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THE MEDICAL AFFAIRS LEXICON
TOOLKITS

The realm of medical affairs possesses its own distinct language, influencing how knowledge is genereted, communicated, and ultimately applied in clinical practice.

This lexicon has been developed as a practical resource for healthcare professionals, researchers, and individuals engaged at the intersection of medicine and the pharmaceutical industry. Its primary aim is to offer clear and consistent definitions of the key terms and abbreviations frequently encountered in medical affairs and pharmaceutical processes, fostering informed, evidence-based practices.

Each definition is anchored in authoritative sources, including EMA and FDA guidelines, ISMPP and GPP standards, ISPOR frameworks, and peer-reviewed literature.

Collectively, these resources create a valuable reference reflecting our belief that a shared understanding of medical affairs serves as the cornerstone for enhanced collaboration, stronger scientific pursuits, and ultimately, improved outcomes for patients.

All0 terms

Acceptance Rate

The proportion of manuscripts submitted to a journal that are ultimately accepted for publication, typically expressed as a percentage. Acceptance rate is one indicator (alongside impact factor and journal scope)  used to inform target journal selection within a publication plan, with lower acceptance rates generally signalling higher selectivity and, often, greater prestige. ¹

Scientific Communication

Advisory Board

A panel of key opinion leaders (advisors), who typically are physicians, researchers, or patient advocates) convened in an industry-sponsored meeting to provide strategic advice and recommendations  on clinical, scientific, or commercial questions. Advisory boards inform medical strategy, unmet needs assessments, and communication approaches without conducting research themselves. ²

Strategy & Planning

Affiliates Medical Strategy (AfM)

Country- or region-level medical strategy developed to align local affiliate activities with global objectives. AfMS documents translate the global SMP into locally relevant plans, respecting regional regulatory, cultural, and payer environments. ³

Strategy & Planning

Bibliographic Review

A structured search and summary of published literature on a defined scientific question. Unlike a systematic review, it may not follow a registered protocol or meta-analytic methodology, but provides a curated evidence base to inform strategy or communications. ⁴

Evidence & Research

Brand Plan

The core strategic and tactical document that guides all brand-related decisions and activities for a pharmaceutical product across a given period, typically annual. It is built through a structured, cross-functional process that translates market insights and situational analysis into prioritised strategic imperatives, behavioural objectives, and actionable tactics. ⁵

Strategy & Planning

Centres of Excellence

Specialized healthcare institutions, networks, or organizational units recognized for their exceptional expertise, multidisciplinary capabilities, and leadership in a specific therapeutic or scientific area. In Medical Affairs, Centres of Excellence are strategic partners for scientific collaboration, clinical research, evidence generation, medical education, and engagement with expert healthcare professionals to advance innovation and improve patient outcomes. ⁶

Strategy & Planning

Competitive Intelligence (CI)

The systematic process of collecting, analyzing, and interpreting information about competitors, products, scientific developments, market dynamics, and healthcare environments to support informed strategic decision-making. In Medical Affairs, competitive intelligence helps identify emerging scientific trends, evidence gaps, clinical developments, competitor strategies, and opportunities for differentiation while maintaining ethical standards and compliance with applicable regulations. ⁷

Strategy & Planning

Conflict of Interest (COI)

A situation where a person's personal interests (financial, professional, or otherwise) could compromise their objectivity in a scientific or clinical role. COI disclosures are required for advisory boards, publications, and educational activities to maintain transparency. ⁸

Processes & Operations

Continued Medical Education (CME)

Educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a healthcare professional uses to provide services for patients, the public, or the profession.  Financial support for CME programmes is intended to support education on a full range of treatment options and not to promote a particular medicine. ⁹

Medical Education

Delphi Process

A structured, iterative consensus methodology in which a panel of experts anonymously rate statements across multiple rounds, with controlled feedback between rounds. Widely used in medical affairs to establish clinical consensus where randomised evidence is limited, supporting guideline development and unmet needs identification. ¹⁰,¹¹

