hoe gaat de overheid hiermee om? wat zijn de overwegingen? wanneer wordt bijv. besloten tot...

Hoe gaat de overheid hiermee om? Wat zijn de overwegingen? Wanneer wordt bijv. besloten tot verkorting van de PSUR cycle

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

wetgeving

Council regulation

• 2309/93

• 540/95

Directive 75/319 as amended

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

• System for drug surveillance (National pharmacovigilance centre) for receipt and evaluation of all pharmacovigilance data within that Member State

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

The CA as part of its obligation to undertake ongoing evaluation of risk benefit assessment, must ensure that all pharmacovigilance data received and outlined are taken into account on an ongoing basis

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

• Individual adverse reaction reports

• Periodic Safety Reports

• Company Sponsored Post Authorisation Safety Studies

• Pharmacovigilance data from other sources

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

• Objective: provide an update of the world wide safety experience

• The regulatory authorities regard the PSURs as important summaries and analyses of drug safety data

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

• With a focus on all serious and non serious unlisted adverse events they can prove a valuable source of drug safety signals

• The accumulation of all clinical safety data from all relevant sources provides an excellent opportunity to carry out an overall safety evaluation of the product

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

PSUR European PSURs follow the format and content for safety updates as ICH E2C requirements

European authorization National authorization

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

Waarde van de PSUR

• Kwaliteit

• Mening registratiehouder

• Spontane meldingen

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

Waarde van de PSUR

• Causality assessment

• Underreporting

• Vulnerabilty to external events

overemphasis on rare ADRs

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

Aandachtspunten

ICH E2CCyclus

Summary Bridging rapport

CCDS

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

Instrumenten:

Aanpassen SPC Verandering cyclus Closely monitoring

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

Toekomst • ICH E2E

• Eudravigilance database

• Work sharing

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

Surveillance

• Describe patterns of occurrence

• Identify unusual events

• Provide early warnings

• Track trends

C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

wetgeving

• Volume 9

• ICH E2C

• ICH E2E

Major issue spontaneous data

• Draw conclusion from inaccurate data

At best provide a signal

At worst eschew patients form beneficial

therapies.

• Fatal ADRs are between the fourth and the sixth leading cause of death

• Some ADRs are understood recognized and accepted as necessary side effects to achieve desired benefit

Purpose of surveillance

• Describe patterns of occurrence

• Identify unusual events

• Provide early warnings

• Track trends

• Spontaneous reports are the major source

• In the US 90% are submitted by the MAHs

• Drawbacks

• Estimates are imprecise

• ADRs are a major public health problem