Pharmacovigilance in Older People: Geriatric Considerations

Introduction

Older people are major users of medicines, but age alone does not define their pharmacovigilance risk. The relevant clinical context may include multimorbidity, polypharmacy, frailty, altered renal or hepatic function, changes in pharmacodynamic sensitivity, cognitive impairment and differences in how medicines are administered and monitored.

These factors can interact. An adverse event may be caused by the medicinal product, by another medicine, by the underlying disease, by a drug interaction, by an administration problem or by a combination of these factors. Age may increase susceptibility without being the direct cause of the event.

The purpose of geriatric pharmacovigilance is therefore to determine whether safety information has a different meaning in older people and, where it does, whether the difference requires additional investigation, risk management, communication or regulatory action.

EMA's geriatric medicines strategy aims to ensure that medicines used by older people are appropriately researched and evaluated throughout the product lifecycle, and EMA continues to maintain guidance and initiatives addressing older populations. citeturn1search1

1. Regulatory and Scientific Framework

There is not a separate final GVP product- or population-specific chapter for older people equivalent to the current vaccine, biological, pregnancy/breastfeeding and paediatric considerations. EMA's current GVP page identifies those final considerations and does not list a dedicated geriatric GVP chapter. citeturn0search0

Geriatric pharmacovigilance should therefore be understood through the general EU pharmacovigilance framework together with scientific guidance addressing older populations. Relevant material includes ICH E7 on studies in support of special populations, EMA's geriatric medicines strategy and its reflection paper on pharmaceutical development for medicines used in the older population. citeturn1search9turn1search1turn1search0

This distinction matters for regulatory writing. The specific geriatric considerations discussed in this article are not presented as requirements of a nonexistent GVP Module V or other dedicated geriatric module. They are scientific and operational considerations that may be relevant when applying the general pharmacovigilance framework to older patients.

2. Why Age Changes the Safety Context

Physiological ageing can alter exposure and response to medicines, but the magnitude and clinical relevance vary substantially between individuals.

Renal function, hepatic function, body composition, cardiovascular reserve, neurological function and other physiological characteristics may change with age. These changes can influence pharmacokinetics or pharmacodynamics and can modify the consequences of a given exposure.

Age should therefore be treated as a potential effect modifier rather than as a simple explanation for an adverse event.

3. Older People Are Not a Homogeneous Population

An 80-year-old person who is independent and has few comorbidities may have a very different safety profile from a similarly aged person with frailty, renal impairment and multiple chronic medicines.

Chronological age is consequently only one dimension of geriatric assessment. Functional status, comorbidity, cognitive status, nutritional status and treatment burden may be more informative for a particular safety question.

A pharmacovigilance analysis that treats all older patients as one homogeneous subgroup may therefore miss clinically meaningful differences or create apparent associations that are actually caused by differences in patient characteristics.

4. Frailty

Frailty describes reduced physiological reserve and increased vulnerability to stressors. It can alter the consequences of an adverse event even when the probability of the event itself is unchanged.

For example, a medicine-associated fall may have substantially greater consequences in a frail older person than in a robust older adult. Similarly, a modest physiological disturbance may precipitate hospitalisation or functional decline in a patient with limited reserve.

Frailty should therefore be considered both when assessing susceptibility and when evaluating clinical seriousness.

5. Multimorbidity

Older patients frequently have several diseases requiring simultaneous treatment. This creates competing explanations for symptoms and adverse events.

A new symptom may represent progression of one disease, manifestation of another condition, an adverse drug reaction or an interaction between treatment and disease.

The safety assessment should therefore reconstruct the clinical context rather than attributing every new event to the most recently prescribed medicine.

6. Polypharmacy

Polypharmacy increases the number of potential interactions and can make causal attribution difficult.

The relevant issue is not simply the number of medicines. The pharmacological characteristics of the combination, therapeutic margins, dosing schedules, organ function and duration of treatment all influence risk.

When assessing an adverse event in an older patient, concomitant medicines should be considered as potential causes, contributors, modifiers and alternative explanations.

7. Prescribing Cascades

A prescribing cascade can occur when an adverse effect of one medicine is interpreted as a new medical condition and another medicine is prescribed to treat it.

The additional medicine can then produce further adverse effects, creating a chain that obscures the original cause.

From a pharmacovigilance perspective, recognising such patterns can be important because the clinically relevant safety problem may involve the interaction between treatment decisions rather than one isolated adverse reaction.