Processes & Operations

Disease Awareness

Non-promotional educational initiatives that raise understanding of a condition among healthcare professionals and/or patients; covering symptoms, diagnosis, epidemiology, and burden without referencing a specific therapy or brand. ¹²

Scientific Communication

Embargo Rules

Policies that restrict the public disclosure, distribution, or media communication of scientific information until a specified date and time, typically coinciding with the official publication of a manuscript or presentation of research findings. In Medical Affairs, embargo rules ensure that unpublished or accepted scientific data are communicated consistently, ethically, and in compliance with journal, congress, and regulatory requirements, preventing premature dissemination of results while allowing coordinated scientific exchange after the embargo is lifted. ¹³

Scientific Communication

European Medicines Agency (EMA)

The EU regulatory agency responsible for the scientific evaluation, supervision, and safety monitoring of medicines. Medical affairs teams engage with EMA processes during regulatory submissions, label negotiations, and post-approval commitments. ¹⁴

Processes & Operations

Evidence Gap

An identified absence of data needed to answer a clinical or scientific question (for instance, a lack of head-to-head comparative data or long-term outcomes evidence). Mapping evidence gaps drives medical research and data generation strategies. ¹⁵

Evidence & Research

Expanded Access Program (EAP)

A regulatory pathway, also known as "compassionate use," that allows patients with serious or life-threatening conditions to access an investigational medicine outside of a clinical trial when no comparable approved therapy is available. EAPs are governed by FDA and EMA regulations and require demonstration that the potential benefit justifies the risk. ¹⁶,¹⁷

Processes & Operations

Focus Group

A qualitative market research method in which a small, purposefully selected group of participants ( such as HCPs or patients) discuss their perceptions, attitudes, or experiences in a moderated setting. In medical affairs, focus groups inform content development, message testing, and understanding of unmet needs. ¹⁸

Processes & Operations

GAP Analysis

A structured assessment comparing the current state of available evidence, perceptions, or capabilities against a desired or required state. In medical affairs, gap analyses identify unmet informational needs among HCPs, publication voids, or inconsistencies between clinical data and clinical practice. ¹⁹

Strategy & Planning

Global Value Dossier (GVD)

A comprehensive, structured core document compiling all clinical, economic, and patient-reported evidence for a medicine. The GVD is the master evidence repository used to support HTA submissions, market access, and pricing decisions. ²⁰

Evidence & Research

Health Economics and Outcomes Research (HEOR)

Research that evaluates the clinical, economic, and patient-centred outcomes of healthcare interventions. HEOR evidence including cost-effectiveness models, quality of life data, and budget impact analyses. This supports market access, payer negotiations, and formulary decision. ²¹

Evidence & Research

Health Technology Assessment (HTA)

A systematic, multidisciplinary evaluation of the properties, impact, and broader implications of health technologies and interventions (such as biopharmaceuticals, medical devices, and diagnostics). HTA assesses both the direct and indirect consequences of an asset, aiming to determine its value and inform how it can be adopted within health systems. Hence, it directly influences pricing and reimbursement decisions across markets. ²²,²³

Processes & Operations

Healthcare Professional (HCP)

Any licensed professional involved in the delivery of patient care (including physicians, nurses, pharmacists, and allied health professionals). Medical affairs teams engage HCPs through medical education, scientific exchange, advisory boards, and MSL interactions. ²⁴

Processes & Operations

Impact Factor (IF)

A bibliometric indicator that measures the average number of citations received in a given year by articles published in a scientific journal during the preceding two years. Calculated annually in the Journal Citation Reports (JCR), the Impact Factor is widely used to assess the relative influence and visibility of journals. In Medical Affairs, it is commonly considered when evaluating the scientific reach of publications, although it should not be used as the sole indicator of research quality or individual article impact. ²⁵

Scientific Communication

Independent Medical Education (IME)

Educational programmes for healthcare professionals that are developed and delivered independently of pharmaceutical industry promotional objectives. IME may receive industry grants but must demonstrate independence in content development and faculty selection. ²⁴,²⁶

