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PRESENTATION

The Centre for Evidence Based Medicine (CEMBE) is a structural unit of the Faculty of Medicine, University of Lisbon created with the aim of spreading the principles of Evidence-Based Medicine.

The CEMBE-HEALTH is the interface between the university and the society for the provision of consultancy services in health and medicine. Since 1999 CEMBE-HEALTH has established partnerships and created solutions in the field of life sciences for public and private national and international entities.


CONTACTS

@: cembe@medicina.ulisboa.pt
P: +351 217 940 424

Address:
CEMBE
Faculdade de Medicina da Universidade de Lisboa
Av. Prof. Egas Moniz
1649-028 Lisboa


VISION

To be recognized as a center of excellence in the production of high quality information on health systems that will translate into added value for the different public or private agencies.

MISSION

Production of independent scientific knowledge, relevant and of high quality, for decision support in clinical areas, management and administration, the definition of evidence-based health policies and increase in health literacy of patients and consumers.

VALUES

Independence | Rigor | Knowledge | Excellence | Experience | Responsibility| Efficiency

MANAGEMENT BOARD

ANTONIO VAZ CARNEIRO, MD, PhD, FACP, FESC
Director
Specialist in Internal Medicine, Nephrology and Clinical Pharmacology
Director, Department of Medical Education and of the Library, Center for Information and Documentation
Faculty of Medicine, University of Lisbon
Director, Cochrane Portugal

JOÃO COSTA, MD, PhD
Deputy Director
Specialist in Neurology, Neurophysiology and Clinical Pharmacology
Professor of Therapeutics and Clinical Pharmacology
Faculty of Medicine, University of Lisbon
Coordinator of the Portuguese Branch of the Iberoamerican Cochrane Network
jncosta@medicina.ulisboa.pt

MARGARIDA BORGES, MD
Deputy Director
Specialist in Pulmonary Diseases
Director of the Clinical Pharmacology Service at the Central Hospital of Lisbon, EPE.
margarida.borges@medicina.ulisboa.pt

PROFESSIONAL AREAS OF CEMBE

I. Registration, selection and evaluation of drugs

The main objectives of drug registrations are to ensure the quality, effectiveness and safety of drugs marketed in the country, ensuring their availability and accessibility to the entire population.

The evaluation of medicines and other health technologies is a key instrument to support health decision-making process. It covers not only the procedures for assessing therapeutic and economic value, but also the social impact of the disease or condition for which the drug is indicated, in order to define priorities, the size and severity of policy problems, and developing strategies and priorities.

Marketing authorization (MA)

• Preparation, submission and management of MA requests
• Preparation of specific sections of a MA registration dossier (quality modules, pharmaco-toxicology/pre-clinical studies, efficacy/clinical trials)
• Preparation, translation and review of public drug documentation (summary of product characteristics, prospectus and packaging)
• Conducting readability testing of leaflets

Maintenance of the drug in the marketing

• Preparation and submission of changes and renewals of MA
• Price requests
• Financing mechanisms
• Detection of adverse reactions, registration and evaluation systems (pharmacovigilance)

Consulting

• Advice on strategy and regulatory requirements
• Developing strategies for price and financing
• Technical evaluation of documents/data
• Technical/scientific translations
• Research/literature reviews
• Drug quality control

Drug evaluation and other health technologies

• Technical and scientific assessments of added therapeutic value
• Economic evaluation studies
• Budget impact studies
• Disease burden and cost studies
• Consensus conferences
• Market acess

 Building expert panels

 

II. Health governance

Clinical governance

Clinical governance can be seen as a system that allows one to develop organizational capabilities to offer quality and sustainability health care, and is focused on the patient. One of the fundamental basis is the provision of relevant and updated scientific knowledge.


Clinical practice guidelines

Clinical practice guidelines are a tool to support medical-decision making in order for health professionals to deliver the highest quality care, contributing also to resource rationalization and improvement of health systems.

