, the scientific need for the ‘internationalization’ of clinical studies are only some of the issues that national, EU and international legislators are called upon to address. Having slight divergences in individual regulations but a common line on the essentials, the legal framework for clinical trials is rendered a question of balance between fundamental rights.

• PERIODIC AUDITS DURING THE CONDUCT OF CLINICAL STUDIES

What are periodic audits during the conduct of clinical studies, what is their purpose and their place in the Quality Control System during the development of new drugs (link to ICH-GCP)? – What are the differences between periodic audits and inspections by Regulatory Authorities? – What is examined at a periodic audit?- What are the types of periodic audits?- Procedures during the pre-audit period, during and after the Periodic Audit – Do’s and Don’ts – How do companies process the results of periodic inspections?

• ROLE, ORGANISATION & OPERATION OF CRO COMPANIES

CROs (Contract Research Organizations) are the main providers of support for Clinical Studies (CS) conducted by Sponsors (Pharmaceutical Companies, University Institutions etc.) in selected Research Centers (Hospitals,  Doctors- Researchers). Their role is multifaceted, as they are involved in a variety of activities in the life cycle of each CS, as an intermediary between Sponsor and Researcher, providing services and specialized expertise at all stages of the development of the pharmaceutical product. This training module aims to understand the organisation and function of CROs and the individual activities they undertake on behalf of Sponsors, with regard to the following requirements for documenting and conducting CSs: 1. CS Guidelines and Legislation; 2.CS Design and Documentation; 3. Research Center Selection and Approval Procedures; 4. Supervision of Participating Research Centers and Oversight of Required Procedures; 5. Data Management, Statistical Analysis and Final Report; 6. Internal Audits and Authority Inspections.

• CLINICAL RESEARCH AS A TOOL FOR DEVELOPMENT
• EVALUATION OF CLINICAL STUDIES FROM THE PERSPECTIVE OF THE PHARMACEUTICAL INDUSTRY

Clinical trials in humans are conducted to provide answers to questions such as: a. Does a treatment work? b. Does a treatment work better than other treatments? c. Does it have side effects? Clinical trials also provide important information about the cost-effectiveness of a treatment, the clinical value of a diagnostic test and how the treatment improves quality of life. Clinical trials are carried out in research centers and in many different countries. The geographical diversity of such centers helps to ensure that participants are representative of those who need and shall benefit from the new medicine. The most important factors in the selection of research centres are: Infrastructure b. Facilities and training c. Patient availability. The benefits of conducting Clinical Trials for the patients, the Economy and the National Health System and for Physician-Researchers are multiple. Clinical Trials are conducted in accordance with the Rules of Good Clinical Practice required by regulatory bodies to protect patient safety. To advance our knowledge in medicine, it is mandatory to balance the protection of the human rights of the individual taking part in a Clinical Trial with the need of the society for new treatments. Clinical research and clinical studies are governed by universally accepted and particularly strict scientific, ethical and moral principles as well as international and local laws to which all those involved in clinical studies must adhere. All of the above is ensured by a set of guidelines and directives. One of the most important issues likely to influence a patient’s decision to participate in a Clinical Trial is whether and how their safety and rights are safeguarded during participation. We refer to the decision to participate in a clinical trial which is freely taken following appropriate information about the nature of the trial, its importance, its consequences and the risks involved and must be in writing, properly documented and dated and signed. One of the most important parameters is that the patient should first be informed by his/her physician of all the information about the Study (rights, purpose of the Study, duration, required Procedures, contact Links) as stated in the Consent Form and should have the time to then freely decide on his/her participation and also to withdraw at any time as his/her consent is in no way binding. Compliance with all principles and legislation ensures the rights of patients.

