EMA Regulatory Science To 2025 - European Medicines Agency
EUROPEAN MEDICINES AGENCYS C IE N C EM EDIC I N E SH e a lt hEMA Regulatory Science to 2025Strategic reflection
ContentsForeword by Prof. Guido Rasi, EMA Executive Director1Vision — Human medicines2Vision — Veterinary medicines41. Introduction — the regulatory framework62. A strategic reflection73. Human medicines — five strategic goals for regulatory science103.1 Goal 1: Catalysing the integration of science and technologyin medicines development103.2 Goal 2: Driving collaborative evidence generation improving the scientificquality of evaluations193.3 Goal 3: Advancing patient-centred access to medicines in partnershipwith healthcare systems303.4 Goal 4: Addressing emerging health threats and availability/therapeutic challenges403.5 Goal 5: Enabling and leveraging research and innovation in regulatory science464. Veterinary medicines — four strategic goals for regulatory science524.1 Goal 1: Catalysing the integration of science and technologyin medicines development524.2 Goal 2: Driving collaborative evidence generation and improving the scientific quality ofevaluations574.3 Goal 3: Addressing emerging health threats and availability/therapeutic challenges654.4 Goal 4: Enabling and leveraging research and innovation in regulatory science705. Working together: international regulatory science cooperation756. List of acronyms76
Foreword by Prof. Guido Rasi, EMA Executive DirectorEMA’s motto is “Science, Medicines, Health”, meaningThis is why I asked the Chairs of the Scientificthat science is at the foundation of everything that weCommittees to reflect upon these questions anddo in trying to make medicines accessible to patientspropose our future regulatory science strategy, whichand animals for the benefit of public health.was built by consulting our key stakeholders via apublic consultation and workshops.The pace of innovation has accelerated dramaticallyin recent years and regulators need to be ready toWhile we must absorb the disruption resulting fromsupport the development of increasingly complexBrexit, the European network needs to prepare formedicines that more and more deliver healthcarethe broader challenges that will face us as a systemsolutions by converging different technologies toover the next 5 to 10 years. There are many areaspromote and protect human and animal health.where there is a need for more collaboration acrossthe European regulatory landscape to improve theFrom a global perspective as I have been travellinginnovation environment and enhance patient accessaround there is great interest expressed in horizonto new medicines (“more Europe in healthcare”).scanning activities to identify key innovations inWith regards to the veterinary landscape wescience and technology that are likely to impacthave the immediate challenge of implementingregulatory systems.the Veterinary Medicines Regulation (EU) 2019/6over the coming years. However, we also mustIt is our duty to constantly challenge our capacitylook beyond the Veterinary Medicines Regulation (EU)to regulate:2019/6 and attempt to engage with the challengesand opportunities presented by new technologies How ready are we to engage with emergingscience and technological innovations such as bigand their translation into veterinary medicinesdevelopment.data, precision medicine, novel manufacturing,novel clinical trials design, and the revolution inThe outcome of this exercise is a key element withinsynthetic biology?the next European Regulatory Network Strategyto 2025, which will be developed together with the Do we have the necessary skills andMember States, the European Commission and ourcompetencies, or indeed access to the specificstakeholders. It will enable us to keep on top ofexpertise required?developments, identify the gaps between science andhealthcare systems and bring together the various Are we generating new guidance or providingstakeholders needed to bridge those gaps.sufficient levels of advice to facilitate theutilisation and translation of these innovations? 1
Vision — Human medicines“To underpin its mission of protecting human health, EMA must catalyse and enableregulatory science and innovation to be translated into patient access to medicinesin evolving healthcare systems.”Strategic goals and core recommendations - Human medicines11. Catalysingthe integration Support developments in precision medicine, biomarkersand ‘omicsof science andtechnologyin medicines’ Support translation of advanced therapy medicinal products(ATMPs) into patient treatmentsdevelopment Promote and invest in the PRIME scheme Facilitate the implementation of novel manufacturing technologies Create an integrated evaluation pathway for the assessmentof medical devices, in vitro diagnostics and borderline products Develop understanding of, and regulatory response to, nanotechnology andnew materials in pharmaceuticals Diversify and integrate the provision of regulatory advice along thedevelopment continuum2. Driving Leverage non-clinical models and 3Rs principles collaborativeevidence generation Foster innovation in clinical trials– improving thescientific qualityof evaluations Develop the regulatory framework for emerging clinical datageneration Expand benefit-risk assessment and communication Invest in special populations initiatives Optimise capabilities in modelling, simulation and extrapolation Exploit digital technology and artificial intelligence in decision making1 The core recommendations in bold were those prioritised by the stakeholders and subsequently discussed in the 2019workshop. Core recommendations whose underlying actions have cross relevance to human and veterinary fields.2