8. Renal Function

Renal function is particularly important for medicines that are substantially eliminated through the kidneys or whose active metabolites accumulate with impaired clearance.

Serum creatinine alone may not fully represent renal function in an older person, particularly where muscle mass is reduced. The appropriate measure depends on the clinical and scientific context.

A safety assessment should therefore consider whether the patient's renal function was appropriate for the medicine and dose at the time of exposure.

9. Hepatic Function

Ageing and disease can also affect hepatic drug handling, although the relationship is complex and cannot be reduced to chronological age.

Liver disease, reduced hepatic blood flow and changes in metabolic capacity may alter exposure for particular medicines. Concomitant medicines may further modify metabolism or transport.

The presence of older age should therefore prompt consideration of hepatic factors when clinically relevant, not an automatic assumption of hepatic impairment.

10. Pharmacodynamic Sensitivity

Older patients may have altered sensitivity to some pharmacological effects even when plasma exposure is similar.

This can be particularly relevant to medicines affecting the central nervous system, cardiovascular system, coagulation, blood pressure or other physiological functions.

A safety signal may therefore appear in older people because the consequences of a given pharmacological effect are different, rather than because the medicine produces a qualitatively new adverse reaction.

11. Falls and Functional Outcomes

Falls are clinically important in older populations and may have multiple contributing causes.

Medicines can contribute through sedation, dizziness, orthostatic effects, impaired coordination or other mechanisms. At the same time, frailty, neurological disease, environmental factors and visual impairment may contribute independently.

A fall report should therefore be assessed for its mechanism and context rather than treated as evidence of a single medicine-specific effect.

12. Cognitive and Neuropsychiatric Events

Changes in cognition, confusion, delirium or behavioural symptoms may be difficult to distinguish from manifestations of underlying neurological disease.

The timing of the event, baseline cognitive status, concomitant medicines, acute illness and other precipitating factors can be important.

Where a potential medicine-related cognitive effect is identified, the assessment should determine whether the phenotype and chronology support a plausible association.

13. Medication Errors

Medication errors can become more likely or more consequential when treatment involves complex regimens, visual impairment, cognitive impairment, dexterity limitations or multiple caregivers.

Errors may involve selection, dose, timing, preparation, administration or adherence. The resulting event should be investigated to determine whether the underlying problem concerns the medicinal product, its presentation or the medication-use system.

EMA's work on medicines for older people specifically recognises medication-management and usability issues as relevant considerations. citeturn1search0

14. Adherence and Medicine Management

Adherence in older people can be affected by regimen complexity, cognitive impairment, swallowing difficulties, cost, social circumstances and the number of medicines taken.

Poor adherence can lead to loss of disease control and may be mistaken for lack of efficacy or a new safety problem. Conversely, accidental duplication or incorrect dosing can increase exposure.

The safety assessment should therefore consider how the medicine was actually used rather than relying solely on the intended prescription.

15. Formulation and Usability

The formulation can influence safety independently of the pharmacological properties of the active substance.

Difficult-to-open containers, unclear instructions, inappropriate measuring devices, large tablets or complex administration procedures may increase the risk of medication errors.

EMA's reflection paper encourages patient-centric pharmaceutical development for older people, including consideration of dosage forms, dosing frequency, devices, technologies and user instructions. citeturn1search0

16. Atypical Presentation of Adverse Reactions

An adverse drug reaction in an older person may present differently from the expected textbook phenotype.

For example, a medicine-related problem may manifest as weakness, confusion, reduced mobility, functional decline or a fall rather than as a symptom explicitly recognised as an adverse reaction.

This creates a detection challenge because the clinical event may be recorded under a broad or non-specific term.

17. Background Risk

Many events relevant to older patients have substantial background incidence.

Falls, renal dysfunction, delirium, cardiovascular events and cognitive changes may occur without medicine exposure. An increase in reports therefore requires comparison with appropriate clinical and epidemiological context where feasible.

A high reporting frequency in an older population does not by itself establish an increased medicine-related risk.

18. The Core Assessment Question

The central question in geriatric pharmacovigilance is not simply whether an event occurred after exposure.

It is whether the evidence indicates that the medicinal product caused, contributed to or materially modified the event, and whether that relationship differs in older patients in a clinically meaningful way.

This requires integration of exposure, chronology, concomitant treatment, comorbidity, organ function, frailty, biological plausibility and relevant population evidence.

19. Detecting Age-Related Safety Patterns

Age-specific analysis can be useful when there is a plausible reason to expect differences in susceptibility, exposure or clinical presentation.