• FROM LABORATORY TO CLINICAL PRACTICE: IMPLICATIONS AND CONCLUSIONS FROM NEGATIVE CLINICAL STUDIES

Developing new drugs is becoming progressively more difficult and costly, as the modern personalised approach to treatment requires understanding and therapeutic modification of complex biological pathways. On the other hand, the need to contain the cost of innovative medicines to health systems and the multiple price contraction that this entails often deprives valuable resources from basic and clinical research. In this modern environment, it is crucial to make optimal use of all research results, including clinical studies with negative results. Although in these the intended clinical outcome was not achieved, they may provide important information both in terms of the details of their design that may have influenced their outcome, and in terms of the basic biology and pharmacokinetic/pharmacodynamic properties of the molecules under investigation. Therefore, they may, at the very least, contribute to optimising future research and the expenditure of the necessary resources.

• GCP FUNDAMENTALS – GCP INSPECTIONS BY THE EOF/EMA

The educational objective of this talk is to develop the basic principles of Good Clinical Practice and how to ensure compliance with it on the part of the regulatory authority (EOF/EMA). In the first part, we shall delve into the guidelines regarding the conduct of clinical trials of drugs for human use, as well as the requirements for the authorisation of the production or importation of such products. In the second part, we shall delineate the regulatory framework for the control of compliance with the rules of good clinical practice through inspections by the competent body, either at national (EOF) or central (EMA) level, as regards the principles and procedures applied in the development of medicinal products and clinical research, the applicable Community and national legislation and the guidelines applicable when conducting clinical studies.

• REAL WORLD TRIALS: IMPORTANCE AND NECESSITY
• BASIC PRINCIPLES FOR CONDUCTING CLINICAL RESEARCH FROM THE PERSPECTIVE OF THE NATIONAL ORGANIZATION FOR MEDICINES (EOF)
• DECENTRALISED CLINICAL STUDIES: INSTITUTIONAL FRAMEWORK, NECESSITY AND IMPLEMENTATION
• THE ROLE AND RIGHTS OF PATIENTS IN THE CONDUCT OF CLINICAL TRIALS
• GENE AND CELL THERAPIES: WHAT THEY ARE AND WHAT CHANGES IN CLINICAL TRIALS

• INTRODUCTION TO CLINICAL EPIDEMIOLOGY – PHARMACOEPIDEMIOLOGY-CLINICAL PHARMACOLOGY
• PRINCIPLES OF PHARMACOTHERAPY PRESCRIPTION AND FUNDAMENTAL CONDITIONS
• PHARMACODYNAMICS AND DRUG INTERACTIONS
• GENOMICS, BIOSIMILARS, NANO-SIMILARS: PHARMACOVIGILANCE AS A TOOL TO SAFEGUARD PUBLIC HEALTH

This lecture includes reference to three (3) categories of copy therapeutic products which belong to the categories of generic, biosimilar and nano-similar. Each category has its own regulatory and approval framework, which is in place, or under consultation to date, as in the case of nano-like therapeutic products. Also Pharmacovigilance which is related to the safe use of therapeutic products both in clinical practice and during clinical trials is an important topic of the lecture. The educational objective of the lecture is for students to become familiar with terminology related to both the scientific and regulatory rationale for the approval of generic and biosimilar therapeutic products , but also to understand the scientific difficulties of developing nano-similars and consequently the impossibility of creating a regulatory framework for their approval.

• COLLECTION & ANALYSIS OF SAFETY DATA IN CLINICAL TRIALS ,CLINICAL TRIAL SAFETY DATA REPORTING OBLIGATIONS, CONSEQUENCES OF BREACHES OF GOOD CLINICAL PRACTICE AND PATIENT SAFETY. RESPONSIBILITIES OF RESEARCHERS AND R&D DEPARTMENT HEADS
• PROTOCOL DESIGN, ETHICAL REQUIREMENTS, QUALITY STANDARDS AND GUIDELINES IN THE EUROPEAN UNION – ENCEPP- FOR PHARMACOEPIDEMIOLOGICAL RESEARCH
• DRUG SAFETY PA STUDIES
• DRUG SAFETY – EVALUATING BENEFITS VERSUS RISKS IN RESEARCH & DEVELOPMENT AND DURING THE DRUG CIRCULATION
• PHARMACOVIGILANCE, LEGISLATION, AWARENESS AND ACTIVE PARTICIPATION OF HEALTH CARE PROFESSIONALS AND PATIENTS
• NOTIFICATION OF ADVERSE DRUG REACTIONS: REPORTING AND MONITORING
• COURSE 14: CARE AND HEALTH SYSTEMS IN GREECE AND EUROPE
• COURSE 15: SOCIAL DIMENSION OF PHARMACY
• PREPARATION OF DIPLOMA THESIS