3. Advancingpatient-centred Contribute to HTA’s preparedness and downstream decision makingfor innovative medicinesaccess to medicinesin partnership with Bridge from evaluation to access through collaboration with payershealthcare systems Reinforce patient relevance in evidence generation Promote use of high-quality real-world data (RWD)in decision-making Develop network competence and specialist collaborations to engagewith big data Deliver improved product information in electronic format (ePI) Promote the availability and support uptake of biosimilarsin healthcare systems Further develop external engagement and communications to promotetrust and confidence in the EU regulatory system4. Addressingemerging health Implement EMA’s health threats plan, ring-fence resources and refinepreparedness approachesthreats andavailability/therapeutic Continue to support development of new antibacterial agents andtheir alternatives challenges Promote global cooperation to anticipate and address supply problems Support innovative approaches to the development, approval andpost-authorisation monitoring of vaccines Support the development and implementation of a repurposing framework5. Enabling andleveraging research Develop network-led partnerships with academic/research centresto undertake research in strategic areas of regulatory scienceand innovation inregulatory science Leverage collaborations between academia and network scientists toaddress rapidly emerging regulatory science research questions Identify and enable access to the best expertise across Europe andinternationally Disseminate and exchange knowledge, expertise and innovation acrossthe network and to its stakeholders 3
Vision — Veterinary medicines“To foster scientific excellence in the regulation of veterinary medicines for the benefitof animal and public health while facilitating and promoting innovation and access tonovel medicinal products.”Strategic goals and core recommendations - Veterinary medicines21. Catalysing Transform the regulatory framework for innovative veterinary medicinesthe integrationof science and Reinforce and further embed application of the 3Rs principles technologyin medicines Facilitate implementation of novel manufacturing modelsdevelopment2. Driving Update Environmental Risk Assessments in line with the latest scientific knowledge collaborativeevidencegeneration - Apply the latest scientific principles to the assessment of the safety of residuesof veterinary medicinesimproving thescientific qualityof evaluations Collaborate with stakeholders to modernise veterinarypharmacoepidemiology and pharmacovigilance Develop new and improved communication and engagement channels andmethods to reach out to stakeholders Develop new approaches to improve the benefit-risk assessment ofveterinary medicinal products3. Addressingemerging health Continue to promote the responsible use of antimicrobials and theiralternatives threats andavailability/therapeutic Coordinate network activities to improve data collection on antimicrobial use inanimalschallenges Engage with stakeholders to minimise the risks of antiparasitic resistance Promote and support development of veterinary vaccines4. Enablingand leveraging Develop network-led partnerships with academic/research centres to undertakeresearch in strategic areas of regulatory scienceresearch andinnovationin regulatory Leverage collaborations between academia and network scientists to addressrapidly emerging regulatory science research questionsscience Identify and enable access to the best expertise across Europe and internationally Disseminate and exchange knowledge, expertise and innovation across thenetwork and to its stakeholders2 The core recommendations in bold were those prioritised by the stakeholders and subsequently discussed in the 2019 workshop. Core recommendations whose underlying actions have cross relevance to human and veterinary fields.4
1. Introduction — the regulatory frameworkThe European regulatory system for medicines (thesafety and efficacy assessment of medicinal‘EU network’, or EMRN) is a network of all theproducts and that inform regulatory decision-national medicines regulators (human andmaking throughout the lifecycle of a medicine. Itveterinary) from EEA member states, the Europeanencompasses basic and applied biomedical and socialMedicines Agency (EMA) and the Europeansciences and contributes to the development ofCommission. This unique system serves a populationregulatory standards and tools.”3of over 400 million people.As science and technology advance and bringThe ultimate role of this network is to promotepotential new treatments and diagnostic tools,and protect the health of those it serves throughregulatory science must advance in tandem so thatmedicines regulation. This means ensuring that boththese can be