Medical Education

Integrated Evidence Generation Plan (iEGP)

A cross-functional strategic framework that plans and coordinates evidence activities across a product's entire lifecycle. It identifies evidence needed to address clinical, scientific, regulatory, health economic, payer, and patient evidence gaps. The ultimate goal is to support regulatory decisions, clinical practice, reimbursement, and to ensure optimal patient care. ²⁷

Evidence & Research

Integrated Product Strategy (IPS)

A cross-functional strategic framework that aligns the long-term objectives, priorities, and activities of multiple functions across the product lifecycle, including Medical Affairs, Clinical Development, Regulatory Affairs, Market Access, and Commercial teams. In Medical Affairs, an Integrated Product Strategy ensures that scientific, clinical, and business priorities are coordinated to support evidence generation, stakeholder engagement, patient value, and successful product development and lifecycle management. ²⁸

Strategy & Planning

Intellectual Property (IP)

Legal rights that protect creations of the mind, including inventions, scientific discoveries, publications, trademarks, designs, and other forms of proprietary knowledge. In Medical Affairs and the pharmaceutical industry, intellectual property considerations are relevant to protecting innovations, managing data ownership, publications, scientific assets, and collaborations while ensuring appropriate use and dissemination of scientific information throughout the product lifecycle. ²⁹

Strategy & Planning

Investigator-Initiated Study / Research (IIS/IISR)

A clinical or observational study designed, initiated, and conducted by an external investigator rather than a pharmaceutical company. Companies may provide financial or material support. IIS/IISRs can generate valuable RWE and expand the evidence base beyond sponsored trials. ⁹,²⁴

Evidence & Research

Joint Clinical Assessment

An EU-level procedure under the HTA Regulation (EU) 2021/2282 in which Member State HTA bodies jointly assess the clinical evidence of a medicinal product. It is anchored to EMA's centralised marketing authorisation procedure, resulting in a single assessment report used across Member States in national HTA and reimbursement decision-making processes, avoiding duplication of clinical assessment work at national level. ³⁰

Processes & Operations

Joint Scientific Consultation

The early-stage scientific advice procedure under the EU HTA Regulation, conducted between a health technology developer (HTD) and HTA bodies before the formal JCA, typically during clinical development. It allows the HTD to seek joint scientific advice on the design of clinical trials and the evidence generation plan intended to support a future JCA. It is led by an assessor and co-assessor appointed from the HTA Coordination Group's subgroup, distinct from those later appointed to the JCA of the same technology. ³¹

Processes & Operations

Key Opinion Leader (KOL)

A respected expert in a therapeutic area whose opinions and clinical practice significantly influence peers. Medical affairs teams engage KOLs for advisory boards, speaker programmes, clinical research collaborations, and publication authorship. Modern engagement also includes Emerging Thought Leaders (ETLs) and Digital Opinion Leaders (DOLs). KOLs may be further classified into Tier 1, Tier 2, Tier 3, and Rising Stars, according to their level of influence and expertise. The definitions and criteria for each category are provided in subsequent sections of this lexicon. ³²,³³

Strategy & Planning

KOL Rising Star

An emerging healthcare professional, researcher, or scientific expert who demonstrates growing expertise, academic potential, and increasing recognition within a specific therapeutic area, despite not yet having the established influence of senior experts or traditional Key Opinion Leaders (KOLs). In Medical Affairs, Rising Stars are identified as future scientific leaders and may be engaged through mentorship, scientific exchange, investigator opportunities, advisory activities, and educational initiatives to support long-term external expert relationships. ³³

Scientific Communication

KOL Tier 1

Highly recognized healthcare professionals or scientific experts who are considered leading authorities in a specific therapeutic area due to their expertise, research contributions, publications, clinical experience, academic influence, or leadership roles within the scientific community. In Medical Affairs, Tier 1 KOLs are often prioritized for strategic scientific engagement, advisory boards, investigator collaborations, peer-to-peer education, and evidence-generation initiatives based on their influence and expertise rather than commercial value. ³³