The choice of age categories should follow the safety question. Excessive subdivision can produce unstable results, while analysing all adults together can obscure a clinically important pattern in older patients.

The objective is not to prove that age causes the difference. It is to determine whether the observed pattern warrants further assessment.

20. Exposure and Denominator Problems

Spontaneous reports generally do not provide a reliable denominator for estimating incidence.

This is particularly important in older populations because medicine use, comorbidity and healthcare contact may be greater than in younger populations. A larger number of reports may therefore reflect greater exposure or reporting opportunity rather than greater relative risk.

Where quantitative inference is required, exposure estimates and an appropriate comparison population should be considered.

21. Signal Validation in Older Patients

A potential geriatric signal should be validated using the same fundamental principles applied elsewhere in pharmacovigilance, while incorporating the clinical factors that are particularly relevant to older patients.

The assessment should consider the quality of cases, chronology, dose, indication, concomitant medicines, organ function, frailty, alternative explanations and relevant background risk.

A cluster of events in older people should not automatically be interpreted as an age-specific drug effect.

22. Confounding by Indication

The diseases for which medicines are prescribed may themselves be more common or more severe in older populations.

An association between a medicine and an outcome may therefore reflect the underlying indication rather than the medicine. This is especially relevant when the outcome is also a complication of the disease being treated.

The safety assessment should consider whether the observed pattern is compatible with confounding by indication and whether comparative evidence can address the question.

23. Confounding by Frailty

Frailty can influence both medicine exposure and the probability of an adverse outcome.

A frail patient may receive more medicines, have more healthcare contacts and be more likely to experience serious outcomes. These relationships can create an apparent association even when the medicine is not the principal cause.

Frailty should therefore be considered where it is relevant to the exposure-outcome relationship.

24. Drug-Drug Interactions

Polypharmacy increases the opportunity for pharmacokinetic and pharmacodynamic interactions.

The clinical importance of an interaction depends on the specific medicines, doses, timing, organ function and therapeutic margin. A theoretical interaction is not automatically a clinically significant interaction.

When an adverse event occurs in a patient receiving several medicines, the complete exposure pattern should be reconstructed before assigning causality.

25. Drug-Disease Interactions

A medicine may worsen an underlying condition or interact with a physiological vulnerability without producing a conventional adverse reaction phenotype.

For example, treatment may alter blood pressure, renal function, electrolyte balance or cognitive status in a patient whose reserve is already limited.

The safety assessment should therefore consider whether the medicine modified the course of an underlying condition.

26. Therapeutic Competition

Older patients may have several clinically important conditions competing for treatment priorities.

A medicine may reduce one risk while increasing another. A treatment decision that appears undesirable when one outcome is considered in isolation may be reasonable in the broader clinical context.

Pharmacovigilance should identify and characterise safety risks; the resulting regulatory and clinical decisions require consideration of the overall benefit-risk balance.

27. Dechallenge and Rechallenge

Changes after discontinuation or reintroduction can provide useful evidence in individual cases when the clinical circumstances permit interpretation.

However, dechallenge and rechallenge evidence may be confounded by changes in other medicines, disease activity, supportive treatment or exposure.

The absence of improvement after discontinuation does not necessarily exclude a medicine-related contribution, particularly where the event is irreversible or the medicine has a long biological effect.

28. Seriousness and Consequence

An event's seriousness should be distinguished from the magnitude of its functional consequence.

A fall that does not initially meet a conventional seriousness criterion may nevertheless represent an important safety concern if it contributes to loss of independence. Conversely, a hospitalisation may occur for reasons unrelated to the medicinal product.

The assessment should therefore consider the actual clinical consequences and the applicable regulatory seriousness criteria separately.

29. Hospitalisation and Transitions of Care

Transitions between primary care, hospital care, rehabilitation and residential settings can create gaps in medication information.

Discrepancies in medication lists may produce duplication, omission or unintended continuation of therapy. These events may subsequently appear as adverse drug reactions unless the medication history is reconstructed accurately.

Pharmacovigilance investigations should therefore consider transitions of care when medication-use errors are suspected.

30. Polypharmacy and Signal Attribution

When many medicines are taken simultaneously, assigning a single suspect product can be scientifically difficult.

The appropriate response is not to assign causality to every medicine equally. Instead, the assessment should compare the pharmacological plausibility, timing, dose relationship, known safety profile and alternative explanations for each relevant exposure.