correctly, rigorously and efficientlypeople and animals in Europe have timely accessassessed. Examples of the transformationalto medicines that are safe, effective and of suitableresearch that is having a significant impact onquality, as well as the information needed to usethe regulatory science agenda include cell-basedthose medicines and make informed choices abouttherapies, genomics-based diagnostics, drug-devicetheir treatment.combinations, novel clinical trial design, predictiveIn addition, the EU network is responsible forartificial intelligence.toxicology, real-world evidence, and ‘big data’ andproviding a regulatory environment that supportsinnovation and the development of new and betterA public health aimmedicines to meet human and animal health needs.To do this, they must proactively engage with andThe reflection on potential areas of regulatory sciencefoster advances in regulatory science and workengagement described in this document recognisesclosely with all their stakeholders.that science, technology and information (quantity,What is regulatory science?handling, dissemination) are rapidly changing societyin general, and medicinal product development inparticular, and that regulators must keep up.“Regulatory science is defined as the range ofscientific disciplines that are applied to the quality,3 Source: EMA’s road map to 2015. 5
It follows that the EU network must have accessincluding health technology assessors and payers,to the best and most up-to-date scientific data,and the pharmaceutical industry. This diverse groupmethodologies and tools available on which to baseof stakeholders all have a role to play in the ongoingdecisions. We recognise too that regulators aredevelopment of the network.only one element in the decision-making chain, andthat continued and expanded collaboration with ourstakeholders and partners at every level is key toensuring that patients and animals and caregivershave the medicines they need, and the informationrequired to make decisions about their use. Theproposed goals, recommendations and actions aimto ensure that regulators can advance protectionof public health and provide European citizenswith optimal medicines regulation in the comingyears. They will also aid the delivery of several UNSustainable Development Goals (SDG), mainly withinSDG Goal 3 (3.4, 3.D).Who are our stakeholders?Ultimately, what we do is intended for the benefitof patients and animals. They, and the healthcareprofessionals who treat them, are at the core of ourmission. In order to serve them well, and throughthem wider civil society, we must also engage withthe needs of academic and research communities,other regulatory and government institutions6
2. A strategic reflectionThis strategic reflection sets out working proposalsthe impact would be greatest. This need was madeon the key areas with which EMA intends to engage,even more acute as a result of the UK leaving the EU.in order to ensure that it has the regulatory toolsto continue supporting the network and fulfilling itsTo begin the reflection process, SciCoBoongoing mission despite new scientific challenges.commissioned a detailed baseline report in 2017The document identifies 5 strategic goals for suchlooking at the key trends in science, technology andengagement on the human medicines side, and 4regulation that will impact the operations of EMA andaligned strategic goals for veterinary medicines; itthe network. This report built on EMA’s extensiveproposes core recommendations and underlyingand ongoing work in many of these areas, and aactions that would need to be taken to support these.developing horizon-scanning capacity.The goals and proposed recommendations inTo build in stakeholder input from the early stages,the strategic reflection have been prepared inan extensive series of outreach activities werecollaboration with our many stakeholders.conducted with stakeholders at all levels of theHow were the goals andrecommendations derived?medicine development pathway: Healthcare professionals and patientrepresentative groupsIn its central role within the EU network, EMA andits 7 scientific committees must routinely engage European research infrastructure networks,with advances in regulatory science, a processscientific organisations and associations, andplanned and monitored through its multiannualacademic scientistswork programme and coordinated by its ScientificCoordination Board (SciCoBo). Experts in regulatory science (chairs of allEMA working parties and Scientific AdvisoryDuring an environmental impact assessmentGroup chairs)conducted in 2016 the need for a strategic reflectionwas identified. The aim was to allow best allocation ofnecessarily limited network resources to areas where Representatives from health technologyassessors and payers 7