Το μάθημα εστιάζει στο ρυθμιστικό πλαίσιο που διέπει την ανάπτυξη και την κυκλοφορία νέων φαρμακευτικών προϊόντων σε ευρωπαϊκό και διεθνές επίπεδο. Οι φοιτητές γνωρίζουν τις βασικές αρχές και τις απαιτήσεις που θέτουν οι αρμόδιες ρυθμιστικές αρχές όπως ο ΕΟΦ, ο ΕΜΑ και ο FDA, καθώς και τις διαδικασίες αξιολόγησης που αφορούν την έγκριση και την εποπτεία φαρμάκων.

Στο επίκεντρο της διδασκαλίας βρίσκονται θέματα όπως η ανάπτυξη βιοομοειδών και γονιδιακών θεραπειών, οι ιδιαιτερότητες των μετεγκριτικών μελετών, καθώς και η εξέλιξη των ρυθμιστικών απαιτήσεων για ιατροτεχνολογικά προϊόντα και συσκευές τύπου portable. Μέσα από εισηγήσεις από ειδικούς του χώρου και εκπροσώπους της φαρμακοβιομηχανίας, προσφέρεται μια σύγχρονη και ρεαλιστική προσέγγιση στον τρόπο με τον οποίο εφαρμόζεται στην πράξη η φαρμακευτική πολιτική και η κανονιστική συμμόρφωση.

Το μάθημα ενισχύει την κατανόηση του ρόλου των ρυθμιστικών αρχών στην προάσπιση της δημόσιας υγείας και προετοιμάζει τους φοιτητές για την ενεργή συμμετοχή τους σε όλα τα στάδια του κύκλου ζωής ενός φαρμάκου, από την ανάπτυξη έως την παρακολούθησή του μετά την κυκλοφορία.

• HEALTH TECHNOLOGY ASSESSMENT (HTA): BASIC PRINCIPLES, GRADE SYSTEM, APPLICATION OF ASSESSMENT

Drug price determination, European drug pricing and reimbursement systems, pricing strategies, new products, orphan drugs, pricing and reimbursement in Greece, basic
negotiation techniques

• Fundamentals, strategy, communication plan – digital era,
  public awareness campaigns, patient compliance programmes, etc.
• DIGITAL MARKETING IN THE PHARMACEUTICAL MARKET
• The environment in which we operate is constantly changing with digital technologies playing a catalytic role in the pace of evolution. Our behaviour as consumers
  is changing, healthcare professionals are being equipped, patients are being empowered and of course marketing is being transformed.
  This of course directly affects the pharmaceutical market. Digital medical information channels are proliferating, the way they interact is evolving and their importance is growing.
  In this lecture we shall navigate from the importance of content to the patient journey, to increasing a website’s traffic, from social media algorithms, to enhancing word of mouth, from instant messaging to virtual assistants, from emotional to artificial intelligence and from digital to

  Modern digital media create rapid developments, new conditions and sometimes delicate balances with the past. But one thing is certain. The future – like the present –
  in communication, information and education is not what it used to be!

