Selected Organizations in Health Care and Pharmacy 2024/2025 PDF

Selected organizations in health care and pharmacy, role of EMA, FDA, SÚKL and Ministry of Health Department of Social and Clinical Pharmacy Faculty of Pharmacy in Hradec Králové, Charles University PharmDr. Zuzana Juhásová, Ph.D. Socia...

Selected organizations in health care and pharmacy, role of EMA, FDA, SÚKL and Ministry of Health Department of Social and Clinical Pharmacy Faculty of Pharmacy in Hradec Králové, Charles University PharmDr. Zuzana Juhásová, Ph.D. Social Pharmacy 2024/2025 Chambers Drug regulatory agencies Czech chambers (medical, dental, pharmacists) State Institute for Drug Control PGEU European Medicine Agency (EMA) U.S. FDA Professional societies Czech Medical Association of J. E. Purkyně (ČLS JEP) Pharmacists organizations: Other organizations International Pharmaceutical Federation (FIP) Ministry of Health Czech Pharmaceutical Society of ČLS JEP WHO hospital pharmacy: EAHP EFPIA (inovative industry) clinical pharmacy: ESCP Medicines For Europe (generic industry) pharmaceutical care: PCNE GIRP (distributors) IPSF, EPSA, CzPSA pharmacoeconomics, HTA: ISPOR (student organizations) pharmacovigilance: ISOP pharmacoepidemiology: ISPE patient organizations Chambers Professional societies Mandatory for practicing Voluntary membership professionals Various professions can chambers maintains official become members registers of members Societies can be both national coverage national and international ✓ Guarantee expertise of the members ✓ Research and knowledge ✓ Enforce ethical and legal sharing professional standards ✓ Organize scientific ✓ Advocacy for professional rights and conferences interests ✓ Publish scientific journals Chambers in the Czech Republic The Czech Medical Chamber The Czech Dental Chamber The Czech Chamber of Pharmacists The Chambers are independent, non-political autonomous professional organizations associating all physicians, dentists and pharmacists Act on the Czech Medical Chamber, the Czech Stomatological Chamber, and the Czech Chamber of Pharmacists 220/1991 Coll. Chambers in general Chambers are professional self-governing associations that unite members of a particular profession Apart from the Czech Medical Chamber, the Czech Stomatological Chamber, and the Czech Chamber of Pharmacists, there are also other chambers in the Czech Republic. Examples of chambers outside of healthcare: Chamber of architects Chamber of tax advisors Chamber of attorneys Chamber of executors Chamber of notaries Chambers: roles organization structure ✓ ensure that the members of the chamber perform their profession in accordance National level with professional standards, ethics and in a manner prescribed by laws and General Assembly regulations (annual congress of delegates) Board of Directors of the Chamber ✓ guarantee the expertise of their Honorary Board of the Chamber members and confirm the fulfillment of Auditing Commission of the Chamber requirements for the practice of medicine, stomatology and pharmacy, ✓ review and defend the rights and the District level professional interests of their members, ✓ defend the professional honour of their members, District Assembly ✓ maintain the register of their members The Board of Directors of the District Association  Czech Chamber of Pharmacists (ČLnK) = autonomous non-political professional organisation associating pharmacists ✓ guarantees the expertise of its members and confirms compliance with the conditions for practicing the pharmaceutical profession. ✓ ensures that chamber members practice their profession professionally, in accordance with its ethics, and in a manner prescribed by chamber laws and regulations. The Czech Chamber ✓ defends the rights and professional interests of its of Pharmacists members. is discussed within ✓ protects the professional honor of its members Pharmaceutical Care I. ✓ provides legal assistance to its members ✓ maintains a the register of their members Pharmaceutical Group of European Union Pharmaceutical Group of the European Union (PGEU) = professional association representing European community pharmacists National professional associations of community pharmacists are the members of the PGEU Czech Chamber of Pharmacists is the member of PGEU Professional societies Global Societies not limited only to pharmacists: Pharmacoepidemiology Pharmacovigilance Pharmacoeconomics European the Czech Republic Czech Medical Association of J. E. Purkyně  Professional societies: characteristics Professional societies supports research activities in healthcare and the dissemination of scientific information Professional societies increase the level of expert knowledge of its members The membership in professional societies is usually voluntary Professional societies organize conferences and often publish society journals and guidelines Professional societies and chambers can overlap, with some organizations incorporating elements of both societies and chambers, depending on their specific mission and goals. Chambers are more focused on the practical aspects of a profession. Each European country has its own national pharmacy association, representing pharmacists within that country. The membership is usually mandatory for the practising pharmacists.  