2008 04 24 Malmo Helge Risk Management

8/13/2019 2008 04 24 Malmo Helge Risk Management

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Risk

ManagementPlan24. April 2008

Helge Gydesen

Epidemiology

Novo Nordisk A/S


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Agenda

Regulatory environment2

What is a Risk Management Plan3

Implications for post marketing activities5

Who, When and How4

Conclusions6

Motivation: Examples of withdrawals1


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Regulatory guidance

Three guidelines from FDA

The ICH E2E Guideline

EU risk management Guideline

All can be found on International Society forPharmacoEpidemiology (ISPE) homepagewww.pharmacoepi.org under the left hand headingresources
http://www.pharmacoepi.org/http://www.pharmacoepi.org/


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Risk management-Definition and purpose

A Risk Management system is a set of pharmacovigilanceactivities and interventions designed to proactively identify,characterise and prevent or minimise risks relating tomedicinal products, including risk communication and theassessment of the effectiveness of risk minimisation

interventions. The purpose of the Risk Management Plan (RMP) is:

to identify the risks associated with a medicinal product

develop methods to clarify further the safety profile of aproduct

plan ways to minimise risk to individual patients in clinical use.


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Risk Management Plan Development


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Risk management- The role of Epidemiology

Author and maintain the epidemiological sections of a Risk Management Plan(RMP) as per guidelines from regulatory authorities and NN SOP on ongoingbasis. Support the updating of RMP periodically. Provide epidemiologicalexpertise in Risk management activities throughout the life cycle of NNproducts.

Provide timely epidemiology support to project teams to design and

implement epidemiological studies, to review study proposal from internaland external sources, to analyze adverse events reporting data, and tointerpret and report on data analysis results to other line functions.

Contribute in safety risk evaluation once a safety signal has been detectedand in communication of safety information and thereby propose andimplement risk minimization activities.

Provide epidemiology support in preparation of Periodic/ Annual SafetyReports (PSUR/ASR) if required by the regualatory authorities.


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When to start the work with the RMP?

Approval

Pharmacovig i lance

Product

Life Cycle

Exposure

(Potential Denominator)FIM Phase I Phase II

Phase IIIPhase IV

Drug Discovery/Preclinical Clinical Development Post Marketing


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RMP: A change in approach

Proactive in stead of reactive

Not a defensive approach, in stead: demonstrate safety

Focus on different type of epidemiological studies instead of normal pharmacovigilance

Pharmaco epidemiology in stead of standardpharmacovigilance


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Risk management Plans examples ofidentified risks: EXUBERA

Smoking-induced alterations in Pharmacokinetics (druginteraction studies/passive smoking)

Changes in Pulmonary Function (Long term PASS,Special Asthma study, Paediatric studies)

Increased Insulin Antibody Levels (Long term PASS,Paediatric studies)

Rare Pulmonary Events (Epi Lung Cancer study)

11 studies running until 2019, covering more than 75000patients


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Any questions or comments?


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2008 04 24 Malmo Helge Risk Management