Educational objective: To understand the data, media and practices of multichannel communication and medical information in the digital age
To present the basic principles of effective
interaction in digital marketing
To guide participants in the application of new
digital media and practices in the healthcare environment

• THE USE OF MARKET RESEARCH IN PHARMACEUTICAL MARKETING

Types of market research, characteristics of each type, advantages and disadvantages

• Possibility of using market research in the different stages of a drug’s development: research, launch, access
• Examples of using market research in the research stage
• In assessing the global sales dynamics of potential products in order to prioritise (or not) their development
• Examples of using market research in the launch stage
• In the initial stages of launching the drug to the market
• In the assessment of health technologies
• In the comprehension of the opinions of the payers and health executives on issues of pricing and reimbursement.
• In the comprehension of the patients’ and broader public opinions on issues of pricing, acces and participation of patients to the drug purchase.
• INTRODUCTION TO PHARMACEUTICAL MARKETING-STRATEGIC MARKETING, PRODUCT POSITIONING- PHARMACEUTICAL MARKETING IN THE ERA OF COVID

Pharmaceutical marketing, although based on the classical principles of marketing science, differs significantly due to the sensitive subject of health, the strict institutional framework and the complex nature of the pharmaceutical “market”, in which the “customers” (doctors) are usually different from the “consumers” (patients).Scientific data are the basic material for the differentiation of pharmaceutical preparations. The aim of pharmaceutical marketing is to investigate the needs of customers and to ensure that scientific data are correctly understood and interpreted. In its modern evolution, pharmaceutical marketing is not limited to the pharmaceutical ‘product’ but focuses on the whole range of patient care and benefits. ‘Positioning’ summarises the main benefits that differentiate the product from competing products and identifies the target market ‘Strategic imperatives’ extend beyond the simple differentiation of the product. ‘Strategic imperatives’ extend beyond the simple differentiation of the product including areas of scientific education, public awareness of the disease, as well as issues of patients’ access to treatment. ‘Marketing Mix’ of a pharmaceutical product also extends beyond the ‘product’ itself to issues relating to the whole of patient care. The aim of this training is to convey the basic principles of pharmaceutical marketing, through a focused approach that can be understood by both trainees who are familiar with the pharmaceutical sector and those who are approaching it for the first time. The first part of this training is to provide a comprehensive overview of the principles of pharmaceutical marketing, including the scientific principles of marketing, the scientific principles of the product, the scientific principles of patient care and the principles of access to treatment. Particular emphasis is placed on the recent developments due to COVID-19 and the expected impact after the pandemic. The basic principles of Strategic Marketing are then analysed, with a particular focus on pharmaceutical product strategy and pharmaceutical market research. Finally, the concepts and different types of positioning and differentiation of pharmaceutical products are analysed.

Assessment of drug value, basic principles of health economic evaluation, cost & effectiveness correlation
– cost minimisation, impact analysis, early economic
models

• THE CONCEPT OF THE THERAPEUTIC VALUE OF THE MEDICINAL PRODUCT. IS THERE AN AGREEMENT?

The lecture aims to understand the concept of the “therapeutic value” of medicines and how this is interpreted according to the context of use and the recipients of the communication. The absence of a commonly accepted definition has resulted in patients, healthcare professionals, regulators and payers perceiving this concept differently. But how can we assess ‘value’ if we do not agree on its definition?

• REGULATORY FRAMEWORK FOR THE EVALUATION OF PHARMACEUTICALS IN EUROPE AND GREECE: FROM APPROVAL TO PRICE NEGOTIATION

The content of the lecture is the presentation of the historical context of the creation of the health technology evaluation mechanism in Greece and the assessment committee, the work performed by the committee, the administrative procedures for the evaluation and reimbursement of drugs as well as the scientific criteria for their assessment.

The educational objective of the course is to enable students to understand how the evaluation and reimbursement process for medicinal products for human use in Greece is organised and how it is linked to the process of negotiating the reimbursement price of pharmaceutical products the Marketing Authorization Holders (MAHs) of which apply to be included in the list of reimbursed medicinal products.