International Pharmaceutical Federation Fédération Internationale Pharmaceutique (FIP) FIP represents over 4 million pharmacists, pharmaceutical scientists and pharmaceutical educators Founded in 1912 Headquarters: the Hague, Netherlands Its mission is to support global health by enabling progress in pharmaceutical practice, science, and education FIP collaborates with the World Health Organization FIP vision FIP mission Our vision is a world where everyone advancement of: benefits from access to safe, pharmaceutical practice effective, quality and affordable medicines and health technologies, pharmaceutical sciences as well as from pharmaceutical care pharmaceutical education services provided by pharmacists, in collaboration with other healthcare professionals.  FIP congress FIP webinars World Congress of Pharmacy and Pharmaceutical Sciences FIP publications Může jít o obrázek text, kde se píše Pharmacy-based vaccination 12 PAREICE COMMUNICABLE Recent developments, success stories and implementation challenges FIPDevlomt Goals 2023 A fip ADVANCING PHARMACY WORLDWIDE Webinar banner  European Society of Clinical Pharmacy European Society of Clinical Pharmacy (ESCP) Headquarters: Leiden, Netherlands Journal: International Journal of Clinical Pharmacy 1 November 2022: Webinar Rheumatoid Arthritis: Diagnosis, management evidence-based care - ESCP Membership: voluntary Important members from the Czech Republic: doc. PharmDr. Daniela Fialová, Ph.D. PharmDr. Kateřina Malá, Ph.D. prof. RNDr. Jiří Vlček CSc. Member of the General & Research Chair of the Education Committee Past-president (2004-2006) Committee  European Association of Hospital Pharmacists European Association of Hospital Pharmacists (EAHP) EAHP represents and develops the hospital pharmacy profession EAHP Logos | European Association of Hospital Pharmacists within Europe in order to ensure the continuous improvement of care and outcomes for patients in the hospital setting. This is achieved through science, research, education, practice, as well as sharing best-practice Journal: European Journal of Hospital Pharmacy Important members from the Czech Republic: Past-president: member of Scientific Committee: PharmDr. Petr Horák PharmDr. Barbora Košťálová, Ph.D.  Pharmacoeconomics societies Professional Society for Health Economics and Outcomes Research previously International Society for Pharmacoeconomics and Outcomes Research (ISPOR) HEOR = Health Economics and Outcomes Research Czech Pharmacoeconomic Society Czech Pharmacoeconomic Society (ČFES) is a voluntary, independent association of individuals - physicians, pharmacists, and other healthcare professionals. The aim of the ČFES is the advancement, expansion, and support of pharmacoeconomics, health technology assessment (HTA), and outcome research in the Czech Republic.  Pharmacoepidemiology societies International Society for PharmacoEpidemiology (ISPE) Journal: Pharmacoepidemiology and Drug Safety Pharmacovigilance societies International Society of Pharmacovigilance (ISOP) international scientific organisation, which aims to foster pharmacovigilance both scientifically and educationally, and enhance safe and proper use of medicines Journal: Drug Safety Czech Medical Association of J. E. Purkyně Czech Medical Association of J. E. Purkyně (CzMA) is a voluntary independent association of physicians, pharmacists and other personnel in healthcare and affiliated fields The basic organisational units of CzMA JEP are professional societies formed on professional (expert) basis and fellowships of physicians formed on the territorial principle. The CzMA JEP publishes 33 society journals Czech anatomist and physiologist CzMA JEP: mission development and spread of scientific information of medical sciences and affiliated fields, pursues utilization of this information in public healthcare with a special emphasis on preventive activities. increasing the level of expert knowledge of its members in medical sciences and affiliated fields supports research and development activities in healthcare creates conditions for exchange of information and development of cooperation among its members and organisations in the Czech Republic and abroad CzMA JEP societies provide feedback on legislation and undergraduate education at universities  CzMA JEP: structure Examples of professional societies in CzMA JEP Examples of professional societies in CzMA JEP Czech Society of General Practice Czech Society of Rheumatology Czech Neurological Society Czech Gynecological and Czech Society of Gastroenterology Obstetrical Society Czech Paediatric Society Czech Society of Clinical Pharmacology Czech Society of Endocrinology Czech Society on Thrombosis and Czech Professional Society of Haemostasis Clinical Pharmacy Czech Society of Hepatology Czech Pharmaceutical Society ….  