Scientific Communication

KOL Tier 2

Healthcare professionals or scientific experts with recognized expertise and influence within a specific therapeutic area, but with a more regional, emerging, or specialized level of recognition compared with Tier 1 KOLs. In Medical Affairs, Tier 2 KOLs are important stakeholders for scientific exchange, regional insights, investigator networks, advisory activities, and medical education initiatives, often representing future scientific leaders or influential experts within specific healthcare communities. ³³

Scientific Communication

KOL Tier 3

Healthcare professionals or subject matter experts with developing or more localized influence within a therapeutic area, often recognized for clinical expertise, participation in research activities, institutional roles, or contributions to local scientific communities. In Medical Affairs, Tier 3 KOLs are engaged to support scientific exchange, gather field insights, identify emerging expertise, contribute to education initiatives, and help expand networks of future scientific leaders. ³³

Scientific Communication

Level of Evidence (LOE)

A hierarchical ranking system that classifies the quality and reliability of clinical evidence, from systematic reviews and RCTs at the top through observational studies to expert opinion at the base. LOE frameworks (e.g., Oxford CEBM, GRADE) guide the strength of recommendations in clinical guidelines. ³⁴

Evidence & Research

Licensing agreement

A legally binding agreement in which the owner of intellectual property (the licensor) grants another party (the licensee) the rights to use, develop, manufacture, commercialize, or otherwise exploit a specific asset under defined terms and conditions. In Medical Affairs and the pharmaceutical industry, licensing agreements are strategic collaborations that may enable access to compounds, technologies, data, or scientific platforms, while defining responsibilities related to development activities, evidence generation, regulatory interactions, publication rights, and commercialization strategies. ³⁵

Strategy & Planning

Marketing Authorisation Application (MAA)

A formal regulatory submission made by a pharmaceutical company or applicant to a regulatory authority requesting approval to market a medicinal product for a specific indication. The MAA contains comprehensive documentation on the product’s quality, safety, efficacy, manufacturing processes, and benefit–risk profile, based on preclinical and clinical evidence. In Medical Affairs, the MAA process is relevant for ensuring scientific alignment, supporting regulatory interactions, contributing to evidence-generation strategies, and preparing medical information activities throughout the product approval lifecycle. ³⁶

Processes & Operations

Medical Affairs Plan

A tactical document detailing specific medical affairs activities, timelines, budgets, and KPIs for a defined period. The MA Plan operationalises the Strategic Medical Plan and tracks delivery against objectives. ³⁷,³⁸

Strategy & Planning

Medical Governance

The framework of structures, processes, policies, and oversight mechanisms that ensure Medical Affairs activities are conducted with scientific integrity, ethical standards, compliance requirements, and alignment with organizational objectives. In Medical Affairs, medical governance defines roles and responsibilities, decision-making processes, cross-functional collaboration, review pathways, and quality standards to ensure appropriate management of scientific exchange, evidence generation, medical education, and stakeholder engagement activities. ³⁹,⁴⁰

Processes & Operations

Medical Science Liaison (MSL)

A field-based medical affairs professional who engages in non-promotional, scientific exchange with healthcare professionals, KOLs, and payers. MSLs gather field insights, disseminate clinical data, support investigator-initiated research, and serve as the scientific interface between the company and the external medical community. ⁴³

Strategy & Planning

Medical, Legal & Regulatory Review (MLR)

A cross-functional review process that evaluates medical, promotional, and educational materials before external use. MLR ensures that all content is scientifically accurate, legally compliant, and meets regulatory requirements. Also referred to as PRC or MRC in some organisations. ⁴¹,⁴²

Processes & Operations

Meta-Analysis

A statistical technique that combines data from multiple independent studies to produce a pooled estimate of effect size with greater power than any single study. Meta-analyses typically accompany systematic reviews and represent the highest tier of quantitative evidence. ⁴⁴

