Module 1 2021

28/06/2021

Risk Minimization Measures

• Post-Authorization Safety Studies, PASS, should be proposed to address the uncertainties in the safety profile of the product, usually the long-term safety. • Risk Minimization activities or measures are the activities that the company has to put in place to ensure that the patient is protected against unwanted and sometime unknown side effects. • For instance, warnings and precautions in the labeling or patient alert cards. • With the RMP being a part of the approval, the approach nowadays is more pro- active, risk-based and addressing uncertainties. • This approach should also be applied within companies • Teams with specific expertise • (Proactively) define the risk minimization measures and design the post- approval studies.

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Post-Approval Safety Example: The volume of post-approval safety label changes of a TNF-blocker*

Infections in the elderly

Cardiomyopathy, parasitic infections Sarcoidosis

TB, skin and subcutaneous tissue disorders

Invasive fungal infections, aspergilosis

Delayed Hypersensitivity

Invasive fungal infections

Opportunistic Infections

ILD, AEs with fatal outcome

Agranulocytosis, Pancreatitis

CD: 2 nd to 3 rd line therapy

Demyelinating disorders Oligosaccharides

Heart failure

Interstitial pneumonitis /fibrosis

HSTCL

Peripheral demyelination

Severe infections

Extrapulmonary TB

Vasculitis

HSTCL

Pregnancy

MA

1999 2000 2001 2002 2003 2004

2006 2005 2007 2008 2009 2010 2011 2012

2013

HBV reactivation

Serum sickness, Pericardial effusion

Readministration

Pancytopenia Listeriosis

HBV

Hepatotoxicity

ADR frequencies

Multiorgan complications, opportunistic infections Paediatric malignancy, leukaemia

Malignancies in COPD

Transverse myelitis, Anemia, Hepatocellular damage

Safety in juvenile RA

New onset psoriasis, pustular psoriasis, hepatobiliary events

Malignancies

Pneumonia

BIOSIMILARS

* Ref: EPAR Remicade®

Viral infections, switching between biological DMARDs, neutropenia, hematologic reactions

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