Czech Pharmaceutical Society CzMA JEP The Czech Pharmaceutical Society (CzPS) of the Czech Medical Association of Jan Evangelista Purkyně (CzMA JEP) The main objectives of the Czech Pharmaceutical Society activities are to gather, develop and apply in practice new expertise and knowledge in the area of pharmacy and the affiliated fields, as well as to enforce their application in healthcare practice The Czech Pharmaceutical Society organizes Journal: Czech and Slovak Pharmacy indexed in Scopus database professional and educational events to develop and disseminate the most up-to-date knowledge leading to continuous professional development across all pharmaceutical sciences CzPS: Organizational structure 1 November 2022: Webinar Rheumatoid Arthritis: Diagnosis, management evidence-based care - ESCP Assembly of Members Section of Clinical Pharmacy - highest body Section of Pharmacy Practice Committee of the CzPS Section of Hospital Pharmacists EAHP Logos | European Association of Hospital Pharmacists Audit Committee Section of Synthetic Drugs Section of Natural Drugs Sections Section of Pharmaceutical Technology and others… Regional Groups Important member of our department: Chairman of the Head of the section of Committee of the CzPS Scientific Secretary Clinical Pharmacy Drug Regulatory Agencies Czech Republic EU USA United Kingdom  State Institute for Drug Control an organizational unit of the state, with its supervisory authority: Ministry of Health of the Czech Republic The mission of the Institute, in the interest of protecting citizens' health, is to: ✓ Ensure that only pharmaceutically high-quality, effective, and safe human medicines are available in the Czech Republic. ✓ Contribute to ensuring that only safe and functional medical devices are used in the Czech Republic, always accompanied by credible and appropriate information. ✓ Contribute to the rational use of medicines and medical devices, including responsible and ethically clinical trials when necessary. ✓ Ensure the appropriate application of regulatory measures to avoid unnecessary obstacles in the availability of medicines and medical devices and when introducing new treatment SÚKL: activities monitoring the characteristics of human medicines across all areas of their handling. This involves monitoring the quality, effectiveness, and safety of medicines throughout all stages of their development and use. SÚKL conducts national marketing authorization procedures, inspection, laboratory controls, monitors the use of medicines in practice, oversees medicine advertising, and gathers relevant information (pharmacovigilance, drug utilization) SÚKL conducts price & reimbursement regulation over medicinal products, and medical devices. SÚKL makes decisions in administrative proceedings regarding the maximum prices of medicinal products , as well as the extent and conditions of their reimbursement by health insurance. SÚKL operates an electronic prescription information system (ePrescription) SÚKL manages records of registered medicinal products, conducted inspections, and ethical committees. SÚKL: activities SÚKL grants permits for the production of medicinal products, licenses for the activity of control laboratories, and permits for the distribution of medicinal products. SÚKL issues certificates that attest to the fulfillment of conditions for good manufacturing practice, good distribution practice, good clinical practice, good pharmacy practice. It acts as the authority responsible for fulfilling the Czech Republic's tasks in the field of pharmacovigilance. SÚKL monitors falsified medicinal products. SÚKL maintains a list of websites with illegal offers of medicinal products. Based on evaluations of drug shortages, it communicates information to the Ministry of Health and submits proposals for issuing general measures. SÚKL: organization structure section of section of Marketing section of Pricing section of Surveillance Authorization & Reimbursemet Medical Devices GLP inspection Clinical trials Administrative Notification of GCP inspection Procedure Medical Devices Clinical trial authorization GMP inspection and evidence, list of ethical Coordination Medical Devices inspection of committees pharmacies Health Technology Evaluation and inspection of Marketing Authorization Assessment: Vigilance distributors Documentation clinical evaluation, Medical Devices control of pricing Assessment pharmacoeconomic Reimbursement control of Pharmacovigilance assessment advertising + Division of Drug Availability and Substitutability (dealing with drug shortages) Surveillance section The Pharmacy and Distribution Department of the Surveillance section ensures compliance with legislative requirements in the distribution of medicines, focusing on the principles of good distribution practice. SÚKL issuse permits for distribution activities, maintain a registry of medicinal product intermediaries, and oversee the dispensing, sale, and preparation of medicinal products. Entities under scrutiny include distributors, pharmacies, sellers of restricted medicinal products, and specialized healthcare facility units. The Inspection Department of the Surveillance section supervises activities related to drug production, proper clinical and laboratory practices, and issues binding opinions on the import and export of medicinal products. The Advertising Regulation Division oversees compliance with advertising regulations concerning human medicinal products and sponsorship (excluding radio and television broadcasting) Marketing authorization section During the marketing authorization process, documentation is assessed wherein the future holder of the marketing authorization