Evidence & Research

Narrative Review

A broad, non-systematic overview of the literature on a topic, organised around a clinical or scientific theme. Narrative reviews synthesise evidence from the author's perspective and are less rigorous than systematic reviews but useful for educational and communication purposes. ⁴⁵

Evidence & Research

New Drug Application (NDA)

A formal application submitted to the U.S. Food and Drug Administration requesting approval to market a new pharmaceutical product in the United States. The NDA contains comprehensive data on the drug’s chemistry, manufacturing, pharmacology, clinical efficacy, safety, labeling, and proposed use to demonstrate that the product is safe and effective for its intended indication. In Medical Affairs, the NDA process is relevant for supporting evidence review, scientific data generation, regulatory strategy alignment, and preparation of medical activities before and after product approval. ⁴⁶

Processes & Operations

Off-label drug use

The use of an approved medicinal product in a way that differs from the terms of its regulatory authorization, such as use in a different indication, patient population, dosage, route of administration, or duration of treatment than those specified in the approved product label. In Medical Affairs, off-label use requires balanced, scientifically accurate, and non-promotional communication of available evidence, while ensuring compliance with applicable regulatory requirements and ethical standards. ⁴⁷

Processes & Operations

Open-Access Publishing

A publishing model that provides unrestricted online access to scientific articles and research outputs, allowing readers to access, read, and often reuse published content without subscription barriers. In Medical Affairs, open access publishing facilitates broader dissemination of scientific evidence, increases accessibility for healthcare professionals and researchers, and supports transparent communication of clinical and scientific findings while following applicable publication ethics and copyright requirements. ⁴⁸,⁴⁹

Scientific Communication

Over-the-counter drugs (OTC Drugs)

Medicinal products that can be obtained by patients without a prescription from a healthcare professional and are approved for use based on established safety, efficacy, and appropriate self-management criteria. OTC medicines are typically used for conditions that patients can diagnose and manage themselves, when used according to approved labeling and instructions. In Medical Affairs, OTC drugs require appropriate scientific communication, medical information support, safety monitoring, and evidence-based education to ensure correct use and responsible patient self-care. ⁵⁰

Processes & Operations

Patient Advocacy Groups (PAGs)

Organizations that represent and support the interests, needs, and perspectives of patients, caregivers, and communities affected by specific diseases or health conditions. In Medical Affairs, engagement with Patient Advocacy Groups helps incorporate the patient voice into healthcare strategies, identify unmet needs, support patient-centric evidence generation, improve disease awareness and education, and inform activities across the product lifecycle while maintaining transparency and ethical standards. ⁵¹,⁵²

Strategy & Planning

Patient Journey

A structured mapping of a patient's experience from first symptoms through diagnosis, treatment, ongoing management, and outcomes. Patient journeys identify barriers, delays, and unmet needs at each stage, informing medical strategy, HCP education, and value communication. ⁵³

Strategy & Planning

Patient-Reported Outcomes (PRO)

Any report on a patient's health status, symptoms, functioning, or quality of life that comes directly from the patient without clinician interpretation. PRO instruments are increasingly required by regulators and HTA bodies as endpoints in clinical trials. ⁵⁴

Evidence & Research

Payers

Organizations or entities responsible for financing, reimbursing, or determining coverage of healthcare services, treatments, and medicines, including public health systems, private insurance companies, and other healthcare financing bodies. In Medical Affairs, payers are key healthcare stakeholders whose evidence needs may include clinical outcomes, real-world evidence, health economics, and patient value data to support informed decisions regarding access, reimbursement, and healthcare resource allocation. ⁵⁵

Strategy & Planning

Peer Review

A critical evaluation process in which independent experts with relevant scientific or clinical expertise assess the quality, validity, originality, methodology, and relevance of scholarly work before publication or dissemination. In Medical Affairs, peer review supports the credibility and integrity of scientific communications by ensuring that publications, abstracts, manuscripts, and other evidence-generation outputs meet appropriate scientific and ethical standards. ⁵⁶