Representatives of industry, small and mediumwas presented at the end of 2018 for a 6-monthssize enterprises and industry associationspublic consultation to allow the wider stakeholdercommunity to have its say. Responses received wereAll the inputs from these exercises were distilledboth qualitative and quantitative.into this strategic reflection document, whichFigure 1. Stakeholder types: how responses were groupedCluster 1(IPCO )Cluster 2(HCP) Individualmember of thepublic Healthcareprofessionalorganisation Patient orConsumerOrganisation Healthcareprofessional Advocacy groupCluster 3(Research) Other scientificorganisation European researchinfrastructure AcademicresearcherCluster 4(Public body) EU regulatorypartner / EUinstitution Healthtechnologyassessment bodyCluster 5(Industry) Pharmaceuticalindustry (tradeassociation,individualcompany, SME) Payer Learned societyFigure 2. Responses to the public consultation by stakeholder type504543454140303530252020HCPPublic body20151050ResearchIndustryIPCOStakeholders were asked to identify the coreThe cumulative results by stakeholder group arerecommendations that they believed would deliverpresented in figures 3 and 4 for the human area andthe most significant change in the regulatory system5 and 6 for the veterinary area.over the next five years.8
Figure 3. Top 5 core recommendations thought to deliver the most significant change - Human409. Foster innovation in clinical trials3518. Promote use of high-quality real-world data(RWD) in decision making302517. Reinforce patient relevance in evidencegeneration201515. Contribute to HTA’s preparedness anddownstream decision making for innovativemedicines1050R9.Cluster 1R18.Cluster 2R17.Cluster 3R15.Cluster 4R1.1. Support developments in precision medicine,biomarkers and ‘omicsCluster 5Figure 4. Next 5 core recommendations thought to deliver the most significant change - Human2511. Expand benefit-risk assessment andcommunication202. Support translation of advanced therapymedicinal products (ATMPs) into patient treatments155. Create an integrated evaluation pathway for theassessment of medical devices, in vitro diagnosticsand borderline products10507. Diversify and integrate the provision ofregulatory advice along the development continuumR11.Cluster 1R2.Cluster 2R5.Cluster 3R7.Cluster 4R29.Cluster 529. Leverage collaborations between academia andnetwork scientists to address rapidly emergingregulatory science research questionsFigure 5. Top 3 core recommendations thought to deliver the most significant change - Veterinary16R32. Transform the regulatory framework forinnovative veterinary medicines1412R39. Develop new approaches to improve thebenefit-risk assessment of veterinary medicinalproducts108R37. Collaborate with stakeholders to moderniseveterinary pharmacoepidemiology andpharmacovigilance6420Cluster 1R32.Cluster 2R39.Cluster 3R37.Cluster 4Cluster 5 9
Figure 6. Next 3 core recommendations thought to deliver the most significant change - Veterinary5R33. Reinforce and further embed applicationsof the 3Rs principles4R40. Continue to promote the responsible useof antimicrobials and their alternatives3R43. Promote and support developmentof veterinary vaccines210R33.Cluster 1R40.Cluster 2Cluster 3R43.Cluster 4Cluster 5In 2019, we used the ranking results above toThis implementation planning will establishhold finalisation workshops to develop the coreprioritisation and measurable outcomes for eachrecommendations that were expected to deliver thecore recommendation and its underlying actions.most significant change over the next five years.These will be translated into detailed initiatives andembedded into work plans for EMA and its scientificThe qualitative responses were summarised usingcommittees/working parties. In addition, actionsframework analysis and the detailed results can beinvolving the network will inform the development offound here.the network strategy for the next 5 years, and will be4delivered via the HMA multiannual workplan, and theAll comments received on the draft EMA ‘RegulatoryNational Competent Authorities’ workplans.science to 2025’ strategy can be found here.As a result of the analysis of the responses receivedduring the public consultation and the feedbackreceived during the workshops, we have updated thestrategy to include revised core recommendationsand underlying actions. The extensive responsesreceived identified a multiplicity of actions, manyof which are too detailed to be included within thisstrategic reflection. These will nevertheless be takeninto account in the detailed implementation planning.4 1. Gale N, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data inmulti-disciplinary health research. BMC medical research methodology. 2013;13(1):117.2. Lacey A, Luff D. Qualitative Research Analysis: The NIHR RDS for the East Midlands / Yorkshire & the Humber; 2007.10
3. Human medicines — five strategic goalsfor regulatory scienceFigure 7. Human strategic goalsFIVEGOALSCatalysing the integrationof science and technologyin medicines’ developmentEnabling and leveragingresearch and innovationin regulatory sciencefor humanmedicinesregulationAddressing emerging healththreats and availability/therapeutic challengesDriving collaborative evidencegeneration – improving thescientific quality of evaluationsAdvancing patient-centred accessto medicines in partnership withhealthcare systemsEMA seeks to help regulatory science developinnovation to be translated into patient access inand use it to ensure that advances in knowledgeevolving healthcare systems.translate in a timely way into new, safe and effectivetreatments for patients.To this end, 5 strategic goals are proposed. Each isassociated with a set of core recommendations andThe vision for human medicines is that to underpintheir supporting actions.its mission of protecting human health, EMAmust catalyse and enable regulatory science and 11