Ability to develop clinical guidelines in several areas:

• Specific pathologies/diseases
• Diagnostic methods
• Rational therapeutic systems
• Preventive Medicine (screening)


Chronic Disease Management

Chronic disease management is a coordinated and systematic approach to improve care for patients with chronic diseases, with the main objectives being the improvement of quality of life and health outcomes, as well as reducing their clinical progression and complication rates.

• Structural networks and integrated information systems for development of chronic disease surveillance programs (prevention, detection and monitoring)
• Development of clinical and organizational strategies to improve health outcomes


Corporate governance

The processes of governance in health institutions require a structured vision and a clear definition of strategic objectives, as well as the procedures and resources to achieve them.

The strategic and operational planning, along with contractual mechanisms, are key elements in the relationship between the various decision makers and the formalization of commitments between the providers of health care and the funders.

The framework of corporate governance needs a proper risk management structure and decision support systems:

• Strategic operation and planning
• Contract implementation
• Internal audit and risk management
• Management of information and business intelligence in health


III. Continuing professional development in health

Continuing professional development is a priority area in modern health systems. Training courses are of particular importance, as they allow updating relevant information for the health decision-making process.

The CEMBE-HEALTH offers different types of courses, with a view to continuing education (CME), depending on the needs of the professionals:

Clinical area and biomedical research

• Diagnosis update and therapy of pathologies
• Epidemiology, biostatistics and research methodology
• Development of standards and clinical guidance protocols (guidelines) of diagnosis and treatment based on best evidence
• Research and good clinical practice
• Economic evaluation of drugs
• Clinical governance

Regulatory area

• Legal framework of medicine and medical devices
• MA procedures (legal and formal)
• Pharmacovigilance (methods, logistics, evaluation)
• Control and quality assurance of drugs

Health management area

• Strategic and operational planning of health institutions
• Internal audit and risk management
• Information management, business intelligence and decision support systems
• Contracts and management by objectives

IV. Health information

For health professionals

Scientific publication in health registers is a dimension so significant that it is very difficult for any single health professional to keep up with in the relevant area of their practice. The difficulties of being updated are always present, whether in the selection of scientific sources, or in daily practical application of this information.

Information system of clinical decision support – in the form of operational algorithms – for health professionals focusing on:

• The most prevalent or relevant pathologies
• Diagnostic methods
• Therapeutic standards
• Disease monitoring


For patients

Recent studies show that health outcomes are strongly associated with health literacy. Knowledgeable patients show a reduction of risk factors, a better drug adherence, and consequently a reduction in mortality and morbidity from the most frequent diseases.

Health information system for patients – easy and enjoyable understanding – on:

• Disease prevention
• Promoting healthy lifestyles
• Diagnostic and therapeutic techniques
• Changing behavior.

V. Clinical research and patient registries

The primary (clinical trials) and secondary (systematic reviews and meta-analyzes) research constitute presently a fundamental activity of health institutions. Clinical research is an integral part of the activity of several types of health professionals.

CEMBE hosts Cochrane Portugal (lead by Prof. A. Vaz Carneiro) and the Movements Disorders Group is based in FMUL (lead by Prof. João Costa).

For example, conducting clinical trials in compliance with the principles of good practice implies the need to develop protocols and data collection notebooks, assess the feasibility of studies, proceed with the submission of the project to the competent authorities, manage the team researchers, audit and monitor, manage and analyze databases and writing the results.

Patient registries are an organized system that uses observational studies in order to gather data to assess specific outcomes for a population defined by a particular disease, condition or exposure, and serves one or more scientific purposes, clinically or politically predetermined. They allow the observation of the course of a disease, understand treatment and variations in results, examining factors influencing prognosis and quality of life, describe standards of care and evaluate the effectiveness of interventions.

Information support to:

• Clinical trials
• Observational studies
• Epidemiological studies
• Management of clinical databases and bio-statistical analysis
• Systematic reviews and meta-analyzes.
• Planning, design and construction of patient registries.

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