Scientific Communication

Population, Intervention, Comparator, Outcome (PICO)

A framework used to formulate answerable clinical questions and structure systematic literature searches. Defining PICO elements at the outset of a review ensures the evidence gathered is relevant to the clinical or reimbursement question being addressed. ⁵⁷

Evidence & Research

Post Launch

The phase of a product’s lifecycle that begins after regulatory approval and market introduction, focusing on activities required to support optimal adoption, generate additional evidence, monitor safety and effectiveness, and address evolving stakeholder needs. In Medical Affairs, the post-launch phase includes ongoing evidence generation (such as real-world evidence), scientific engagement with healthcare professionals, medical education, publication planning, and lifecycle management strategies to support appropriate use and continued patient benefit. ⁵⁸

Strategy & Planning

Preceptorship

An experiential, mentorship-based educational model in which a healthcare professional spends dedicated time with an experienced expert to observe and practise clinical techniques or decision-making in a real-world setting. Preceptorships are used to build clinical skills in complex procedures, specialist assessments, or diagnostic approaches. ⁵⁹,⁶⁰

Medical Education

Premarket approval (PMA)

A regulatory approval process required by the U.S. Food and Drug Administration for certain high-risk medical devices before they can be marketed in the United States. The PMA application requires comprehensive scientific evidence, including clinical data, to demonstrate the safety and effectiveness of the device for its intended use. In Medical Affairs, PMA-related activities involve supporting evidence generation, clinical data interpretation, scientific exchange, and preparation of medical strategies aligned with regulatory requirements and product lifecycle management. ⁶¹

Processes & Operations

Product Life Cycle

The progression of a healthcare product through the different stages from initial development and regulatory approval to launch, growth, maturity, and eventual decline or lifecycle extension. In Medical Affairs, product lifecycle management involves strategic planning of evidence generation, scientific communication, stakeholder engagement, medical education, and real-world evidence activities to address evolving scientific, clinical, and healthcare needs throughout the product’s lifespan. ⁶²

Strategy & Planning

Publication Plan

A strategic document outlining the planned dissemination of clinical and scientific data through peer-reviewed journals, congress presentations, and other channels. A publication plan aligns with the scientific communication platform and evidence generation strategy to ensure timely, ethical, and complete disclosure of data. ⁶³

Scientific Communication

Real-World Data (RWD)

Data relating to patient health status and healthcare delivery collected from routine clinical practice sources (including electronic health records, claims databases, patient registries, and wearable devices) outside the controlled setting of a clinical trial. ⁶⁴

Evidence & Research

Real-World Evidence (RWE)

Clinical evidence about the usage, potential benefits, or risks of a medical product derived from analysis of RWD. RWE is increasingly accepted by regulators and HTA bodies to complement randomised trial data, particularly for rare diseases, long-term outcomes, and comparative effectiveness. ⁶⁴

Evidence & Research

Reimbursement

The process by which healthcare providers, patients, or organizations receive financial compensation for healthcare products, services, or treatments through public healthcare systems, private insurers, or other healthcare financing mechanisms. In Medical Affairs, reimbursement considerations involve generating and communicating relevant clinical, economic, and real-world evidence to demonstrate the value of a therapy and support healthcare decision-making, access strategies, and payer discussions. ⁶⁵

Strategy & Planning

Roundtable

A structured, discussion-based educational or scientific exchange format in which a small group of experts and stakeholders engage in open dialogue around a defined clinical or scientific topic, typically without a single presenting authority. Roundtables encourage multidirectional knowledge exchange rather than one-way presentation. ⁶⁶

Medical Education

Satellite Symposium

A scientific educational session organized by a pharmaceutical company or other healthcare organization in conjunction with a major medical congress, but held separately from the official congress scientific program. Satellite symposia provide a platform for scientific exchange, discussion of emerging data, and education on therapeutic areas or clinical topics involving healthcare professionals and scientific experts. ⁶⁷

Medical Education

Scientific Communication Platform (SCP)