The resulting uncertainty should be recorded where attribution remains incomplete.

31. Clinical Studies in Older People

Clinical trials provide controlled evidence but older patients may be under-represented or may differ from the broader population who ultimately receives the medicine.

ICH E7 provides guidance for the clinical evaluation of medicines in geriatric populations, including considerations relating to pharmacokinetics, pharmacodynamics, dose response and drug-drug interactions. citeturn1search9

Post-authorisation pharmacovigilance is consequently important for determining whether the safety profile observed in trials remains applicable to older people in routine practice.

32. Real-World Evidence

Electronic health records, prescription databases, registries and other real-world sources can provide information on medicine use, safety and effectiveness in older populations.

EMA's current geriatric programme includes evidence-generation work examining medicine use, safety and effectiveness in older people, including frailty and comorbidity. citeturn1search1

The usefulness of such data depends on exposure ascertainment, outcome definition, confounding control, completeness and the ability of the dataset to answer the specific safety question.

33. Signal Detection and EudraVigilance

EudraVigilance is an important source of suspected adverse-reaction information for EU signal management, but a signal identified in older patients still requires scientific assessment.

EMA explicitly notes that the presence of a safety signal does not mean that the medicine caused the reported event; alternative explanations include the underlying illness or another medicine. citeturn1search7

Age-specific findings should therefore enter the same controlled signal-management framework while receiving the geriatric clinical interpretation needed for the question.

34. Aggregate Safety Evaluation

Geriatric safety findings may become relevant to PSURs and other aggregate evaluations when they materially affect the understanding of the benefit-risk profile.

The assessment should determine whether the evidence represents a new risk, a new aspect of a known risk, a change in frequency or severity, or a difference in clinical presentation in older patients.

A higher absolute number of reports in older people is not by itself sufficient to establish any of these conclusions.

35. Risk Management

If evidence indicates that a risk is particularly important in older people, risk-management measures should address the specific mechanism of risk.

Possible interventions may concern monitoring, prescribing, dosing, contraindications, warnings, medication-use processes or targeted communication. The selected measure should follow the safety objective rather than simply being labelled a "geriatric" intervention.

EMA notes that, when evaluating medicines, specific activities concerning comorbidities and monitoring of side effects in older patients may be considered for inclusion in risk-management plans or as post-authorisation measures. citeturn1search1

36. Product Information

Where the evidence supports a change to product information, the regulatory assessment should determine the appropriate wording and scope.

Information concerning older patients may need to address dose adjustment, contraindications, warnings, monitoring or other clinically relevant factors. The presence of an age-related concern does not automatically imply that a new warning is required.

The wording should remain proportional to the evidence and consistent with the regulatory conclusion.

37. Communication With Older Patients

Safety information should be communicated in a form that older patients can understand and use.

Visual impairment, hearing impairment, cognitive impairment and health literacy can affect how information is received. Where caregivers or other support persons are involved in medication management, they may also need access to relevant information.

The objective is accurate understanding of the safety issue and appropriate action, not simply distribution of written material.

38. Communication With Healthcare Professionals

Healthcare professionals may need information about how a safety issue interacts with renal function, frailty, polypharmacy, comorbidity or other clinical factors.

A useful communication should make the required action clear without implying that all older patients share the same risk.

Where the evidence applies only to a defined subgroup, the communication should preserve that qualification.

39. Medication-Use Interventions

Some geriatric safety problems are best addressed by improving the way medicines are selected, prescribed, dispensed or administered.

An intervention may therefore involve prescribing support, medication reconciliation, dosing tools, packaging, administration devices or clearer instructions.

Such measures should be assessed against the actual failure mechanism rather than assumed to reduce risk simply because they were implemented.

40. Effectiveness of Risk Minimisation

Where a risk-minimisation measure targets older patients, effectiveness should be evaluated against the defined safety objective.

For example, if the objective is to reduce dosing errors, evidence of distribution of educational material does not demonstrate that dosing errors decreased. If the objective is improved monitoring, the relevant evidence should examine whether monitoring occurred appropriately.

Implementation and effectiveness are therefore distinct endpoints.

41. An Integrated Geriatric Assessment Model

A practical model is:

Older patient exposure
        ↓
Age + function + frailty
        ↓
Comorbidity + polypharmacy
        ↓
Organ function + dose
        ↓
Clinical event
        ↓
Alternative explanations
        ↓
Case / population assessment
        ↓
Signal detection and validation
        ↓
Risk-management decision
        ↓
Communication / implementation
        ↓
Effectiveness and reassessment

The model illustrates why geriatric pharmacovigilance cannot be reduced to age-stratified reporting alone. The safety meaning of an event emerges from the interaction between patient characteristics, exposure and clinical context.