• ADDED THERAPEUTIC VALUE OF NEW MEDICINES – CLINICAL EFFECTIVENESS AND RELIABILITY OF CLINICAL DATA

The educational objective of the lecture is to describe the methodology used to assess the clinical effectiveness of drugs, the quality of clinical trial data and the reliability of clinical outcomes. The lecture presents the current situation regarding patient access to new therapies and the main clinical criteria for evaluating new drugs, such as disease severity and burden of disease, their impact on mortality/morbidity rates, safety data and comparison with already available therapies. The importance and prioritisation of study endpoints and the relevance of clinical trial results to clinical practice shall be extensively discussed. In addition, ways of calculating the magnitude of clinical benefit from cancer therapies using the ESMO-Magnitude of Clinical Benefit Scale as an example will be presented. Finally, the GRADE methodology according to which the degree of reliability of clinical trial data is defined shall be described.

• QUALITY OF LIFE AND PATIENT REPORTED OUTCOMES (PROS)

The educational objective of the lecture is to describe the category of outcomes known as “patient-reported outcomes” (PROs) and their importance for decision-making in the health care sector and patient access to new treatments. The lecture will discuss the definitions of PROs, patient quality of life and health-related quality of life and how they are used in the assessment of health technologies by different organisations. The lecture shall provide an overview of the methodological issues that need to be considered when using PROs to illustrate the key points related to the reliability and validity of the results. In addition, the advantages and limitations of PROs shall be discussed, as well as ways in which data collection and analysis can be optimised to make better use of the data.

• BENEFIT/RISK ASSESSMENT FRAMEWORK: QUALITATIVE AND QUANTITATIVE APPROACHES
• THE GUIDELINES OF EMA, FDA AND OTHER INTERNATIONAL ORGANISATIONS ON RISK-BENEFIT ASSESSMENT AND THE PRACTICAL APPLICATION IN GREECE
• THE CHALLENGING PATH TO ACCESS TO INNOVATION – EARLY ACCESS TO INNOVATION

The treatment of diseases with modern therapeutic and diagnostic tools has improved tremendously in recent decades. Despite the unimaginable advances in technology, however, the path that a molecule, a simple chemical compound, or a complex biotechnological therapy takes from its discovery to being safely made available for patient relief remains complex, time-consuming and difficult. Access of patients with unmet medical needs as quickly as possible while ensuring as much safety as possible is an absolute priority for society. New methods of research and development, new technologies and even artificial intelligence are now available to us in this fight. In this course we shall analyze in depth the path of clinical research and access to innovative treatment in our country.

• ECONOMIC EVALUATION OF NEW PHARMACEUTICALS AND ITS ROLE IN ACCESS DECISIONS

In this section we shall present and analyse issues related to:

1. The pharmaceutical innovation environment
2. The contribution of new medicines and the concerns about:
   • the rate of entry into health systems,
   • their price,
   • the necessity of their economic evaluation and the methods used in health economics
   • their reimbursement

• DISEASE COST ANALYSES AND CHALLENGES IN COST ASSESSMENT

In this section we shall present and analyse issues related to:

1. Cost categories in the economic evaluation of medicines
2. Cost determination perspective
3. Identification and components of costs

• BUDGET IMPACT ANALYSIS AND NEGOTIATION

The analysis of the budgetary impact of reimbursing a new treatment is an integral part of the evaluation of a health technology for the purpose of deciding whether or not to reimburse it. The lecture discusses the technicalities of this analysis in order to prepare the context in which the negotiation of reimbursement terms between the marketing authorisation holder and the payer shall take place. The aim of the analysis and negotiation should be to ensure that patients have access to value-added treatments on terms that ensure the sustainability of the health care system.

• PATIENT REGISTRIES AND REAL WORLD DATA. THEIR ROLE IN ACCESS.

The decision-making process for designing health services and optimising the coverage of population needs must be based on data that describe the actual health status of the population and that reflect the impact of programmes, treatments and other decisions on general or specific populations. The purpose is to define the framework for the administration of medicines and to improve patient access to new treatments through a process of continuous evaluation and renegotiation of reimbursement terms based on their actual therapeutic value for the reference population.

Principles of health policies in Greece, in Europe, comparative data, decision making, health policy institutions