demonstrates the safety, efficacy, and quality of the product. This includes the evaluation of indications, contraindications, dosage, classification for dispensing, Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and proposed texts for the medicinal product packaging. The Clinical Trials Department conducts assessments of applications for authorization of clinical trials and oversees the progress of these clinical trials. The Department of Pharmacovigilance is in charge of ensuring the safety of medicinal products. The pharmacovigilance activities comprise of the collection of data about potential risks of pharmaceuticals (e.g. from the system of spontaneous reporting if suspected adverse drug reaction) implementation of regulatory measures intended for risk minimisation, and of communicating new safety information both to professionals and to the general public. Pricing & Reimbursement Regulation Pricing and Reimbursement regulation section determines the maximum prices and reimbursements for medicinal products and food for special medical purposes. The determination pf the maximum prices and reimbursements occurs within an administrative procedure that complies with transparent procedures according to European legislation. Basic instrument - reference pricing (= deriving price from somewhere else) other countries = external reference maximum ex- therapeutically similar drug + VAT + mark-up factory price = internal reference Reimbursement regulation Regulation of reimbursement price Retail price co-payment The difference between the retail price and the reimbursement price is the co-payment in reimbursement from pharmacy health insurance Regulation of reimbursement conditions: Prescription restriction drug may be prescribed only by a physician with a particular specialization Indication restriction drug may be prescribed only to a pre-defined (sub)population of patients or diagnoses or health states European Medicines Agency (EMA) established in 1995 location: Amsterdam, the Netherlands  EMA: Research & development EMA, in cooperation with the EU Member States, plays a key role in ensuring that medicine developers follow EU and international standards. These rules, called good clinical practice, apply to the way they design the studies, how they record their results and how they report these results. These rules are in place to ensure that studies are scientifically sound and conducted in an ethical manner EMA cannot compel companies to research particular medicines for a particular condition. However, EMA does publicise areas where there is a need for new medicines – for example, new antibiotics In addition, the EU legislation provides measures to encourage companies to develop medicines for rare diseases (fee reductions when obtaining scientific advice from EMA.) EU legislation rewards and incentives to encourage manufacturers to research and develop medicines for children  EMA: Scientific advice EMA provides scientific advice to support the timely and sound development of high- quality, effective and safe medicines, for the benefit of patients. EMA provides scientific advice because: Better designed studies are more likely to generate robust and complete data to show whether or not a medicine works and is safe. The sooner it can be shown that a new medicine works and is safe, the sooner it can be made available to patients. Providing advice means that patients are not deprived of beneficial medicines simply because poorly designed trials failed to demonstrate that the medicine works and is safe. Better study designs avoid patients taking part in studies that will not produce useful evidence. Examples of questions addressed during scientific advice: Are the patients to be included in a study sufficiently representative of the population for whom the medicine is intended? Does the study last long enough and include enough patients to provide the necessary data for the benefit-risk assessment?  EMA: Evaluation The balance between the benefits and risks of a medicine is the key principle guiding a medicine’s assessment. A medicine can only be authorised if its benefits outweigh the risks. When assessing the evidence gathered on a medicine, EMA determines whether the benefits of the medicine outweigh its risks in the group of patients for whom the medicine is intended. EMA’s Committee for Medicinal Products for Human Use (CHMP) assesses applications submitted by medicine developers and recommends whether or not a medicine should be granted marketing authorisation. Once a decision has been taken on the approval or refusal of a marketing authorisation, EMA publishes a comprehensive set of documents called the European public assessment report (EPAR). This includes the public CHMP assessment report, which describes in detail the data assessed and why the CHMP recommended approving or refusing authorisation.  EMA: Marketing authorisation EMA is a scientific body with the expertise required to assess the benefits and risks of medicines. However, under EU law it has no authority to actually permit marketing in the different EU countries. The role of EMA is to make a recommendation to the European Commission which then takes a final legally binding decision on whether the medicine can be marketed in the EU. The Commission is thus the authorising body for all centrally-authorised products.  