42. QPPV Oversight

The QPPV should have appropriate visibility of significant safety concerns affecting older patients where they could materially affect the pharmacovigilance system or the benefit-risk profile of a product.

This does not mean that the QPPV personally reviews every geriatric case. Effective oversight requires confidence that the system can identify relevant patterns, investigate important concerns and escalate them appropriately.

43. MAH Responsibility

The MAH remains responsible for operating an effective pharmacovigilance system even when specialist geriatric analysis, epidemiology, clinical assessment or data work is performed by external providers.

Responsibilities may be distributed, but the organisation should retain sufficient oversight to understand significant geriatric safety issues and ensure that resulting actions are implemented.

44. Vendor and Affiliate Interfaces

Relevant safety information may originate from affiliates, hospitals, patient-support services, registries, clinical studies or other external sources.

The system should define how important information reaches the responsible pharmacovigilance function and how urgent concerns are escalated.

An organisational boundary should not become an information boundary.

45. Data Quality and Clinical Context

The usefulness of geriatric safety information depends on the availability of clinically meaningful context.

Age, dose, indication, renal or hepatic function, concomitant medicines, baseline disease, frailty and the clinical course may all materially affect interpretation.

The organisation should therefore focus data-quality controls on information that can change the safety conclusion rather than collecting demographic fields without understanding their analytical purpose.

46. Inspection Perspective

An inspection may examine whether the organisation can demonstrate that older-patient safety concerns are considered within its general pharmacovigilance processes and whether relevant evidence is followed through to decision and action.

The key question is not whether the MAH has a separate "geriatric SOP". It is whether the existing system is capable of recognising and appropriately managing safety issues that manifest differently or have greater consequences in older patients.

47. Illustrative Inspection Scenario: Polypharmacy Ignored

A serious event occurs in an older patient taking several medicines, but the case assessment considers only the designated suspect product.

The potential weakness is incomplete causal assessment. Relevant concomitant medicines and interactions should be considered where they could affect interpretation.

48. Illustrative Inspection Scenario: Age Treated as the Cause

A signal review concludes that an event is "age-related" because it occurs predominantly in older patients, without examining exposure, disease, concomitant medicines or background incidence.

The potential weakness is replacing a scientific assessment with an assumption based on age.

Older age can modify susceptibility, but it does not establish causality or explain an event by itself.

49. Illustrative Inspection Scenario: Implementation Mistaken for Effectiveness

An intervention intended to reduce medication errors in older patients is distributed to healthcare professionals, and the organisation records it as successful without examining whether the targeted error changed.

The potential weakness is confusing delivery with achievement of the safety objective.

50. Illustrative Inspection Scenario: Frailty Not Considered

A medicine is associated with an increase in falls, but the assessment does not distinguish robust older adults from patients with significant frailty and baseline mobility impairment.

The potential weakness is loss of clinically relevant population context.

The appropriate analysis depends on the safety question and available evidence, but frailty may materially affect both susceptibility and consequences.

51. Changes in the Safety Profile Over Time

The relevance of geriatric safety information can change as the population using a medicine changes.

An expanding indication, ageing treatment population, longer treatment duration or increased use in multimorbid patients may expose the pharmacovigilance system to safety questions that were less visible earlier in the product lifecycle.

Lifecycle surveillance should therefore remain sensitive to changes in the treated population rather than relying solely on the evidence available at authorisation.

52. New Evidence From Real-World Use

Post-authorisation data may reveal how medicines are actually used in older people, including combinations, doses, treatment durations and patient characteristics that were uncommon in clinical trials.

Such evidence can generate hypotheses about safety, effectiveness or medicine use. It must still be interpreted according to the strengths and limitations of the data source.

A real-world association is evidence to assess, not an automatic causal conclusion.

53. The Benefit-Risk Context

Geriatric safety assessment should be integrated with the therapeutic context.

Older patients may have a high burden of disease and fewer therapeutic alternatives. A medicine-related risk may therefore need to be managed rather than avoided altogether.

This does not lower the standard for identifying or characterising the risk. It determines the appropriate response after the risk has been understood.

54. Avoiding Age-Based Generalisation

Older people should not be treated as a single risk category.