3.1 Goal 1: Catalysing the integration of science and technologyin medicines developmentSummary tableThe ultimate public health aim is to ensure that regulation can support the development of newmedicines and innovative techniques, so that patients’ needs can be better addressed with safer, moreeffective and clinically appropriate treatments. This requires the network to address, for example,moves to more patient-centred healthcare, and precision, or personalised, medicine.We wish to see the latest scientific and technological knowledge built into medicines developmentwhere it benefits public health. This requires closer collaboration with academics, research centres andinfrastructures and ensuring that this is embedded into the ongoing dialogue between regulators anddevelopers at all stages of the process. Such dialogue is vital to ensure that evidence generation plansare designed to address relevant questions for later decision making, so that patients are only enrolledin relevant and high-quality study programmes. Building on and developing existing mechanisms forthis, in particular the scientific advice processes that already form a successful part of the EU network’sregulatory pathways, EMA is proposing the core recommendations outlined below.Catalysing the integration of science and technology in medicines developmentCore recommendationsSupport developmentsin precision medicine,Underlying actions Enhance early engagement with novel biomarker developers to facilitateregulatory qualification:biomarkers and ‘omics» Critically review the EMA’s biomarker validation process, includingduration and opportunities to discuss validation strategies in advance,in order to encourage greater uptake and use; Address the impact of emerging ‘omics’ methods and their applicationacross the development life cycle; Evaluate, in collaboration with HTAs, payers and patients, the impact oftreatment on clinical outcomes measured by biomarkers; Optimise the European research infrastructure for developingpersonalised medicine.Support translation Identify therapies that address unmet medical need;of advanced therapymedicinal products(ATMPs) into patient Provide assistance with early planning, method development and clinicalevaluation;treatments Address the challenges of decentralised ATMP manufacturing and deliverylocations; Support evidence generation, pertinent to downstream decision-makers;12
Support translationof advanced therapy Evaluate and improve interactions relevant to ATMPs with Europeaninstitutions (research, financial and environmental);medicinal products(ATMPs) into patienttreatments Raise global awareness of ATMPs to maximise knowledge sharing,promote data collection; Engage with other international regulatory agencies to foster globalconvergence of requirements for ATMPs.Promote and invest in Improve external communication to better explain and promote PRIME;the PRIME scheme Review the scientific advice provided in PRIME with a view to allow moreflexibility in the procedure and identify opportunities for more agilediscussions; Optimise the current regulatory system that supports PRIME in orderto enable a shortened time frame for development and MA review whileensuring high quality evidence generation plans to improve access forpatients; Review the performance of the scheme after 5 years, to ensure that itdelivers the expected impact on public health (i.e. faster access to patientsof priority medicines), and adapt its scope and features, if applicable; Explore opportunities for further engagement and collaboration withpatients, healthcare professionals, academia and international partners; Explore possible impact and benefits of expanding the earliest possibleentry to the PRIME scheme to a wider range of applicants, including fornew indications of existing products.Facilitate theimplementation of Recruit and develop expertise, in novel manufacturing technologies anddevelop training and tools to enhance the assessment process;novel manufacturingtechnologies Identify potential bottlenecks and strengthen early interaction,transparency and communication with stakeholders on regulatoryrequirements for novel manufacturing technologies; Address regulatory challenges through modernisation of relevantregulations and guidelines to facilitate novel manufacturing technologies,including through international harmonisation activities; Encourage the use of risk-based approaches to manufacturing processesand control strategies throughout the product lifecycle; Facilitate a flexible and fit for purpose approach in application of GoodManufacturing Practice; 13
