Federal agency for medicines and health products

DG Inspection: A general overview

Josiane Van der Elst – 26 June 2012

Subjectfamhp/entity/Division-Unit-Cell

DatePage number

The Agency and DG Inspection

Mission defining the main task of DG Inspection

Vision: philosophy and destination of DG Inspection

Strategic pillarsBe professional, dare to have strong objectivesA policy of control in pace with environmentBe in dialogue with stakeholdersHave strong internal backboneCommunicate when and where necessaryBe known - Visibility

Menu

The Agency

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Organisation chart FAMHP

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Organisation chart FAMHP

Directorate General Inspection: Mission and Vision

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• Safeguarding, from development to use, the quality of

medicines and health products by organising inspections

and controls in the different fields of competency of the

FAMHP

• Delivering authorisations, declarations, certificates, licenses

corresponding to the different fields of competency of the

DG Inspection

• Fighting against crime related to medicines and health

products

Mission of DG Inspection

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Inspections Autorisations

Medicines• GxP

Health Products• Medical Devices: Distributors and Class 1 manufacturers • Blood, Cell and Tissue Establishments

Promotional activities / advantages

Industry division

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Inspections Autorisations

• Authorisations manufacturing and distribution

• Declarations export declaration subcontracting declarationclinical trials declaration

• Certificates GMP certificates, including Eudra GMP Certificates for exportation:

CPP

• Accreditation Qualified Persons IndustryQualified Persons

PharmacoVigilancePersons Responsible for

Information

• Agreements Blood, Cell and Tissue Establishments

Industry division

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Inspections Administration

Pharmacies open to the public Opening, transfer and closure of

pharmacies Land Register

Hospital Pharmacies

Veterinary depots Notifications

Special regulated substances Authorisations narcotics and psychotropics Licenses

(import/export) precursors hormones

Dispensing Division

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Fighting crime related to the manufacturing,

distribution, dispensing of medicines and health products

• Counterfeit products trying to penetrate the legal circuit

• Illegal circuit, illicit products, for instance fighting illegal websites

Special Investigation Unit

Médicaments par internet ?

Ne surfez pas

avec votre santé !

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Vision: What is Inspection?

Wikipedia

An inspection is, most generally, an organized examination or

formal evaluation exercise.

The results are usually compared to specified requirements and

standards for determining whether the item or activity is in line

with these targets.

Inspections are used for the purpose of determining if a body iscomplying with regulations.

The inspector examines the criteria and talks with involvedindividuals. The result is an evaluation report.

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Vision: What is Inspection?

Inspection IS NOT

• inquisition

• only information

• consultancy

Inspection IS

• Verifying compliance with the law and guidelines

• According to standard procedures

• Result - driven, “finalité”

• Enforcement in case of intentional offences, intentional breach

of law

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Vision: Inspection in a changing environment The world is changing

New technologies and products are emerging

Globalisation

Societal implication is increasing

Demand for transparency is increasing

Complexity is increasing

Reaction: reality is changing:ignore or adapt

Darwinistic vision:

Inspection has to adapt in order to keep in touch with changing

reality, in order to be fit to perform its mission

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Vision: Style of inspection

AS IS: Gothic style

Strong vertical elements

One - to - one communication

Within DG Inspection: boxed

Inspection uniquely by competent autority

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Vision: Style of inspection

TO BE: Inspection” Art Nouveau”

Century turn 1890 – 1910

Curvilinear: both rigid and flexible

Harmonisation with environment

Within DG Inspection: Search linkage, thematic inspectionsAdopt attitude for more risk - based inspection

Combination of uniquely authority - executed control and “delegated” type of control but which stays authority - driven

Directorate General Inspection : Strategic pillars

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Strategic pillar 1: Strong objectives

• Specific surveillance leading to security:

• an inspection has a clearly pre-defined goal

• alert systems in place

• Pro-active product surveillance

• Time-bound:

• respect legal delays where of application

• timely interventions

• reasonable reaction time to complaints

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Strategic pillar 1: Strong objectives

• Result-oriented finality:

• is the law respected ? if not: deliberately or non-deliberately

• rationalise

• administrative simplification

• Open:

• understandable, no hidden agenda, what you see is what you get

• Service-oriented ; fee for service is justifiable

• Measurable

• Transparancy

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Strategic pillar 1: Strong objectives

• Negociable:

• in terms of having an attitude to set out acceptable and realistic

criteria for the parties involved

• not in terms of being bribable

• Good:

• give enough inspiration for the parties involved

• keep the spirit of wanting to evolve together

• instal climat of mutual trust within the limits of each’s playing field

Strategic Choice in order to keep in rythm with increasing complexity

Rethink methodology of inspection

Introduction of autocontrol

Trust = delegate part of the inspection to an interface with a feedback

Invest capacity rationally more in high risk fields

If trust is shamed: trial, no pardon, zero tolerance

If trust is honoured: reward

Introduction and promotion of transversal inspections

Equipe -based

A more rational use of capacity

Strategic pillar 2: control policy:trust and trial, ratio and reward

Strategic pillar 3: Partnership

Be in dialogue with stakeholders

Protocols of cooperation

Concertation platforms on important files, on changing legislation

Informal platforms

Fora (regulatory, scientific, industrial,…)

Meetings with Inspection to resolve specific questions

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Strategic pillar 4: Have a strong internal backbone

Strong internal structure and organisation allowing to be

performant in doing inspections

Based on the life cycle of an inspection

Planning of inspections

Execution of inspections

Issuing of authorisations and certificates

Intelligence input from the above for the planning of new

inspections

Based on equitable repartition of tasks

Divisions of Industry and Dispensing “overloaded”

DG Inspection: current structure

Director General

Division IndustryPlanning of inspections

Execution of inspectionsIssuing of

authorisations

Division DispensingPlanning of inspections

Execution of inspectionsIssuing of

authorisations

Special Investigation Unit

Control policy

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DG Inspection: new structure

Director General

Division Industry

Execution of inspections

Division Dispensing

Execution of inspections

Special Investigation Unit

Division Autorisations

Issuing of autorisations

Staff Inspection management

Planning of inspections(Ex - Control policy)

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Strategic pillar 4: Have a strong internal backbone

Work in a context of TQM

Rationalise meetings

Promote telework

Free zone office (Pilot for Agency)

Learning spirit

Valorise expertise

Soft skills

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Strategic pillar 5: Communicate

In a direct univocal way

Business rules of communication

On items important to the stakeholders

Unavailability of medicines

Counterfeit and illicit medicines

Feedback from international fora

Complaints

Know our faces

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Strategic pillar 6: Be known-Visibility

Inspection is out there on the streets

Representation at national fora

BRAS, UPIP/VAPI, MDHC, ICCF, ICCV, …

Response to parlimentary question

Representation at international fora

JAP

PIC/s

EMA / HMA / EC

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In other words, DG Inspection

A new structure

A new style

Federal agency for medicines and health products - famhp

Place Victor Horta 40/40 1060 Bruxelles

tel. 0032 2 524 80 00fax 0032 2 524 80 01

e-mailwelcome@fagg-afmps.be

www.afmps.be

Contact

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Your medicines and health products,our concern