Some older patients have physiological characteristics similar to younger adults, while others have substantial frailty and organ impairment. Some medicines may present greater risks with increasing age, while others may not.

Geriatric pharmacovigilance is strongest when it identifies the characteristics that actually modify risk rather than using chronological age as a surrogate for every relevant factor.

55. A Mature Operating Model

A mature system can be represented as:

General pharmacovigilance system
              ↓
Identify geriatric-relevant safety questions
              ↓
Characterise older population
              ↓
Assess exposure + clinical context
              ↓
Consider comorbidity + polypharmacy + frailty
              ↓
Integrate case and population evidence
              ↓
Determine whether risk differs materially
              ↓
Regulatory / RMP / communication action
              ↓
Verify implementation
              ↓
Assess effectiveness
              ↓
Reassess as population and evidence change

The important point is that geriatric pharmacovigilance is not a parallel system. It is a population-specific application of the general pharmacovigilance system.

56. Practical Review Questions

For a significant safety concern involving older patients, the organisation should be able to answer:

1. What older population is affected?
2. Is chronological age sufficient to define the relevant subgroup?
3. What were the actual dose and exposure?
4. Was renal or hepatic function relevant?
5. What concomitant medicines were present?
6. Could the underlying disease explain the event?
7. Was frailty or functional status relevant?
8. What is the appropriate background incidence?
9. Is the event phenotype different in older patients?
10. Does the evidence support an age-specific or vulnerability-specific association?
11. Does the finding affect the benefit-risk assessment?
12. Does the RMP or product information require reassessment?
13. Is additional evidence generation justified?
14. Is risk communication or minimisation required?
15. Can implementation and effectiveness be demonstrated?
16. Can the complete decision chain be reconstructed?

These questions provide a practical test of whether the organisation has addressed the clinical context rather than simply counting reports from older patients.

57. Final Principle

The central challenge in geriatric pharmacovigilance is distinguishing the effect of a medicine from the complex clinical environment in which medicines are used by older people.

Ageing, frailty, multimorbidity, polypharmacy and altered drug handling can increase vulnerability, change clinical presentation and complicate causal assessment. None of these factors, individually, establishes that a medicinal product caused an event.

The appropriate approach is therefore systematic: characterise the patient and exposure, reconstruct the clinical context, evaluate competing explanations, integrate individual and population evidence, and determine whether the finding changes the understanding or management of the medicine's safety profile.

Key Takeaways

Geriatric pharmacovigilance is an application of the general EU pharmacovigilance framework to a population in which age, frailty, comorbidity, polypharmacy and altered physiology can materially affect safety interpretation.

Older patients should not be treated as a homogeneous category. The relevant safety question may depend on functional status, organ function, treatment burden, disease and actual exposure as much as on chronological age.

The strongest assessments distinguish medicine-related effects from background disease, other medicines, medication errors and age-associated events. Where a geriatric-specific risk is identified, the conclusion should flow into the appropriate regulatory, risk-management, communication and evidence-generation processes.

Regulatory Note

This article does not represent a dedicated GVP geriatric module. EMA's current GVP framework lists final product- or population-specific considerations for vaccines, biological medicinal products, pregnancy/breastfeeding and paediatric populations, but not a separate final geriatric chapter. citeturn0search0

The geriatric considerations discussed here are based on the general EU pharmacovigilance framework together with EMA and ICH scientific guidance concerning older people. They should not be read as additional legally binding pharmacovigilance requirements unless the applicable legislation or regulatory guidance expressly establishes such a requirement.

Inspection scenarios are illustrative and are not presented as documented regulatory findings.

References

1. European Medicines Agency. Medicines for older people.
2. European Medicines Agency. Geriatric Medicines Strategy, EMA/CHMP/137793/2011.
3. European Medicines Agency. Reflection paper on the pharmaceutical development of medicines for use in the older population, EMA/CHMP/QWP/292439/2017.
4. European Medicines Agency. ICH E7: Studies in support of special populations: geriatrics, EMA/CHMP/604661/2009.
5. European Medicines Agency. Good Pharmacovigilance Practices (GVP), Module I — Pharmacovigilance systems and their quality systems.
6. European Medicines Agency. Good Pharmacovigilance Practices (GVP), Module IX — Signal management.
7. European Medicines Agency. Good Pharmacovigilance Practices (GVP), Module V — Risk management systems.
8. Regulation (EC) No 726/2004, as amended.
9. Directive 2001/83/EC, as amended.
10. Commission Implementing Regulation (EU) No 520/2012, as amended.