Facilitate theimplementation of Support the development of greener manufacturing technologies in linewith the EU’s ‘Strategic Approach to Pharmaceuticals in the Environment’.novel manufacturingtechnologiesCreate an integratedevaluation pathway Facilitate the regulatory pathway between notified bodies and medicines’regulators:for the assessmentof medical devices, in» Establish a process for multi-stakeholder scientific advice tovitro diagnostics andsupport development of medicine-device combinations, qualificationborderline productsmethodologies and the use of companion diagnostics;» Create a process to consult medical device authorities and/or notifiedbodies (as applicable) for device-related aspects throughout theproduct lifecycle, including post-authorisation safety related events;» Adapt consultation processes to address emerging digital technologiesand wearables;Create an integratedevaluation pathway Build a network of expertise to regulate and provide support throughout theproduct lifecycle;for the assessmentof medical devices, in Define how benefit-risk of borderline products is assessed and communicated;vitro diagnostics andborderline products Gain insight in innovation on drug-device combination products via horizonscanning.Develop understanding Raise awareness of new nanomedicines and materials via the EU-of, and regulatoryInnovation Network, and foster collaboration with DG JRC and otherresponse to,international partners (e.g. IPRP), to share knowledge and harmonizenanotechnology andregulatory practices:new materials inpharmaceuticals» Generate guidance addressing PK/PD (including modelling)requirements and long-term efficacy and safety;» Develop and standardise new testing methods related to the qualityand safety assessment of nanomedicines;» Understand the critical quality attributes (CQA) of a given product andthe relationship between those and the biological activity and in-vivobehaviour of the product;Diversify and integrate Create complementary and flexible advice mechanisms to supportthe provision ofinnovative product development also expanding multi-stakeholderregulatory adviceconsultation platforms;along the developmentcontinuum14
Diversify and integrate Facilitate a more iterative advice framework that better addressesthe provision ofthe continuum of evidence generation. Make general advice on newregulatory advicetechnological trends publicly available;along the developmentcontinuum Promote more integrated medicines development aligning scientificadvice, clinical trials approval and Good Clinical Practice oversight; Advance acceptance of digital endpoints through exploring amultistakeholder platform to generate feedback on their utility; Facilitate translation of innovation via a re-engineered Innovation TaskForce and synergy with an evolving EU-Innovation Network platform.3.1.1 Support developments inprecision medicine, biomarkersand ‘omics» Critically review the EMA’s biomarkervalidation process, including duration andopportunities to discuss validation strategiesin advance, in order to encourage greaterPrecision or personalised medicines may rangeuptake and use;from targeted drugs aimed at stratified populations(biomarker-led medicine) or different stages of thedisease, to the use of individualised treatment such Address the impact of emerging ‘omics’ methods andtheir application across the development life cycle;as modified autologous cells. The development ofbiomarkers of various types, including the increasing Evaluate, in collaboration with HTAs, payersuse of ‘omics’-based biomarkers, is a key enabler ofand patients, the impact of treatment on clinicalprecision medicine.outcomes measured by biomarkers;The early involvement of stakeholders at all levelswill be key to finding solutions that allow approvedbiomarker-guided medicines to be made accessibleto patients. Regulatory assessment will need tobe further developed to deal with more comple
3. Human medicines — five strategic goals for regulatory science 10 3.1 Goal 1: Catalysing the integration of science and technology in medicines development 10 3.2 Goal 2: Driving collaborative evidence generation improving the scientific quality of evaluations 19 3.3 Goal 3: Advancing patient-centred access to medicines in partnership
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4.1 Goal 1: Catalysing the integration of science and technology in drug development 35 4.2 Goal 2: Driving collaborative evidence generation and improving . Exploit digital technology and artificial intelligence in decision making. Draft EMA Regulatory Science to 2025 3 3. Advancing patient-centred access to medicines in partnership with
Medicines Agency (EMA) launched a parallel scientific advice program in which sponsors can obtain input on value decisions from the EMA as well as various HTA bodies. The scheme was permanently implemented after the pilot ended in May 2015 due to the success of the program. The EMA or the national regulatory agencies, depending
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A formal Regulatory Management System [RMS] can help with: reduction of regulatory burden on citizens and firms improvement of regulatory quality identification of best choice of policy options Comprised of four elements: 1. regulatory quality tools 2. regulatory processes 3. regulatory institutions 4. regulatory policies 16
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These questions are provided by the EMA Licensing Branch as study material for EMA FR examinations. Please note that only 25 of the questions below will be on the EMR FR licensing and licence renewal examinations. Additionally, the questions and answers will be randomized in the examination(s). 1) A conscious patient has refused care from an EMA.