A strategic framework that defines the core scientific narrative and key messages for a medicine or therapeutic area. The SCP ensures consistency across all communication channels (e.g., publications, congress presentations, HCP materials, and MSL interactions) and is aligned with the overall medical and commercial strategy. ⁶⁸

Scientific Communication

Scottish Intercollegiate Guidelines Network (SIGN) Methodology

A rigorous, evidence-based approach to clinical guideline development. SIGN methodology employs systematic literature reviews, explicit grading of evidence quality, and structured consensus processes to develop recommendations. ⁶⁹

Evidence & Research

Slide Deck

A structured presentation of clinical or scientific data, typically in PowerPoint format, used by MSLs, medical affairs teams, or faculty speakers for HCP education. Slide decks must pass MLR review and are categorised as either approved for reactive use or as part of a proactive communication plan. ⁷⁰

Scientific Communication

Standard Operating Procedure (SOP)

A documented, step-by-step process that standardises how a specific task or activity is performed within an organisation. In pharma and medical affairs, SOPs govern critical processes such as MLR review, adverse event reporting, MSL interactions, and data disclosure in order to ensure compliance and consistency. ⁷¹

Processes & Operations

Strategic Insights

Actionable understanding derived from the systematic collection, analysis, and interpretation of scientific, clinical, healthcare, and stakeholder information to guide strategic decision-making. In Medical Affairs, strategic insights are generated from interactions with healthcare professionals, external experts, patients, scientific literature, real-world evidence, and healthcare trends to identify unmet needs, evidence gaps, opportunities, and priorities for medical strategy development and execution. ⁷³

Strategy & Planning

Strategic Medical Plan (SMP)

The overarching document that defines medical affairs objectives, priorities, target audiences, key scientific questions, and planned activities for a medicine across its lifecycle. The SMP is aligned with the brand strategic plan and drives all downstream medical affairs activities including evidence generation, publication strategy, and medical education. ⁷²

Strategy & Planning

Strengths, Weaknesses, Opportunities, Threats (SWOT) Analysis

A strategic analysis framework used to evaluate internal capabilities (strengths and weaknesses) and the external environment (opportunities and threats) in relation to a medicine, therapeutic area, or competitor landscape. In medical affairs, SWOT analyses inform the SMP and help prioritise where scientific resources should be deployed. ⁷⁴

Strategy & Planning

Symposium

Educational event held by the association sponsoring the congress or conference. The same association conducts and oversees the symposium. The association may ask for applications from cosponsors to encourage new ideas and topics of interest. ⁷⁵

Medical Education

Systematic Review

A rigorous, pre-registered synthesis of all available evidence on a specific clinical question, following explicit, reproducible methodology to identify, select, and critically appraise relevant studies. Systematic reviews represent the gold standard for evidence synthesis and are foundational for guideline development and HTA submissions. ⁷⁶

Evidence & Research

Unmet Medical Need (UMN)

A clinical condition or patient population for which current available therapies are absent, insufficient, or associated with unacceptable safety profiles. Identifying and articulating unmet medical needs is central to medical affairs strategy, clinical development planning, and regulatory and market access discussions. ⁷⁷

Strategy & Planning

Webinar

A live or on-demand educational session delivered through digital platforms that enables remote participation and interaction between presenters and an audience. In Medical Affairs, webinars are used as tools for scientific exchange, healthcare professional education, dissemination of clinical evidence, and discussion of therapeutic advances, while requiring appropriate content governance, scientific balance, and compliance with applicable regulations and industry standards. ⁷⁸

Medical Education

White Paper

A comprehensive, authoritative document that presents expert analysis, evidence, perspectives, or recommendations on a specific scientific, clinical, technical, or healthcare topic. In Medical Affairs, white papers are used to communicate complex scientific concepts, summarize evidence, address unmet needs, support scientific discussions with stakeholders, and provide educational resources based on available data and expert consensus. ⁷⁹

Scientific Communication
No glossary terms found.

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