EMA: Patient access to medicines Once a medicine has received an EU-wide marketing authorisation, decisions about pricing and reimbursement take place at national and regional level As those choices must be made in the context of the national health system of each country, EMA has no role in decisions on pricing and reimbursement. Medicines that are granted a marketing authorisation by the European Commission can be marketed throughout the EU. However, it is up to the company holding the authorisation to decide in which EU countries the medicine will be marketed. EMA collaborates with national bodies, such as health technology assessment (HTA) bodies, to facilitate decisions about pricing and reimbursement Health technology assessment (HTA) bodies assess the relative effectiveness and safety of the new medicine in comparison with existing medicines  EMA: Health technology assessment Health technology assessment (HTA) is a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing health technologies. HTA focuses specifically on the added value of a health technology in comparison with other new or existing health technologies. HTA can cover both clinical and non-clinical aspects of a health technology, depending on the healthcare system. Clinical domains of assessment concern the identification of a health problem and current health technology, the examination of the technical characteristics of the health technology under assessment, its relative safety, and its relative clinical effectiveness. Non-clinical assessment domains concern cost and economic evaluation of a health technology, and its ethical, organisational, social and legal aspects. EU Regulation on HTA joint clinical assessment from 2030 (comparative safety and effectiveness)  EMA: Safety monitoring Once a medicine has been authorised for use in the EU, EMA and the EU Member States constantly monitor its safety and take action if new information indicates that the medicine is no longer as safe and effective as previously thought The safety monitoring of medicines involves a number of routine activities ranging from: assessing the way risks associated with a medicine will be managed and monitored once it is authorised; continuously monitoring suspected adverse drug reactions reported by patients and healthcare professionals identified in new clinical studies or reported in scientific publications; regularly assessing reports submitted by the company holding the marketing authorisation on the benefit-risk balance of a medicine in real life; and assessing the design and results of post-authorisation safety studies which were required at the time of authorisation. pharmacovigilance  EMA – committees Committee for Committee for Committee on Herbal Medicinal Products for Medicinal Products Medicinal Products Human Use (CHMP) for Veterinary Use recommends marketing recommends marketing authorization of human authorization of veterinary Paediatric Committee medicinal products, referral medicinal products, referral procedure, scientific advice procedure, scientific advice Pharmacovigilance Risk Assessment Committee for Orphan Committee for Committee (PRAC) Medicinal Products Advanced Therapies Signal Detection, Assessment, Risk Minimization, Communication Assessment of Orphan gene therapy design of Post-Registration Safety Designation Applications somatic cell therapies Studies rare disease: ˂5 in 10,000 tissue engineering Pharmacovigilance Audits  U.S. FDA U.S. Food & Drug Administration federal agency of the Department of Health and Human Services The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.  U.S. FDA and drug regulation Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States As part of the U.S. Food and Drug Administration, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. Drug Information, Safety, and Availability: Medication Guides, Drug Safety Communications, Shortages, Recalls Drug Approvals and Databases: Drugs@FDA, Orange Book, National Drug Code, Recent drug approvals Drug Development and Review Process: Drug applications, submissions, manufacturing, and small business help Guidance, Compliance, and Regulatory Information: Guidances, warning letters, drug compounding, international information, registration and listing Regulatory Science and Research: CDER research programs, initiatives, and resources Other organizations Innovative industry Generic industry Distributors  Ministry of Health The central authority of state administration oversees: Healthcare and public health protection Medical scientific research activities Handling addictive substances, preparations, precursors, and auxiliary substances Seeking, safeguarding, and utilizing natural medicinal resources, natural health resorts, and sources of natural mineral waters Pharmaceuticals and medical devices for the prevention, diagnosis, and treatment of individuals Health insurance Healthcare information system The Ministry of Health of the Czech Republic directly manages certain healthcare facilities and other organizations: Institute of postgradual education in healthcare (IPVZ), The Institute of Health Information and Statistics of the Czech Republic (UZIS), State Institute for Drug Control (SÚKL), National Institute of Public Health (SZÚ) Role of the Ministry of Health Ministry formulates strategies for the development of the Czech healthcare system: The ministry of health prepares legislation Price regulation of medicinal products The ministry of health forms health policy (mark-up percentage regulation) The ministry's agendas encompass: The Ministry of Health regulates Crisis management maximimum mark-up percentage Quality and safety of healthcare services (shared by distributor and pharmacy) Patients' rights and obligations Medical devices maximum ex- + mark- + VAT Czech Inspectorate of Spas and Springs factory price up Pharmaceuticals Addictive substances and drug precursors Tax Health insurance Healthcare services maximum pharmacy retail price Role of the Ministry of Health The Ministry of Health decides on the approval of specific therapeutic programs The Ministry of Health issues the Czech Pharmacopoeia The Ministry of Health creates conditions to ensure the availability of medicinal products significant for providing healthcare services and takes measures to support research, development, and availability of medicinal products for rare diseases The Ministry of Health might restrict or prohibit the distribution of medicinal products abroad The Ministry of Health determines medicinal products whose shortages would endanger the patient treatment The Ministry of Health may, with government consent, ensure the availability of medicinal products significant for public health protection by purchasing or distributing them if their availability cannot be ensured otherwise The Ministry of Health issues measures allowing the distribution, dispensing, and use of unregistered medicinal products  World Health Organization WHO is the United Nations agency 194 member states across 6 regions Headquarters: Geneva (Switzerland) WHO Regional WHO connects nations, partners and people to promote Office for Europe health, keep the world safe and serve the vulnerable – so everyone, everywhere can attain the highest level of health. The highest governing body is the World Health Assembly (WHA), which convenes annually in May in Geneva, with the presence of health ministers from all member states World health day (7. april) - Constitution of the WHO entered into force on 7 April 1948 WHO activities WHO's activities include formulating health policies and providing consulting services based on the needs of member states, offering expert assistance in developing national healthcare strategies, monitoring indicators of population health status and assessing healthcare systems of individual countries, and developing and testing new technologies and procedures for disease control and healthcare management. ✓ health promotion WHO is has several WHO collaborating centres ✓ strengthening Uppsala Monitoring Centre (UMC) healthcare systems = WHO Collaborating Centre for International Drug Monitoring ✓ applying research and existing knowledge in WHO Collaborating Centre for Drug Statistics Methodology formulating priorities → ATC-DDD methodology (used in drug utilization research) and strategies WHO Collaborating Centre for the Family of International Classifications ✓ enhancing collaboration → ICD classification (International Classification of Diseases) WHO constitution Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition. The health of all peoples is fundamental to the attainment of peace and security and is dependent on the fullest co-operation of individuals and States. The achievement of any State in the promotion and protection of health is of value to all. Unequal development in different countries in the promotion of health and control of diseases, especially communicable disease, is a common danger. Healthy development of the child is of basic importance; the ability to live harmoniously in a changing total environment is essential to such development. Governments have a responsibility for the health of their peoples which can be fulfilled only by the provision of adequate health and social measures.  Associations of innovative industry European innovative industry European Federation of Pharmaceutical Industries and Associations (EFPIA) Czech innovative industry Association of Innovative Pharmaceutical Industry (AIFP) AIFP brings together 34 companies developing and bringing new, more effective, safer medicines to patients. AIFP is a member of the European Federation of Pharmaceutical Companies and Associations (EFPIA) and works extensively with the International Federation of Pharmaceutical Industries and Associations (IFPMA) and the Innovative Pharmaceutical Companies of America (PhRMA).  Associations of generic industry European generic industry Medicines for Europe Czech generic industry Czech Association of Pharmaceutical Companies ČAFF unites the main producers of generic and biosimilar drugs in the Czech Republic ČAFF is a member of Medicines for Europe  Associations of distributors European distributors wholesale distributor European Healthcare Distribution Association (GIRP) - large scale and scope of their operations Czech distributors Association of Wholesale Distributors of Pharmaceuticals (AVEL) members: Alliance Healthcare, ViaPharma, PHOENIX AVEL is member of GIRP  Student organizations Czech Pharmaceutical Students' Association Hradec Králové Pharmacy Students' Union Brno European Pharmaceutical Students' Associations (EPSA) International Pharmaceutical Students Federation (IPSF)  Patient organizations Patient organizations represent the interests of patients within the healthcare system and highlight the issues that life with a particular diagnosis brings. There are approximately a hundred such organizations in the Czech Republic, with each focusing on a specific health area. The role of patients in regulatory affairs: Representatives of patients are members of several EMA committees Decision-making on the reimbursement of orphan drugs in the Czech Republic → involvement of representatives from patient organizations  Chambers Czech Medical Chamber, Czech Dental Chamber, Czech Chamber of Pharmacists Chambers are independent, non-political autonomous professional organizations associating all physicians, dentists and pharmacists roles of chambers: ✓ ensure that the members of the chamber perform their profession in accordance with professional standards, ethics and in a manner prescribed by laws and regulations ✓ guarantee the expertise of their members and confirm the fulfillment of requirements for the practice of medicine, stomatology and pharmacy, ✓ defend the rights and the professional interests of Czech Chamber of Pharmacists their members, is the member of Pharmaceutical ✓ defend the professional honour of their members, Group of the European Union (PGEU) ✓ maintain the register of their members = professional association representing European community pharmacists national vs district level  Professional societies The Czech Pharmaceutical Society of the Czech Medical Society of Jan Evangelista Purkyně objective: to gather, develop, and apply new knowledge in the field of pharmacy sections cover various domains including clinical pharmacy, pharmacy practice, hospital pharmacy, pharmaceutical technology, natural and synthetic medicines, and others Society journal: Czech and Slovak Pharmacy International Pharmaceutical Federation (FIP) advances pharmaceutical practice, science, and education European Society of Clinical Pharmacy Society journal: International Journal of Clinical Pharmacy European Association of Hospital Pharmacists Society journal: European Journal of Hospital Pharmacy ISOP (pharmacovigilance), ISPE (pharmacoepidemiology), ISPOR (pharmacoeconomics)  Regulatory autorities Drug regulatory authorities, such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or the State Institute for Drug Control (SÚKL) in the Czech Republic play crucial roles in ensuring the safety, efficacy, and quality of pharmaceuticals: ✓ Oversight of clinical trials (approving trial initiation, and monitoring compliance with ethical and scientific standards to protect patient safety) ✓ Granting marketing autorization (approval) of medicinal products (thorough review of preclinical and clinical trial data submitted by pharmaceutical companies to ensure that the benefits of a drug outweigh the risks) ✓ Management of the database of authorized medicinal products ✓ Pharmacovigilance (post-marketing surveillance of drug safety) ✓ Inspection of GLP, CCP, GMP, GDP and pharmacies, control of advertisement ✓ Communication (e.g. drug approvals, safety updates, shortages and recalls)  Ministry of Health Roles Ensures quality and safety of healthcare services Regulation of mark-up decides on the approval of specific therapeutic programs might restrict or prohibit the distribution of medicinal products abroad determines medicinal products whose shortages would endanger the patient treatment Organizations directly under the Ministry of health: National Institute of Public Health (SZÚ) State Institute for Drug Control (SÚKL) Institute of Postgraduate Education in Healthcare (IPVZ) Institute of Health Information and Statistics of the Czech Republic (ÚZIS ČR) World Health Organization (WHO) United Nations agency established in 1948 (7 April 1948) WHO connects nations, partners and people to promote health, keep the world safe and serve the vulnerable – so everyone, everywhere can attain the highest level of health. WHO's activities include formulating health policies and providing consulting services based on the needs of member states, offering expert assistance in developing national healthcare strategies, monitoring indicators of population health status and assessing healthcare systems of individual countries, and developing and testing new technologies and procedures for disease control and healthcare management. WHO Collaborating Centres : Uppsala, Sweden: Uppsala Monitoring Centre = UMC (pharmacovigilance), Oslo, Norway: Drug Statistics Methodology (drug utilization- ATC/DDD), WHO Collaborating Centre for the Family of International Classifications (ICD classification)  Manufacturers and distributors European Federation of Pharmaceutical Industries and Associations (EFPIA) - innovative pharmaceutical industry Medicines For Europe - generic, biosimilar and valued added pharmaceutical industries European Healthcare Distribution Association (GIRP) - healthcare distributors in Europe - represents over 750 pharmaceutical wholesale distributors